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

Healthy Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758846
• Other study ID #: 2012-0111
• Secondary ID: 2P30AG022849-11
• Status: Completed
• Phase: N/A
• Start date: December 4, 2014
• Est. completion date: October 25, 2016

Study information

• Verified date: November 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Exclusion Criteria:

• 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

Inclusion/Exclusion criteria for Older adults

Inclusion Criteria:

• Participants should be 50 to 90 years of age.

• Able to follow instructions provided in English.

• 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).

Exclusion Criteria:

• 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.

• 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).

Related Conditions & MeSH terms

• Chronic Stroke
• Healthy Aging

Intervention

Behavioral:
• Cognitive-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.
• Conventional 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 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.
• Dance 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.
• Home education for Older adults
Participants will receive a one-hour education on conventional physical exercises.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Movement Velocity (during dual-tasking)	Degrees of movement per second of a self-initiated movement. Higher values indicate better performance.	Baseline (Week 0) and Immediate Post-training (Week 7)
Primary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Primary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Primary	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.	Baseline (Week 0) to Post-training (Week 7)
Primary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	Change in distance covered in Six minute walk test	Assess endurance and walking ability. Total walking distance covered in 6 minutes was recorded.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)
Secondary	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.	Baseline (Week 0) and Immediate Post-training (Week 7)