<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/NCT03758846</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0111</org_study_id>
    <secondary_id>2P30AG022849-11</secondary_id>
    <nct_id>NCT03758846</nct_id>
  </id_info>
  <brief_title>Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function</brief_title>
  <official_title>Comparing Conventional and Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      Neurological impairment such as stroke and aging is a leading cause of adult disability.&#xD;
      Traditional rehabilitative therapies can help regain motor function and ameliorate&#xD;
      disability. There are increasing community and other facilities offering rehabilitation in&#xD;
      the form of conventional, recreational and alternative (Yoga, Tai-chi) therapy. However, the&#xD;
      implementation of these conventional therapy techniques in individuals with a neurological&#xD;
      disorder like stroke and the elderly population is tedious, resource-intensive, and costly,&#xD;
      often requiring transportation of patients to specialized facilities. Based on recent&#xD;
      evidence suggesting significant benefits of repetitive, task-orientated training,&#xD;
      investigators propose to evaluate the feasibility of an alternative therapies such as&#xD;
      exergaming based therapy to improve overall physical function of community-dwelling&#xD;
      individuals with neurological impairments and the elderly, compared to conventional&#xD;
      therapeutic rehabilitation. This pilot study aims to systematically obtain pilot data on&#xD;
      compliance and efficacy as well as performing power analysis and sample size calculation for&#xD;
      developing it into a randomized controlled trial for extramural funding purposes. The&#xD;
      objective of the study is to determine the safety, feasibility, compliance and efficacy of&#xD;
      exergaming therapy to improve overall physical function of community-dwelling chronic stroke&#xD;
      individuals and the elderly population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While conventional balance training facilitates balance control and gait functions, the&#xD;
      exercises involved in the training are labor-intensive, highly repetitious leading to&#xD;
      monotonicity and decreased motivation levels. Therefore, many health care researchers are&#xD;
      involved in identifying various methods to reduce the risk of falls addressing the barriers&#xD;
      in conventional training methods while having the potential to translate it at home. A pilot&#xD;
      study identified that supplementary cognitive training along with Wii-fit balance training&#xD;
      resulted in improving dual-task volitional balance control post-stroke. Based on this&#xD;
      preliminary finding, this current pilot study aimed to identify:&#xD;
&#xD;
        1. The efficacy of cognitive-motor exergaming (with Wii-fit) compared to conventional&#xD;
           balance training among people with chronic stroke&#xD;
&#xD;
        2. Exergaming (with Kinect) on domains of balance control and cognition among people with&#xD;
           chronic stroke&#xD;
&#xD;
        3. The efficacy of Exergaming (with Kinect) compared to conventional balance training&#xD;
           method on domains of balance control and cognition among healthy older adults&#xD;
&#xD;
      This pilot study used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially&#xD;
      available and a cost-effective device that provides similar benefits of exergaming.&#xD;
      Community-dwelling people with chronic stroke and healthy older adults involved in the study&#xD;
      underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a&#xD;
      laboratory setting. Participants were assessed for motor and cognitive performance in the&#xD;
      laboratory during volitional and reactive balance control while performing a secondary&#xD;
      cognitive task. The performance outcome determined the effect on cognitive-motor interference&#xD;
      during dual-tasking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2014</start_date>
  <completion_date type="Actual">October 25, 2016</completion_date>
  <primary_completion_date type="Actual">October 25, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Movement Velocity (during dual-tasking)</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Degrees of movement per second of a self-initiated movement. Higher values indicate better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Postural Stability (during single and dual-tasking)</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Postural Stability (Laboratory Slip test) can be defined by simultaneous control of center of mass (COM) position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Cognitive Accuracy (during dual-tasking)</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Accuracy (number of correct responses out of the total responses) during the letter number sequencing task. Higher accuracy indicates better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance to therapy (total time spent over the intervention duration)</measure>
    <time_frame>Baseline (Week 0) to Post-training (Week 7)</time_frame>
    <description>Compliance will be assessed by logs of participation time (total time summed over the intervention duration). This will assess if participants were able to complete and tolerate the intervention. Higher values indicate more compliance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in reaction time with functional arm reach - Dance therapy for people with stroke and healthy older adults</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Reaction time was evaluated with electromyography as the time elapsed between the final cue, &quot;Go&quot; (at 4s), and the onset of EMG signal (calculated as ±1 standard deviation from baseline). Electromyographic will be used to monitor muscle activity in both upper extremities for stand arm reaching. The test will take about 30 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Berg Balance Scale</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Assess static and dynamic balance control. It is a 14 item scale. Score for each item ranges from 0-4. Item score are then summed and maximum score of 54 can be obtained. Less than 45 on this scale indicates a greater risk for falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Assess mobility, balance and walking ability. It is a fall risk predictor. More than 14 seconds taken to complete the test indicates a greater risk for falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in distance covered in Six minute walk test</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Assess endurance and walking ability. Total walking distance covered in 6 minutes was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on Chair Stand Test</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Assess balance, functional mobility and strength. It is the number of times the participant completed sit to stand within 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on Four Step Square test</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>Assess balance. The amount of time taken (in seconds) for the participant to complete the sequence of stepping was recorded. More than 15 seconds to complete the test indicates greater risk of falling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activity Specific Balance confidence</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>It is a 16 item self-reported physical activity and community integration questionnaire with each item score ranging from 0-100, where 0 indicates no confidence and 100 indicates complete confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>Baseline (Week 0) and Immediate Post-training (Week 7)</time_frame>
    <description>For this purpose, the number of steps taken for up to one week will be measured using a wearable sensor by Tractivity (Huston, Texas). During the initial visit, participant will be given the sensor placed in an ankle band. After initial activity monitoring for one week, participants will be scheduled for the training session. After the training participants post-training one-week physical activity will also be monitored. Higher number of steps, indicate more physical activity.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Chronic Stroke</condition>
  <condition>Healthy Aging</condition>
  <arm_group>
    <arm_group_label>Cognitive-motor Exergaming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 6 Wii-fit games: Bubble balance, Table Tilt, Tightrope walking, Soccer head, Basic Run and Basic Step. A total of 6 cognitive tasks namely Digit recall, repeated letter, word list generation (category and alphabets), mental arithmetic, analogies. Each session was divided into 3 sub-sessions. Every Wii-fit game was played with any 3 cognitive tasks. The combination of games with cognitive tasks was randomized in such a manner that all the cognitive tasks were played with the Wii-fit games in that session. Breaks were provided after each sub-session or when the participant demanded one or when the research personnel noticed any discomfort of the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional balance Training for people with Chronic stroke</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The sessions were divided into 10 minutes of warm-up that involved active movements of the body (arm movements, trunk twists, lunges). Next 15 minutes consisted of functional strengthening exercises like high stepping, lunges, squats, resistance training using therabands and weights. Following 35 minutes included balance training exercises like one leg standing, tandem standing, sit to stand exercises, reach outs and step-ups. Last 10-15 minutes were spent treadmill walking. Breaks were provided in between the exercise training as and when needed by the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dance Therapy for Stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual-reality based dance training - Participants received Virtual-reality based dance training for 6 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) &quot;Just Dance 3&quot;. The six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dance Therapy for Older Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual-reality based dance training - Participants received Virtual-reality based dance training for 6 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) &quot;Just Dance 3&quot;. The six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional therapy - Home education for Older adults</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received a one-hour education on conventional physical exercises and fall prevention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-motor exergaming</intervention_name>
    <description>Participants undergo 6 weeks of cognitive-motor exergaming using Wii-fit Nintendo. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.</description>
    <arm_group_label>Cognitive-motor Exergaming</arm_group_label>
    <other_name>Dual-task training</other_name>
    <other_name>Wii-fit exergaming</other_name>
    <other_name>Virtual-reality training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional balance Training</intervention_name>
    <description>Participants undergo 6 weeks of conventional exercise training. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.</description>
    <arm_group_label>Conventional balance Training for people with Chronic stroke</arm_group_label>
