Alternative Therapies for Improving Physical Function in Individuals With Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2025-09-30

Brief Summary

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Neurological impairment is a devastating disease for patients and their families and a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. However, health care reimbursed rehabilitation is usually provided for up to 6 months post stroke (3 months in form of inpatient therapy and 3 months in outpatient therapy). There are increasing community and other facilities offering rehabilitation in form of conventional, recreational and alternative (Yoga, Tai-chi) therapy. However, implementation of these conventional therapy techniques in individuals with neurological disorder impairments 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 dance and gaming based virtual dance and gaming based therapy to improve overall physical function of community-dwelling individuals with neurological impairments, 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 an alternative dance and gaming-based virtual gaming therapy to improve overall physical function of community-dwelling individuals with neurologically impairment and compare it to that of conventional rehabilitation and also to determine the gains in community participation and integration with longer-term compliance to the dance and gaming -based intervention.

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Detailed Description

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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. Aim 1: To determine the efficacy of an alternative dance and gaming based cognitive-motor virtual reality therapy to that of a conventional rehabilitation in a clinical setting to improve physical and cognitive function of healthy adults and neurologically impaired community-dwelling individuals under both short duration high intensity and long duration intervention paradigm. The primary safety outcome would be the proportion of patients experiencing intervention-related adverse events during the study period. The primary feasibility outcome would be the total time receiving intervention (i.e. compliance). Motivation index found to correlate highly with compliance will be evaluated by the self-report Intrinsic Motivational Inventory and serve as the secondary factor. The primary efficacy outcome measures to determine improvements in physical function would incorporate main domains: Sensorimotor impairment and function (upper and lower extremity), balance control and fall-risk, cognition, cardiovascular function, and community participation and integration administered pre and post intervention (details in methods). Hypothesis 1: Investigators hypothesize that alternative dance and gaming based cognitive-motor virtual reality therapy and perturbation training would show greater efficacy through improvement in main domains of physical function (sensorimotor, balance control, cognition, fall-risk, and cardiovascular function) compared to the conventional balance training. Aim 2: To determine the compliance and gains in community participation and integration following gaming based virtual reality intervention. Hypothesis 2: With same number of sessions of both types of training, investigators hypothesize that virtual reality based interventions would show better compliance to therapy through better score on Intrinsic Motivational Inventory (IMI) than the conventional therapy. Higher IMI scores in this virtual reality intervention group will be positively correlated with the improvements in quality of life (Motor Activity Log), Community integration (CIQ) and Fall-risk reduction (Falls Efficacy and Activities-specific balance confidence scales).

Aim 3: To compare the compliance and effect of a short duration high intensity training (20 sessions over 6 weeks) with a low intensity longer duration (36 sessions over 12 weeks) balance training for the two types of interventions. Hypothesis 3: It is hypothesized that for both types of interventions, short duration high intensity training will be as effective for improvement in physical function as longer duration low intensity training. However, the compliance of short duration training would be greater (higher IMI score) compared to the longer duration training.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention provider and assessor were all blinded

Study Groups

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Virtual-reality based dance group

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.

Group Type EXPERIMENTAL

Virtual-reality based dance training

Intervention Type 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.

Interventions

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Virtual-reality based dance training

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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VR-based dance, exergaming-based dance

Eligibility Criteria

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Inclusion Criteria

1. Participants should be 18 to 90 years of age.
2. Able to follow instructions provided in English.
3. History of neurological impairment (Stroke, Parkinson's disease and Multiple Sclerosis) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
4. Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
5. Cognitive skills to actively participate (score of \< 26 on Montreal cognitive assessment indicates cognitive impairment) (30).
6. Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of \> or = 2/5).
7. Parkinson's disease a) - Stable medication use b) stage I or II of the Boher classification of Parkinson's disease c) No sudden fluctuations (on-off phenomenon).
8. Multiple Sclerosis - No Severe disability "Expanded Disability Status Scale" (EDSS scale \< or = 4.5).

Exclusion Criteria

* 1\. 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.

2\. Presence of concurrent severe medical illness, including unhealed pressure sores, active or untreated infection, thromboembolic disease, severe contractures, active heterotrophic ossification in the lower extremities, lower limb fractures, known history of peripheral nerve injury in the lower legs, history of cardiovascular or pulmonary complications, or with pacemakers and history of metabolic (endocrine, hepatic) or renal dysfunction, uncontrolled seizures (Self-report).

3\. History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (\<6months) or hospitalization (\<3months) and on any sedative drugs.

4\. Partcipants unavailable for 12 weeks of participation, 5. Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.

6\. Pregnancy. 7. Uncontrolled pain \>3/10 on VAS 8. Complains of shortness of breath 9. Uncontrolled hypertension (systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting) \[1,2\].

10\. Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) \[3\].

11\. Oxygen saturation (measured by pulse oximeter) during resting \< 95%. 12. Severe cardiac disease (New York Heart Association classification of II-IV) \[1\].

ii. Partcipants with \> 250 lbs in weight or with a BMI OF \>35Kg/m2. It should be noted that the harness system is capable of tolerating up to 300 lbs of weight safely.

iii. Unable to walk a length of 8 meters without cane two times with a rest break in between the two walks, lasting shorter than five minutes.

iv. Unable to stand for at least 5 minutes (to accommodate length of a dance song) as assessed by decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic measured by the a research team member.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes