Alternative Therapies for Improving Physical Function in Individuals With Stroke

NCT03869138 | Recruiting DMC

• 1 other identifier: 2019-0035
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Change in Postural Stability

  Postural Stability can be defined by simultaneous control of center of mass 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), Mid-training (2nd week), and Post-training (7th week)

• 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), Mid-training (2nd week), and Post-training (7th week)

• Change in reaction time with functional arm reach

  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), Mid-training (2nd week), and Post-training (7th week)

Secondary Outcomes (3)

• Change in Movement Velocity

  Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)

• Change in physical activity

  Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)

• Change in Berg Balance Scale

  Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)

Study Arms (1)

Virtual-reality based dance group

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: Virtual-reality based dance training

Interventions

Virtual-reality based dance training 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: VR-based dance,, exergaming-based dance

Virtual-reality based dance group

Eligibility Criteria

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

You may qualify if:

• Participants should be 18 to 90 years of age.
• