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Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function

Comparing Conventional and Alternative Therapies for Improving Motor Impairment, Fall-risk and Overall Physical Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758846
Enrollment
65
Registered
2018-11-29
Start date
2014-12-04
Completion date
2016-10-25
Last updated
2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke, Healthy Aging

Keywords

Dual-task training, Cognitive-motor training, Conventional training, Virtual-reality exergaming, Dance Therapy

Brief 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. 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: 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.

Interventions

BEHAVIORALCognitive-motor exergaming

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.

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.

BEHAVIORALDance Therapy for Stroke

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.

BEHAVIORALDance Therapy for Older adults

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.

BEHAVIORALHome education for Older adults

Participants will receive a one-hour education on conventional physical exercises.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion/

Exclusion criteria

for Stroke Inclusion Criteria: * 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Movement Velocity (during dual-tasking)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)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)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)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 adultsBaseline (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.

Secondary

MeasureTime frameDescription
Change in Activity Specific Balance confidenceBaseline (Week 0) and Immediate Post-training (Week 7)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.
Change in Berg Balance ScaleBaseline (Week 0) and Immediate Post-training (Week 7)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.
Change in physical activityBaseline (Week 0) and Immediate Post-training (Week 7)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.
Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)Baseline (Week 0) and Immediate Post-training (Week 7)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.
Change in distance covered in Six minute walk testBaseline (Week 0) and Immediate Post-training (Week 7)Assess endurance and walking ability. Total walking distance covered in 6 minutes was recorded.
Change in performance on Chair Stand TestBaseline (Week 0) and Immediate Post-training (Week 7)Assess balance, functional mobility and strength. It is the number of times the participant completed sit to stand within 30 seconds.
Change in performance on Four Step Square testBaseline (Week 0) and Immediate Post-training (Week 7)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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026