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

NCT03758846 | Completed

• 2 other identifiers: 2012-01112P30AG022849-11
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke; Healthy Aging

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• Change in Berg Balance Scale

  Baseline (Week 0) and Immediate Post-training (Week 7)

• Change in Timed Up and Go test and cognitive Timed up and Go test (seconds)

  Baseline (Week 0) and Immediate Post-training (Week 7)

• Change in distance covered in Six minute walk test

  Baseline (Week 0) and Immediate Post-training (Week 7)

• Change in performance on Chair Stand Test

  Baseline (Week 0) and Immediate Post-training (Week 7)

• Change in performance on Four Step Square test

  Baseline (Week 0) and Immediate Post-training (Week 7)

Study Arms (5)

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.

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.

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.

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.

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.

Behavioral: Home education for Older adults

Interventions

Cognitive-motor exergaming BEHAVIORAL

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.

Also known as: Dual-task training, Wii-fit exergaming, Virtual-reality training

Cognitive-motor Exergaming

Conventional balance Training BEHAVIORAL

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.

Also known as: Balance training

Conventional balance Training for people with Chronic stroke

Dance Therapy for Stroke BEHAVIORAL

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.

Also known as: Exergaming-based dance

Dance Therapy for Stroke

Dance Therapy for Older adults BEHAVIORAL

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.

Also known as: Exergaming-based dance

Dance Therapy for Older Adults

Home education for Older adults BEHAVIORAL

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

Also known as: Fall prevention

Conventional therapy - Home education for Older adults

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• 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).
• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Dance Therapy; Aging

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise Movement Techniques; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Growth and Development; Physiological Phenomena

Study Officials

• Tanvi S Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 29, 2018
• Study Start: December 4, 2014
• Primary Completion: October 25, 2016
• Study Completion: October 25, 2016
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)