<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/NCT03791671</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01700</org_study_id>
    <nct_id>NCT03791671</nct_id>
  </id_info>
  <brief_title>Balance Training After Stroke - a Randomized, Controled Pilot Study</brief_title>
  <official_title>Individual Balance Training vs. Group Balance Training to Improve Walking Speed Post Stroke - a Randomized, Controled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RehaClinic AG</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RehaClinic AG</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>
      This pilot study is part of a master's thesis. In the rehabilitation of stroke patients&#xD;
      should be compared whether individual balance training has a greater effect than group&#xD;
      balance training. The result is determined based on the walking speed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The RehaClinic Kilchberg is a neurological rehabilitation facility with the phases B-D.&#xD;
      Between February and the end of March, out of 78 patients, 71% of the patients had a stroke.&#xD;
      Therefore, my choice of topic for the Master's thesis fell on balance training of patients&#xD;
      after a stroke. The duration of the study is based on the timetable for the Master's thesis.&#xD;
      Initially, 20 stroke patients will be recruited. When the number is reached, the study is&#xD;
      completed to begin descriptive statistics and analyze potential BIAS.&#xD;
&#xD;
      Deficits in the vestibular, visual, motor, and / or somatosensory systems lead to falls in&#xD;
      the first 6 months after the stroke. This affects approximately 46% of patients. But also&#xD;
      cognitive processes, such as attention and concentration. Therefore, the treatment must be&#xD;
      adapted to the respective strategy of the patient. If the patient increasingly uses the&#xD;
      visual system, the therapy has to work a lot with the eyes closed. In turn, if he uses more&#xD;
      of the sensorimotor system is increasingly trained with unstable documents. After this&#xD;
      system, the balance program was set up. It is the same for the intervention and control group&#xD;
      to make a difference between individual and group training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 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>
    <intervention_model_description>There will be a intervention group and a control group. Both groups do active treatment. In the intervention group they will have individual balance training and in the control group they will have balance training in a group from 3-6 persons. But both groups will do the same balance program.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the walking speed at three weeks</measure>
    <time_frame>Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion</time_frame>
    <description>10m walking test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the balance score at three weeks</measure>
    <time_frame>Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion</time_frame>
    <description>The Berg Balance Scale is used to determine the risk of falling. The BBS detects deficits at both activity and body function levels. It consists of 14 items. Some items require that the patient maintains positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Scaling takes place from 0 points (not possible) to 4 points (independently possible). This results in a total score of 56 points. The cut-off is at 45 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Walking ability (walking aid) at three weeks</measure>
    <time_frame>Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion</time_frame>
    <description>Functional Ambulation categories - is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>individual balance training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the initial assessments, the three week intervention time begins, which is completed with the reassessments.&#xD;
The patients receive 2x weekly individual balance training for 25 minutes each. This runs in addition to the normal, prescribed rehabilitation program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group balance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients receive 2x weekly group balance training for 25 minutes each. This runs in addition to the normal, prescribed rehab program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.&#xD;
In group therapy are 3 to 6 patients with different neurological diagnoses. As it is usual in rehabilitation everyday life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>individual balance training</intervention_name>
    <description>One physiotherapist trains one Patient nearby a bar. The tasks changes in gage, visual feedback, vestibular feedback and underground. The Positions will be hodl for 10-30 seconds.</description>
    <arm_group_label>individual balance training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>group balance training</intervention_name>
    <description>Like the individual balance training</description>
    <arm_group_label>group balance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke starting from Rehabilitation phase B&#xD;
&#xD;
          -  ability to understand therapy instructions&#xD;
&#xD;
          -  walkable with aids&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurodegenerative disease&#xD;
&#xD;
          -  non-stroke dizziness&#xD;
&#xD;
          -  cardiopulmonary insufficiency&#xD;
&#xD;
          -  polyneuropathy&#xD;
&#xD;
          -  peripheral vascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yvonne Teuschl, Ass.-Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Donauuniversität Krems (Danube University)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RehaClinic Kilchberg</name>
      <address>
        <city>Kilchberg</city>
        <state>Zurich</state>
        <zip>8802</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.rehaclinic.ch</url>
    <description>RehaClinic AG</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RehaClinic AG</investigator_affiliation>
    <investigator_full_name>Mrs. Wiebke Weigert</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Balance training</keyword>
  <keyword>Gait Speed</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03791671/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03791671/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03791671
org study id: 2018-01700
nct id: NCT03791671
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is part of a master's thesis. In the rehabilitation of stroke patients
      should be compared whether individual balance training has a greater effect than group
      balance training. The result is determined based on the walking speed.
The RehaClinic Kilchberg is a neurological rehabilitation facility with the phases B-D.
      Between February and the end of March, out of 78 patients, 71% of the patients had a stroke.
      Therefore, my choice of topic for the Master's thesis fell on balance training of patients
      after a stroke. The duration of the study is based on the timetable for the Master's thesis.
      Initially, 20 stroke patients will be recruited. When the number is reached, the study is
      completed to begin descriptive statistics and analyze potential BIAS.

      Deficits in the vestibular, visual, motor, and / or somatosensory systems lead to falls in
      the first 6 months after the stroke. This affects approximately 46% of patients. But also
      cognitive processes, such as attention and concentration. Therefore, the treatment must be
      adapted to the respective strategy of the patient. If the patient increasingly uses the
      visual system, the therapy has to work a lot with the eyes closed. In turn, if he uses more
      of the sensorimotor system is increasingly trained with unstable documents. After this
      system, the balance program was set up. It is the same for the intervention and control group
      to make a difference between individual and group training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There will be a intervention group and a control group. Both groups do active treatment. In the intervention group they will have individual balance training and in the control group they will have balance training in a group from 3-6 persons. But both groups will do the same balance program.
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the walking speed at three weeks
time frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion
description: 10m walking test
measure: Change of the balance score at three weeks
time frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion
description: The Berg Balance Scale is used to determine the risk of falling. The BBS detects deficits at both activity and body function levels. It consists of 14 items. Some items require that the patient maintains positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Scaling takes place from 0 points (not possible) to 4 points (independently possible). This results in a total score of 56 points. The cut-off is at 45 points.
measure: Change of the Walking ability (walking aid) at three weeks
time frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion
description: Functional Ambulation categories - is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
arm group label: individual balance training
arm group type: Experimental
description: After the initial assessments, the three week intervention time begins, which is completed with the reassessments.
The patients receive 2x weekly individual balance training for 25 minutes each. This runs in addition to the normal, prescribed rehabilitation program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.
arm group label: group balance training
arm group type: Active Comparator
description: The patients receive 2x weekly group balance training for 25 minutes each. This runs in addition to the normal, prescribed rehab program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.
In group therapy are 3 to 6 patients with different neurological diagnoses. As it is usual in rehabilitation everyday life.
intervention type: Other
intervention name: individual balance training
description: One physiotherapist trains one Patient nearby a bar. The tasks changes in gage, visual feedback, vestibular feedback and underground. The Positions will be hodl for 10-30 seconds.
arm group label: individual balance training
intervention type: Other
intervention name: group balance training
description: Like the individual balance training
arm group label: group balance training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yvonne Teuschl, Ass.-Prof.
role: Study Chair
affiliation: Donauuniversität Krems (Danube University)
facility: 
country: Switzerland
url: http://www.rehaclinic.ch
description: RehaClinic AG
responsible party type: Principal Investigator
investigator affiliation: RehaClinic AG
investigator full name: Mrs. Wiebke Weigert
investigator title: Principal investigator
mesh term: Stroke
sharing ipd: No
provided document: 
provided document: 