    <other_name>Balance training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dance Therapy for Stroke</intervention_name>
    <description>Participants will receive therapy using the &quot;Just Dance&quot; using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.</description>
    <arm_group_label>Dance Therapy for Stroke</arm_group_label>
    <other_name>Exergaming-based dance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dance Therapy for Older adults</intervention_name>
    <description>Participants will receive therapy using the &quot;Just Dance&quot; using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two therapists.</description>
    <arm_group_label>Dance Therapy for Older Adults</arm_group_label>
    <other_name>Exergaming-based dance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home education for Older adults</intervention_name>
    <description>Participants will receive a one-hour education on conventional physical exercises.</description>
    <arm_group_label>Conventional therapy - Home education for Older adults</arm_group_label>
    <other_name>Fall prevention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion/Exclusion criteria for Stroke&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants should be 18 to 90 years of age.&#xD;
&#xD;
          -  Presence of Chronic stroke (onset of stroke more than six months) confirmed by a&#xD;
             physician&#xD;
&#xD;
          -  Ability to stand independently for 5 minutes without an assistive device or any&#xD;
             physical assistance&#xD;
&#xD;
          -  Ability to understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A Score of less than 25 on Mini-mental state examination&#xD;
&#xD;
          -  Heel bone density with T-score less than &lt;-2.0&#xD;
&#xD;
          -  Self-reported metal implants due to any orthopedic conditions&#xD;
&#xD;
          -  Presence of any other neurological impairments such as Parkinsons disease, Alzheimers&#xD;
             disease, vestibular dysfunction, peripheral neuropathy or unstable epilepsy&#xD;
&#xD;
        Inclusion/Exclusion criteria for Older adults&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants should be 50 to 90 years of age.&#xD;
&#xD;
          -  Able to follow instructions provided in English.&#xD;
&#xD;
          -  No history of neurological impairment (Stroke, Parkinson's disease and Multiple&#xD;
             Sclerosis).&#xD;
&#xD;
          -  Able to stand and walk with or without assistive device or braces as part of their&#xD;
             activities of daily living (self-report).&#xD;
&#xD;
          -  Cognitive skills to actively participate (score of &lt; 26 on Montreal cognitive&#xD;
             assessment indicates cognitive impairment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cognitive or communicative impairment indicated by a score of &gt; 26 on&#xD;
             Montreal cognitive assessment indicates cognitive impairment.&#xD;
&#xD;
          -  In neurologically impaired individuals, for cognitive impairment a score of &lt;25 on&#xD;
             Mini Mental State Exam Score; for aphasia &lt;71% on Mississippi Aphasia Screening Test&#xD;
             and &gt;15 on Geriatric Depression Scale.&#xD;
&#xD;
          -  Heel bone density with T-score less than &lt;-2.0&#xD;
&#xD;
          -  Participants unavailable for 6 weeks of participation.&#xD;
&#xD;
          -  Uncontrolled pain &gt;3/10 on VAS. Complains of shortness of breath.&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure (SBP) &gt; 165 mmHg and/or diastolic&#xD;
             blood pressure (DBP) &gt; 110 mmHg during resting).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanvi S Bhatt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Tanvi Bhatt</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Dual-task training</keyword>
  <keyword>Cognitive-motor training</keyword>
  <keyword>Conventional training</keyword>
  <keyword>Virtual-reality exergaming</keyword>
  <keyword>Dance Therapy</keyword>
  <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/NCT03758846
org study id: 2012-0111
secondary id: 2P30AG022849-11
nct id: NCT03758846
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neurological impairment such as stroke and aging is a leading cause of adult disability.
      Traditional rehabilitative therapies can help regain motor function and ameliorate
      disability. There are increasing community and other facilities offering rehabilitation in
      the form of conventional, recreational and alternative (Yoga, Tai-chi) therapy. However, the
      implementation of these conventional therapy techniques in individuals with a neurological
      disorder like stroke and the elderly population is tedious, resource-intensive, and costly,
      often requiring transportation of patients to specialized facilities. Based on recent
      evidence suggesting significant benefits of repetitive, task-orientated training,
      investigators propose to evaluate the feasibility of an alternative therapies such as
      exergaming based therapy to improve overall physical function of community-dwelling
      individuals with neurological impairments and the elderly, compared to conventional
      therapeutic rehabilitation. This pilot study aims to systematically obtain pilot data on
      compliance and efficacy as well as performing power analysis and sample size calculation for
      developing it into a randomized controlled trial for extramural funding purposes. The
      objective of the study is to determine the safety, feasibility, compliance and efficacy of
      exergaming therapy to improve overall physical function of community-dwelling chronic stroke
      individuals and the elderly population.
