<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441437</url>
  </required_header>
  <id_info>
    <org_study_id>104-9569A3</org_study_id>
    <nct_id>NCT04441437</nct_id>
  </id_info>
  <brief_title>The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients</brief_title>
  <official_title>The Efficacy of Dynamic Hand Splint Treatment in Spastic Hemiparetic Patients: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized controlled trial was designed to study the efficacy of dynamic&#xD;
      hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were recruited from both inpatients and outpatients who received rehabilitation&#xD;
      programs in the Department of Physical Medicine and Rehabilitation at a regional teaching&#xD;
      hospital in Taiwan. The participants were randomly divided into two groups: the splint group&#xD;
      and the control group. The subjects in the splint group received 1-hour task-oriented&#xD;
      training with wearing a customized dynamic hand splint, totally 15 times in a duration of one&#xD;
      month plus conventional rehabilitation programs. The subjects in the control group received&#xD;
      the same treatments but without splint used. Evaluations including Modified Ashworth Scale&#xD;
      (MAS), active range of motion (AROM), grip strength, Fugl-Meyer Assessment (FMA), Motor&#xD;
      Activity Log 30(MAL), and F/M ratio were performed at baseline, post-training, and 2 months&#xD;
      later after the intervention finished, and the evaluators were blinded to the grouping of the&#xD;
      subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 4, 2016</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of Modified Ashworth Scale (MAS)</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of Modified Ashworth Scale (MAS)</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Active range of motion (AROM)</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of Active range of motion (AROM)</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of Active range of motion (AROM)</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of Grip strength</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of Grip strength</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor Activity Log 30(MAL)</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of Motor Activity Log 30(MAL)</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of Motor Activity Log 30(MAL)</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>F/M ratio of ulnar nerve</measure>
    <time_frame>Performed at baseline</time_frame>
    <description>An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-training Change of F/M ratio of ulnar nerve</measure>
    <time_frame>Change from baseline at average 30 days</time_frame>
    <description>An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-Month Follow-up Change of F/M ratio of ulnar nerve</measure>
    <time_frame>Change from baseline at average 90 days</time_frame>
    <description>An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Stroke</condition>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Splint Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-Splint Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Task-oriented training with a dynamic hand splint</intervention_name>
    <description>In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.</description>
    <arm_group_label>Splint Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Task-oriented training without a dynamic hand splint</intervention_name>
    <description>In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the no-splint group received 1-hour task-oriented training, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.</description>
    <arm_group_label>No-Splint Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an age of 20 to 85 years&#xD;
&#xD;
          -  the duration of stroke or brain injury more than 6 months&#xD;
&#xD;
          -  unilateral hemiparesis with intact sound side limbs function&#xD;
&#xD;
          -  the Brunnstrom's stage of both arm and hand ≥ III&#xD;
&#xD;
          -  able to follow instructions, wear a dynamic hand splint and perform therapeutic&#xD;
             activities&#xD;
&#xD;
          -  wrist spasticity with a Modified Ashworth Scale score 1-3&#xD;
&#xD;
          -  willing to provide the written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with apraxia&#xD;
&#xD;
          -  cognitive impairment with a Mini-Mental State Examination (MMSE) score &lt; 25&#xD;
&#xD;
          -  any fixed contracture of the affected wrist or fingers&#xD;
&#xD;
          -  a history of peripheral nerve injury, other severe neuromuscular disease or&#xD;
             musculoskeletal deformity change in the affected side upper extremity&#xD;
&#xD;
          -  a history of alcohol or phenol injection to the affected side upper extremity&#xD;
&#xD;
          -  Botulinum toxin injection to the affected side upper extremity for the treatment of&#xD;
             spasticity within 4 months before the study&#xD;
&#xD;
          -  surgical treatment for spasticity to the affected side upper extremity&#xD;
&#xD;
          -  active infection&#xD;
&#xD;
          -  obvious atrophy of muscles in the affected side upper extremity&#xD;
&#xD;
          -  bilateral upper extremities weakness&#xD;
&#xD;
          -  any dermatosis or open wounds in the affected upper extremity or an allergy to the&#xD;
             splint.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chu-Hsu Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Chu-Hsu Lin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>spasticity</keyword>
  <keyword>dynamic hand splint</keyword>
  <keyword>stroke</keyword>
  <keyword>traumatic brain injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441437
org study id: 104-9569A3
nct id: NCT04441437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized controlled trial was designed to study the efficacy of dynamic
      hand splinting on spastic hemiparetic patients due to stroke or traumatic brain injury.
Subjects were recruited from both inpatients and outpatients who received rehabilitation
      programs in the Department of Physical Medicine and Rehabilitation at a regional teaching
      hospital in Taiwan. The participants were randomly divided into two groups: the splint group
      and the control group. The subjects in the splint group received 1-hour task-oriented
      training with wearing a customized dynamic hand splint, totally 15 times in a duration of one
      month plus conventional rehabilitation programs. The subjects in the control group received
      the same treatments but without splint used. Evaluations including Modified Ashworth Scale
      (MAS), active range of motion (AROM), grip strength, Fugl-Meyer Assessment (FMA), Motor
      Activity Log 30(MAL), and F/M ratio were performed at baseline, post-training, and 2 months
      later after the intervention finished, and the evaluators were blinded to the grouping of the
      subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Modified Ashworth Scale (MAS)
time frame: Performed at baseline
description: A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
measure: Post-training Change of Modified Ashworth Scale (MAS)
time frame: Change from baseline at average 30 days
description: A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
measure: 3-Month Follow-up Change of Modified Ashworth Scale (MAS)
time frame: Change from baseline at average 90 days
description: A participant was made in sitting position with the palm of the affected side placed at the edge of table. Then his or her 2nd to 5th fingers was moved by the examiner from maximum possible flexion to maximum possible extension over a duration of about one second. All of the four fingers were done at once. The participant's wrist and elbow were then also tested in the same manner. The lowest score was zero and the highest score was 415. For statistical purposes, the MAS score '1+' is considered as 2, '2' as 3, and so on until 5.
