<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/NCT04460794</url>
  </required_header>
  <id_info>
    <org_study_id>FBB</org_study_id>
    <nct_id>NCT04460794</nct_id>
  </id_info>
  <brief_title>A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults With Stroke</brief_title>
  <official_title>Feasibility of a Novel Ballet-inspired Low-impact At-home Workout Programme to Improve Balance, Gait and Memory in Adults With Stroke: A Mixed Methods Exploratory Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the feasibility of a novel ballet-inspired low-impact at-home workout programme&#xD;
      for community-dwelling stroke survivors in Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A mixed methods exploratory study incorporating a randomised controlled trial (RCT) and&#xD;
      qualitative evaluation will be conducted. A total of 40 stroke participants will be recruited&#xD;
      from two acute public hospitals. Participants will be randomly assigned to receive the&#xD;
      interention and usual care, or usual care only. Data will be collected in multiple forms:&#xD;
      recruitment/retention rates, adherence to the intervention, journals, field notes, verbal&#xD;
      feedback, audio records, semi-structured interviews, and questionnaires on outcomes (balance,&#xD;
      confidence in balance, gait, walking endurance). This study is the first of its kind in Hong&#xD;
      Kong. Findings will address the cross-cultural applicability of dance interventions and lay&#xD;
      the groundwork for examination in a larger-RCT about its effects on survivors' balance, gait&#xD;
      and memory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2023</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the participants' level of balance</measure>
    <time_frame>Change from baseline to immediately after completion of the intervention (over 8 weeks)</time_frame>
    <description>The 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used. It measures four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait. Items are rated on a 3-level scale (0=&quot;Severe&quot;, 1=&quot;Moderate&quot;, 2=&quot;Normal&quot;). Summed total score=0-28 (higher scores representing better balance ability). Cronbach alpha=0.89-0.94.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the participants' level of balance confidence</measure>
    <time_frame>Change from baseline to immediately after completion of the intervention (over 8 weeks)</time_frame>
    <description>The 16-item Activities-specific Balance Confidence Scale (Chinese version) will be adopted. Participants will rate their confidence in balance associated with performing 16 daily functional activities from 0% (absolutely no confidence) to 100% (fully confident). Summed total score=0-100% (higher scores denotes higher confidence). Cronbach alpha=0.97.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the participants' level of gait</measure>
    <time_frame>Change from baseline to immediately after completion of the intervention (over 8 weeks)</time_frame>
    <description>The 31-item Gait Assessment and Intervention tool (G.A.I.T.) will be used to measure gait: upper extremity and trunk movement control; trunk and lower extremity (stance phase); trunk and lower extremity (swing phase). Each item is scored from 0 (normal) to 3, with gradients of variation from normal (Total score: 0 (normal gait) to 62 (greatest extent of gait deviations)). It has good intra-rater and interrater reliability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in participants' level of walking endurance</measure>
    <time_frame>Change from baseline to immediately after completion of the intervention (over 8 weeks)</time_frame>
    <description>The 6-Minute Walk Test (MWT) will be performed in accordance with American Thoracic Society guidelines. The distance walked, the time stopped and reason(s) for stopping prematurely will be recorded. 6MWT, 12MWT, and self-paced gait speed were all significantly highly correlated (r&gt;0.90).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in participants' level of memory</measure>
    <time_frame>Change from baseline to immediately after completion of the intervention (over 8 weeks)</time_frame>
    <description>The 11-item Rivermead Behavioural Memory Test - Third Version (Chinese version) will be used. For each task, scores range from 0-2 (2-points=normal; 1-point=intermediate; 0-point=error). Total score=0-254. It demonstrated a high inter-rater reliability. Correlation between performance on parallel forms=0.67-0.84.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <condition>Gait, Unsteady</condition>
  <condition>Balance; Distorted</condition>
  <condition>Memory Impairment</condition>
  <arm_group>
    <arm_group_label>Ballet-inspired workout programme (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will continue their usual activities and exercises, and in addition, receive an 8-week home-based programme delivered by trained volunteers via hybrid on-site and virtual contacts, and supported by volunteer healthcare professionals. A self-directed resource package will be developed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care (Group B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control participants will continue their usual activities and exercises during the study period. In addition, they will be provided with an information sheet about recommendations with pictorial demonstrations on basic stretching and leg exercises for stroke survivors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ballet-inspired workouts</intervention_name>
    <description>8 weeks, delivered by volunteers with a self-directed resource package</description>
    <arm_group_label>Ballet-inspired workout programme (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care and general recommendations on basic stretching and leg exercises for stroke survivors</description>
    <arm_group_label>Usual care (Group B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 18 years or above&#xD;
&#xD;
          2. clinically diagnosed with a first-ever ischaemic/ haemorrhagic stroke&#xD;
&#xD;
          3. living in home settings&#xD;
&#xD;
          4. mild-moderate lower limb paresis with a modified Functional Ambulation Classification&#xD;
             (MFAC) of III (Dependent walker) or above&#xD;
&#xD;
          5. a Montreal Cognitive Assessment (MoCA) score&gt;20&#xD;
&#xD;
          6. able to follow three-step directions&#xD;
&#xD;
          7. able to communicate in Cantonese and read Traditional Chinese&#xD;
&#xD;
          8. their hearing and/or visual disturbances corrected by hearing aids and/or glasses&#xD;
&#xD;
          9. consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diagnosed with transcient ischaemic attack, subdural or epidural haemorrhage&#xD;
&#xD;
          2. experienced cerebrovascular events due to tumours or head trauma&#xD;
&#xD;
          3. have pre-existing neurological, cardiovascular or orthopaedic conditions that&#xD;
             contradict participation in dancing such as shoulder dislocation, myocardial&#xD;
             infarction, seizures or acutes illness&#xD;
&#xD;
          4. mental condition such as depression, schizophrenia or personality disorder&#xD;
&#xD;
          5. incomprehensible speech&#xD;
&#xD;
          6. severe hearing and/or visual disturbance&#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>Suzanne Lo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suzanne Lo</last_name>
    <phone>852 39434485</phone>
    <email>suzannelo@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alice Ho Miu Ling Nethersole Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzanne Lo</last_name>
      <phone>85239434485</phone>
      <email>suzannelo@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Suzanne HS Lo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request, for six years upon completion of the study.</ipd_time_frame>
    <ipd_access_criteria>The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.</ipd_access_criteria>
  </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/NCT04460794
org study id: FBB
nct id: NCT04460794
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To explore the feasibility of a novel ballet-inspired low-impact at-home workout programme
      for community-dwelling stroke survivors in Hong Kong.
