<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/NCT03273101</url>
  </required_header>
  <id_info>
    <org_study_id>2014.427</org_study_id>
    <nct_id>NCT03273101</nct_id>
  </id_info>
  <brief_title>Sit-to-stand Training in Stroke Patient</brief_title>
  <official_title>Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tai Po Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tai Po 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>
      Background: It is unknown whether the self-initiated sit-to-stand training with assistive&#xD;
      device is effective to regain the independence of sit-to-stand in stroke patients.&#xD;
&#xD;
      Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive&#xD;
      device, with manual sit-to-stand training.&#xD;
&#xD;
      Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May&#xD;
      2018. Randomisation was performed by drawing lots to allocate treatment to patient.&#xD;
&#xD;
      Setting: A rehabilitation hospital in Hong Kong&#xD;
&#xD;
      Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients&#xD;
      fulfilled the study requirements.&#xD;
&#xD;
      Intervention: Ten sessions of intervention with conventional physiotherapy program followed,&#xD;
      by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand&#xD;
      training.&#xD;
&#xD;
      Main outcome measure: Number of patients regained the independence of sit-to-stand,&#xD;
      Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.&#xD;
&#xD;
      Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD,&#xD;
      10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients&#xD;
      were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26)&#xD;
      patients for per protocol analysis. 18 patients in intervention group and 10 patients in&#xD;
      control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and&#xD;
      0.31). The patients in intervention group were faster to complete the Five-repetition&#xD;
      sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95%&#xD;
      confidence interval, -30.8 to -0.7; p&lt;0.05). No adverse side effects occurred during and&#xD;
      after the training across groups.&#xD;
&#xD;
      Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke&#xD;
      patients regain the independence of sit-to-stand.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Number of patients regained the independence of sit-to-stand</measure>
    <time_frame>After 10 sessions of training</time_frame>
    <description>To compare how many patients can regain the independence of sit-to-stand between groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sit-to-Stand Test (SST) from the Balance Master®</measure>
    <time_frame>After 10 sessions of training</time_frame>
    <description>To assess the quality of sit-to-stand of patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Five-Repetition Sit-to-Stand Test</measure>
    <time_frame>After 10 sessions of training</time_frame>
    <description>To assess the functional strength of lower limb, balance and transition move of patient</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sit-to-stand training is assisted by mechanical device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The sit-to-stand training is assisted by manual device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical assisted sit-to-stand training group</intervention_name>
    <description>Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>sit-to-stand trainer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual assisted sit-to-stand training group</intervention_name>
    <description>Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>physiotherapist assisted</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first episode of unilateral stroke with hemiparesis,&#xD;
&#xD;
          -  able to understand and follow simple verbal instructions,&#xD;
&#xD;
          -  able to sit unsupported for at least two minutes&#xD;
&#xD;
          -  require lifting assistance to stand up from a 18 inches high plinth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe pain in the lower extremities when weight bearing or performing movement&#xD;
&#xD;
          -  any other acute comorbid diseases such as unstable angina, recent myocardial&#xD;
             infarction&#xD;
&#xD;
          -  unstable medical / psychological condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ng Chee Man, Joey, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tai Po Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Woo Ka Ho, Marc, Master</last_name>
    <role>Study Director</role>
    <affiliation>Prince of Wales Hospital</affiliation>
  </overall_official>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tai Po Hospital</investigator_affiliation>
    <investigator_full_name>Ng Chee Man, Joey</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03273101
org study id: 2014.427
nct id: NCT03273101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: It is unknown whether the self-initiated sit-to-stand training with assistive
      device is effective to regain the independence of sit-to-stand in stroke patients.

      Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive
      device, with manual sit-to-stand training.

      Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May
      2018. Randomisation was performed by drawing lots to allocate treatment to patient.

      Setting: A rehabilitation hospital in Hong Kong

      Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients
      fulfilled the study requirements.

      Intervention: Ten sessions of intervention with conventional physiotherapy program followed,
      by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand
      training.

      Main outcome measure: Number of patients regained the independence of sit-to-stand,
      Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.

      Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD,
      10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients
      were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26)
      patients for per protocol analysis. 18 patients in intervention group and 10 patients in
      control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and
      0.31). The patients in intervention group were faster to complete the Five-repetition
      sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95%
      confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and
      after the training across groups.

      Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke
      patients regain the independence of sit-to-stand.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of patients regained the independence of sit-to-stand
time frame: After 10 sessions of training
description: To compare how many patients can regain the independence of sit-to-stand between groups
measure: Sit-to-Stand Test (SST) from the Balance Master®
time frame: After 10 sessions of training
description: To assess the quality of sit-to-stand of patient
measure: Five-Repetition Sit-to-Stand Test
time frame: After 10 sessions of training
description: To assess the functional strength of lower limb, balance and transition move of patient
arm group label: Intervention group
arm group type: Experimental
description: The sit-to-stand training is assisted by mechanical device
arm group label: Control group
arm group type: Active Comparator
description: The sit-to-stand training is assisted by manual device
intervention type: Device
intervention name: Mechanical assisted sit-to-stand training group
description: Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
arm group label: Intervention group
other name: sit-to-stand trainer
intervention type: Other
intervention name: Manual assisted sit-to-stand training group
description: Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
arm group label: Control group
other name: physiotherapist assisted
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ng Chee Man, Joey, Master
role: Principal Investigator
affiliation: Tai Po Hospital
last name: Woo Ka Ho, Marc, Master
role: Study Director
affiliation: Prince of Wales Hospital
responsible party type: Principal Investigator
investigator affiliation: Tai Po Hospital
investigator full name: Ng Chee Man, Joey
investigator title: Principal investigator
mesh term: Stroke
sharing ipd: No