Chronic StrokeNCT03758846
Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
A study testing Cognitive-motor exergaming, Conventional balance Training and Dance Therapy for Stroke in people with Chronic Stroke and Healthy Aging, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke, Healthy Aging
- What is being tested?
- Cognitive-motor exergaming, Conventional balance Training and Dance Therapy for Stroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2014to 25 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be 18 to 90 years of age.
- Presence of Chronic stroke (onset of stroke more than six months) confirmed by a physician
- Ability to stand independently for 5 minutes without an assistive device or any physical assistance
- Ability to understand English
- Participants should be 50 to 90 years of age.
- Able to follow instructions provided in English.
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- No history of neurological impairment (Stroke, Parkinson's disease and Multiple Sclerosis).
- Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
- Cognitive skills to actively participate (score of < 26 on Montreal cognitive assessment indicates cognitive impairment).
Who cannot join
- A Score of less than 25 on Mini-mental state examination
- Heel bone density with T-score less than <-2.0
- Self-reported metal implants due to any orthopedic conditions
- Presence of any other neurological impairments such as Parkinsons disease, Alzheimers disease, vestibular dysfunction, peripheral neuropathy or unstable epilepsy
- Significant cognitive or communicative impairment indicated by a score of > 26 on Montreal cognitive assessment indicates cognitive impairment.
- In neurologically impaired individuals, for cognitive impairment a score of <25 on Mini Mental State Exam Score; for aphasia <71% on Mississippi Aphasia Screening Test and >15 on Geriatric Depression Scale.
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- Heel bone density with T-score less than <-2.0
- Participants unavailable for 6 weeks of participation.
- Uncontrolled pain >3/10 on VAS. Complains of shortness of breath.
- Uncontrolled hypertension (systolic blood pressure (SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg during resting).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Comparing Conventional and Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
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.
Read the detailed description
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:
- The efficacy of cognitive-motor exergaming (with Wii-fit) compared to conventional balance training among people with chronic stroke
- Exergaming (with Kinect) on domains of balance control and cognition among people with chronic stroke
- 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.
- Conditions
- Chronic Stroke, Healthy Aging
- Being tested
- Cognitive-motor exergaming, Conventional balance Training, Dance Therapy for Stroke, Dance Therapy for Older adults, Home education for Older adults
- Keywords
- Dual-task training, Cognitive-motor training, Conventional training, Virtual-reality exergaming, Dance Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-motor exergamingBehavioural
Also called Dual-task training, Wii-fit exergaming, Virtual-reality training
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.
Conventional balance TrainingBehavioural
Also called Balance training
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.
Dance Therapy for StrokeBehavioural
Also called Exergaming-based dance
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.
Dance Therapy for Older adultsBehavioural
Also called Exergaming-based dance
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.
Home education for Older adultsBehavioural
Also called Fall prevention
Participants will receive a one-hour education on conventional physical exercises.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-motor Exergaming | Experimental | 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. Receives: Behavioral: Cognitive-motor exergaming |
| Conventional balance Training for people with Chronic stroke | Active comparator | 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. Receives: Behavioral: Conventional balance Training |
| Dance Therapy for Stroke | Experimental | 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. Receives: Behavioral: Dance Therapy for Stroke |
| Dance Therapy for Older Adults | Experimental | 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. Receives: Behavioral: Dance Therapy for Older adults |
| Conventional therapy - Home education for Older adults | Active comparator | Participants received a one-hour education on conventional physical exercises and fall prevention. Receives: Behavioral: Home education for Older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Velocity (during dual-tasking)
Degrees of movement per second of a self-initiated movement. Higher values indicate better performance.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in Postural Stability (during single and dual-tasking)
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change Cognitive Accuracy (during dual-tasking)
Accuracy (number of correct responses out of the total responses) during the letter number sequencing task. Higher accuracy indicates better performance.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Compliance to therapy (total time spent over the intervention duration)
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.
Measured: Baseline (Week 0) to Post-training (Week 7)
Change in reaction time with functional arm reach - Dance therapy for people with stroke and healthy older adults
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary outcomes (7)
Change in Berg Balance Scale
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in distance covered in Six minute walk test
Assess endurance and walking ability. Total walking distance covered in 6 minutes was recorded.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in performance on Chair Stand Test
Assess balance, functional mobility and strength. It is the number of times the participant completed sit to stand within 30 seconds.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in performance on Four Step Square test
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in Activity Specific Balance confidence
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in physical activity
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.