measure: Active range of motion (AROM)
time frame: Performed at baseline
description: A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
measure: Post-training Change of Active range of motion (AROM)
time frame: Change from baseline at average 30 days
description: A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
measure: 3-Month Follow-up Change of Active range of motion (AROM)
time frame: Change from baseline at average 90 days
description: A participant in sitting position with the palm of the affected side placed at the edge of table was instructed to actively move his or her fingers and wrists as much as possible. Then the AROM of the index finger and wrist were measured by a goniometer.
measure: Grip strength
time frame: Performed at baseline
description: For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
measure: Post-training Change of Grip strength
time frame: Change from baseline at average 30 days
description: For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
measure: 3-Month Follow-up Change of Grip strength
time frame: Change from baseline at average 90 days
description: For the grip strength measurement, a participant in sitting position was instructed to squeeze a dynamometer with the unaffected hand as hard as he or she can for about 3 seconds. Then the hand of affected side was tested in the same manner. Three consecutive measurements with a 3-minute interval were performed for each hand and the arithmetic mean value of the 3 trials was used for statistical analysis.
measure: Motor Activity Log 30(MAL)
time frame: Performed at baseline
description: Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
measure: Post-training Change of Motor Activity Log 30(MAL)
time frame: Change from baseline at average 30 days
description: Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
measure: 3-Month Follow-up Change of Motor Activity Log 30(MAL)
time frame: Change from baseline at average 90 days
description: Using the standardized questions from the upper-extremity MAL, a participant was rated how much (Amount of Use scale, MAL-AOU) and how well (Quality of Movement scale, MAL-QOM) he or she used the upper limb of affected side to accomplish each functional activity during the past week. Both scales were anchored at 6 points (AOU scale: 0 = not used, 5 = the same as before stroke or brain injury; QOM scale: 0 = not used, 5 = normal).17, 18 A mean MAL score is the mean of all item scores.
measure: Fugl-Meyer Assessment (FMA)
time frame: Performed at baseline
description: For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
measure: Post-training Change of Fugl-Meyer Assessment (FMA)
time frame: Change from baseline at average 30 days
description: For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
measure: 3-Month Follow-up Change of Fugl-Meyer Assessment (FMA)
time frame: Change from baseline at average 90 days
description: For the Fugl-Meyer Upper Extremity Assessment (FMA), a 3-graded scale with 0 as minimum and 2 as maximum was applied for grading of sensorimotor function.19 The testing procedure was conducted in a standardized manner according to the written instructions originally published and some additional general guidelines.20, 21 For motor function assessment, the Fugl-Meyer Assessment for upper extremity (FMA-UE) was used. Clear and precise instructions were given to a seated participant for each movement. The unaffected side simulated first and then the affected side was evaluated. Each activity was repeated 3 times and the highest score was recorded. The maximum total score was 66. For sensory function assessment, the Modified Fugl-Meyer sensory assessment (FMA-sensory) was used. This included tests of the light touch, temperature, tactile localization and position sensation of the upper arm, forearm, hand, thigh, calf and foot of the affected side. The maximum total score was 44.
measure: F/M ratio of ulnar nerve
time frame: Performed at baseline
description: An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.
measure: Post-training Change of F/M ratio of ulnar nerve
time frame: Change from baseline at average 30 days
description: An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.
measure: 3-Month Follow-up Change of F/M ratio of ulnar nerve
time frame: Change from baseline at average 90 days
description: An electrophysiological examination was performed with an active recording surface electrode (G1) placed over the belly of the abductor digiti minimi of the affected side, a reference electrode (G2) placed on the phalanx of the little finger, and a ground electrode placed on the back of the hand between the stimulating and recording electrodes. Supra-maximal stimulations at the wrist 8 cm away from G1 was performed to obtain the compound muscle action potential (CMAP) and F wave of the ADM muscle with the cathode distal and proximal to the anode, respectively. The stimulation was given less than 1 Hz to avoid influences from the previous stimulus. The ratio of amplitude of the mean and the maximal F-wave to the CMAP (F/M ratio) were then calculated.
arm group label: Splint Group
arm group type: Experimental
description: 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month.
arm group label: No-Splint Group
arm group type: Placebo Comparator
description: 1-hour task-oriented training without wearing a customized dynamic hand splint, totally 15 times in a duration of one month.
intervention type: Behavioral
intervention name: Task-oriented training with a dynamic hand splint
description: In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
arm group label: Splint Group
intervention type: Behavioral
intervention name: Task-oriented training without a dynamic hand splint
description: In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the no-splint group received 1-hour task-oriented training, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
arm group label: No-Splint Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chu-Hsu Lin, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Chu-Hsu Lin
investigator title: Principal Investigator
mesh term: Brain Injuries
sharing ipd: No