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

University of Illinois

Status: Completed

Conditions: Chronic Stroke; Healthy Aging

Treatments: Behavioral: Cognitive-motor exergaming; Behavioral: Conventional balance Training; Behavioral: Dance Therapy for Older adults; Behavioral: Home education for Older adults; Behavioral: Dance Therapy for Stroke

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03758846

2012-0111

2P30AG022849-11 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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65 participants in 5 patient groups

Cognitive-motor Exergaming

Experimental group

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.

Treatment:

Behavioral: Cognitive-motor exergaming

Conventional balance Training for people with Chronic stroke

Active Comparator group

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.

Treatment:

Behavioral: Conventional balance Training

Dance Therapy for Stroke

Experimental group

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.

Treatment:

Behavioral: Dance Therapy for Stroke

Dance Therapy for Older Adults

Experimental group

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.

Treatment:

Behavioral: Dance Therapy for Older adults

Conventional therapy - Home education for Older adults

Active Comparator group

Description:

Participants received a one-hour education on conventional physical exercises and fall prevention.

Treatment:

Behavioral: Home education for Older adults