While conventional balance training facilitates balance control and gait functions, the
      exercises involved in the training are labor-intensive, highly repetitious leading to
      monotonicity and decreased motivation levels. Therefore, many health care researchers are
      involved in identifying various methods to reduce the risk of falls addressing the barriers
      in conventional training methods while having the potential to translate it at home. A pilot
      study identified that supplementary cognitive training along with Wii-fit balance training
      resulted in improving dual-task volitional balance control post-stroke. Based on this
      preliminary finding, this current pilot study aimed to identify:

        1. The efficacy of cognitive-motor exergaming (with Wii-fit) compared to conventional
           balance training among people with chronic stroke

        2. Exergaming (with Kinect) on domains of balance control and cognition among people with
           chronic stroke

        3. The efficacy of Exergaming (with Kinect) compared to conventional balance training
           method on domains of balance control and cognition among healthy older adults

      This pilot study used Wii-fit Nintendo/ Microsoft Kinect, an off the shelf, commercially
      available and a cost-effective device that provides similar benefits of exergaming.
      Community-dwelling people with chronic stroke and healthy older adults involved in the study
      underwent 6 weeks of exergaming or conventional balance training in a tapering manner in a
      laboratory setting. Participants were assessed for motor and cognitive performance in the
      laboratory during volitional and reactive balance control while performing a secondary
      cognitive task. The performance outcome determined the effect on cognitive-motor interference
      during dual-tasking.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in Movement Velocity (during dual-tasking)
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Degrees of movement per second of a self-initiated movement. Higher values indicate better performance.
measure: Change in Postural Stability (during single and dual-tasking)
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Postural Stability (Laboratory Slip test) can be defined by simultaneous control of center of mass (COM) position and velocity during slip-like perturbation relative to the rear edge of base of support (rear heel). The position normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Greater values indicate greater stability.
measure: Change Cognitive Accuracy (during dual-tasking)
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Accuracy (number of correct responses out of the total responses) during the letter number sequencing task. Higher accuracy indicates better performance.
measure: Compliance to therapy (total time spent over the intervention duration)
time frame: Baseline (Week 0) to Post-training (Week 7)
description: Compliance will be assessed by logs of participation time (total time summed over the intervention duration). This will assess if participants were able to complete and tolerate the intervention. Higher values indicate more compliance.
measure: Change in reaction time with functional arm reach - Dance therapy for people with stroke and healthy older adults
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Reaction time was evaluated with electromyography as the time elapsed between the final cue, "Go" (at 4s), and the onset of EMG signal (calculated as ±1 standard deviation from baseline). Electromyographic will be used to monitor muscle activity in both upper extremities for stand arm reaching. The test will take about 30 minutes.
measure: Change in Berg Balance Scale
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Assess static and dynamic balance control. It is a 14 item scale. Score for each item ranges from 0-4. Item score are then summed and maximum score of 54 can be obtained. Less than 45 on this scale indicates a greater risk for falling.
measure: Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Assess mobility, balance and walking ability. It is a fall risk predictor. More than 14 seconds taken to complete the test indicates a greater risk for falling.
measure: Change in distance covered in Six minute walk test
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Assess endurance and walking ability. Total walking distance covered in 6 minutes was recorded.
measure: Change in performance on Chair Stand Test
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Assess balance, functional mobility and strength. It is the number of times the participant completed sit to stand within 30 seconds.
measure: Change in performance on Four Step Square test
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: Assess balance. The amount of time taken (in seconds) for the participant to complete the sequence of stepping was recorded. More than 15 seconds to complete the test indicates greater risk of falling.