Measured: Baseline (Week 0) and Immediate Post-training (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start4 Dec 2014
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois Chicago
- Investigators
- Tanvi S Bhatt, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758846
- Sponsor's protocol ID
- 2012-0111
- Other IDs
- 2P30AG022849-11
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2018
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Conventional and Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function
- ClinicalTrials.gov ID
- NCT03758846
- Acronym / sponsor ID
- 2012-0111
- Conditions
- Chronic Stroke, Healthy Aging
- Keywords
- Dual-task training, Cognitive-motor training, Conventional training, Virtual-reality exergaming, Dance Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- The efficacy of cognitive-motor exergaming (with Wii-fit) compared to conventional balance training among people with chronic stroke
- Exergaming (with Kinect) on domains of balance control and cognition among people with chronic stroke
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cognitive-motor Exergaming | Experimental | Behavioral: Cognitive-motor exergamingA 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. |
| Conventional balance Training for people with Chronic stroke | Active comparator | Behavioral: Conventional balance TrainingThe 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. |
| Dance Therapy for Stroke | Experimental | Behavioral: Dance Therapy for StrokeVirtual-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. |
| Dance Therapy for Older Adults | Experimental | Behavioral: Dance Therapy for Older adultsVirtual-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. |
| Conventional therapy - Home education for Older adults | Active comparator | Behavioral: Home education for Older adultsParticipants received a one-hour education on conventional physical exercises and fall prevention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants should be 18 to 90 years of age.
- Presence of Chronic stroke (onset of stroke more than six months) confirmed by a physician
- Ability to stand independently for 5 minutes without an assistive device or any physical assistance
- Ability to understand English
- Participants should be 50 to 90 years of age.
Key exclusion criteria (10 listed)
- A Score of less than 25 on Mini-mental state examination
- Heel bone density with T-score less than <-2.0
- Self-reported metal implants due to any orthopedic conditions
- Presence of any other neurological impairments such as Parkinsons disease, Alzheimers disease, vestibular dysfunction, peripheral neuropathy or unstable epilepsy
- Significant cognitive or communicative impairment indicated by a score of > 26 on Montreal cognitive assessment indicates cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-motor exergamingAlso: Dual-task training, Wii-fit exergaming, Virtual-reality trainingParticipants 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. | Behavioural | Cognitive-motor Exergaming |
| Conventional balance TrainingAlso: Balance trainingParticipants 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. | Behavioural | Conventional balance Training for people with Chronic stroke |
| Dance Therapy for StrokeAlso: Exergaming-based danceParticipants 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. | Behavioural | Dance Therapy for Stroke |
| Dance Therapy for Older adultsAlso: Exergaming-based danceParticipants 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. | Behavioural | Dance Therapy for Older Adults |
| Home education for Older adultsAlso: Fall preventionParticipants will receive a one-hour education on conventional physical exercises. | Behavioural | Conventional therapy - Home education for Older adults |
Primary outcome
Change in Movement Velocity (during dual-tasking)
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Degrees of movement per second of a self-initiated movement. Higher values indicate better performance.
Change in Postural Stability (during single and dual-tasking)
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
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.
Change Cognitive Accuracy (during dual-tasking)
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Accuracy (number of correct responses out of the total responses) during the letter number sequencing task. Higher accuracy indicates better performance.
Compliance to therapy (total time spent over the intervention duration)
Time frame: Baseline (Week 0) to Post-training (Week 7)
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.
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)
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.
7 secondary outcomes
Change in Berg Balance Scale
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
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)
Change in distance covered in Six minute walk test
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in performance on Chair Stand Test
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in performance on Four Step Square test
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in Activity Specific Balance confidence
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Change in physical activity
Time frame: Baseline (Week 0) and Immediate Post-training (Week 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanvi S Bhatt, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-motor exergaming, Conventional balance Training and Dance Therapy for Stroke in people with Chronic Stroke and Healthy Aging, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Velocity (during dual-tasking) (time frame: Baseline (Week 0) and Immediate Post-training (Week 7)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.