A mixed methods exploratory study incorporating a randomised controlled trial (RCT) and
      qualitative evaluation will be conducted. A total of 40 stroke participants will be recruited
      from two acute public hospitals. Participants will be randomly assigned to receive the
      interention and usual care, or usual care only. Data will be collected in multiple forms:
      recruitment/retention rates, adherence to the intervention, journals, field notes, verbal
      feedback, audio records, semi-structured interviews, and questionnaires on outcomes (balance,
      confidence in balance, gait, walking endurance). This study is the first of its kind in Hong
      Kong. Findings will address the cross-cultural applicability of dance interventions and lay
      the groundwork for examination in a larger-RCT about its effects on survivors' balance, gait
      and memory.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in the participants' level of balance
time frame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
description: The 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used. It measures four domains: anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait. Items are rated on a 3-level scale (0="Severe", 1="Moderate", 2="Normal"). Summed total score=0-28 (higher scores representing better balance ability). Cronbach alpha=0.89-0.94.
measure: Change in the participants' level of balance confidence
time frame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
description: The 16-item Activities-specific Balance Confidence Scale (Chinese version) will be adopted. Participants will rate their confidence in balance associated with performing 16 daily functional activities from 0% (absolutely no confidence) to 100% (fully confident). Summed total score=0-100% (higher scores denotes higher confidence). Cronbach alpha=0.97.
measure: Change in the participants' level of gait
time frame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
description: The 31-item Gait Assessment and Intervention tool (G.A.I.T.) will be used to measure gait: upper extremity and trunk movement control; trunk and lower extremity (stance phase); trunk and lower extremity (swing phase). Each item is scored from 0 (normal) to 3, with gradients of variation from normal (Total score: 0 (normal gait) to 62 (greatest extent of gait deviations)). It has good intra-rater and interrater reliability.
measure: Change in participants' level of walking endurance
time frame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
description: The 6-Minute Walk Test (MWT) will be performed in accordance with American Thoracic Society guidelines. The distance walked, the time stopped and reason(s) for stopping prematurely will be recorded. 6MWT, 12MWT, and self-paced gait speed were all significantly highly correlated (r>0.90).
measure: Change in participants' level of memory
time frame: Change from baseline to immediately after completion of the intervention (over 8 weeks)
description: The 11-item Rivermead Behavioural Memory Test - Third Version (Chinese version) will be used. For each task, scores range from 0-2 (2-points=normal; 1-point=intermediate; 0-point=error). Total score=0-254. It demonstrated a high inter-rater reliability. Correlation between performance on parallel forms=0.67-0.84.
arm group label: Ballet-inspired workout programme (Group A)
arm group type: Experimental
description: Participants will continue their usual activities and exercises, and in addition, receive an 8-week home-based programme delivered by trained volunteers via hybrid on-site and virtual contacts, and supported by volunteer healthcare professionals. A self-directed resource package will be developed.
arm group label: Usual care (Group B)
arm group type: Other
description: Control participants will continue their usual activities and exercises during the study period. In addition, they will be provided with an information sheet about recommendations with pictorial demonstrations on basic stretching and leg exercises for stroke survivors.
intervention type: Behavioral
intervention name: Ballet-inspired workouts
description: 8 weeks, delivered by volunteers with a self-directed resource package
arm group label: Ballet-inspired workout programme (Group A)
intervention type: Other
intervention name: Usual care
description: Usual care and general recommendations on basic stretching and leg exercises for stroke survivors
arm group label: Usual care (Group B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne Lo
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Suzanne Lo
phone: 852 39434485
email: suzannelo@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Suzanne HS Lo
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Gait Disorders, Neurologic
sharing ipd: Yes
ipd description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd time frame: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request, for six years upon completion of the study.
ipd access criteria: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.