measure: Change in Activity Specific Balance confidence
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: It is a 16 item self-reported physical activity and community integration questionnaire with each item score ranging from 0-100, where 0 indicates no confidence and 100 indicates complete confidence.
measure: Change in physical activity
time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
description: For this purpose, the number of steps taken for up to one week will be measured using a wearable sensor by Tractivity (Huston, Texas). During the initial visit, participant will be given the sensor placed in an ankle band. After initial activity monitoring for one week, participants will be scheduled for the training session. After the training participants post-training one-week physical activity will also be monitored. Higher number of steps, indicate more physical activity.
arm group label: Cognitive-motor Exergaming
arm group type: Experimental
description: A total of 6 Wii-fit games: Bubble balance, Table Tilt, Tightrope walking, Soccer head, Basic Run and Basic Step. A total of 6 cognitive tasks namely Digit recall, repeated letter, word list generation (category and alphabets), mental arithmetic, analogies. Each session was divided into 3 sub-sessions. Every Wii-fit game was played with any 3 cognitive tasks. The combination of games with cognitive tasks was randomized in such a manner that all the cognitive tasks were played with the Wii-fit games in that session. Breaks were provided after each sub-session or when the participant demanded one or when the research personnel noticed any discomfort of the participant.
arm group label: Conventional balance Training for people with Chronic stroke
arm group type: Active Comparator
description: The sessions were divided into 10 minutes of warm-up that involved active movements of the body (arm movements, trunk twists, lunges). Next 15 minutes consisted of functional strengthening exercises like high stepping, lunges, squats, resistance training using therabands and weights. Following 35 minutes included balance training exercises like one leg standing, tandem standing, sit to stand exercises, reach outs and step-ups. Last 10-15 minutes were spent treadmill walking. Breaks were provided in between the exercise training as and when needed by the participant.
arm group label: Dance Therapy for Stroke
arm group type: Experimental
description: Virtual-reality based dance training - Participants received Virtual-reality based dance training for 6 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song.
arm group label: Dance Therapy for Older Adults
arm group type: Experimental
description: Virtual-reality based dance training - Participants received Virtual-reality based dance training for 6 weeks using the commercially available Kinect dance game (Microsoft Inc., Redmond, WA, U.S.A.) "Just Dance 3". The six week session consisted of 5 sessions/week, next two weeks of 3 sessions/week and last two weeks of 2 sessions/week, for a total of 20 sessions. Participants played on 10 songs for the first 2 weeks, progressing to 12 songs during the 3nd and 4th weeks with an addition of 2 more songs of their choice during the last two weeks. Participants played on alternating slow- and fast-paced songs (each maximum of 4 minutes in duration) with a five minutes break after a set of one slow and fast song.
arm group label: Conventional therapy - Home education for Older adults
arm group type: Active Comparator
description: Participants received a one-hour education on conventional physical exercises and fall prevention.
intervention type: Behavioral
intervention name: Cognitive-motor exergaming
description: Participants undergo 6 weeks of cognitive-motor exergaming using Wii-fit Nintendo. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.
arm group label: Cognitive-motor Exergaming
other name: Dual-task training
other name: Wii-fit exergaming
other name: Virtual-reality training
intervention type: Behavioral
intervention name: Conventional balance Training
description: Participants undergo 6 weeks of conventional exercise training. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.
arm group label: Conventional balance Training for people with Chronic stroke
other name: Balance training
intervention type: Behavioral
intervention name: Dance Therapy for Stroke
description: Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists.
arm group label: Dance Therapy for Stroke
other name: Exergaming-based dance
intervention type: Behavioral
intervention name: Dance Therapy for Older adults
description: Participants will receive therapy using the "Just Dance" using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two therapists.
arm group label: Dance Therapy for Older Adults
other name: Exergaming-based dance
intervention type: Behavioral
intervention name: Home education for Older adults
description: Participants will receive a one-hour education on conventional physical exercises.
arm group label: Conventional therapy - Home education for Older adults
other name: Fall prevention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tanvi S Bhatt, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Tanvi Bhatt
investigator title: Associate Professor
sharing ipd: No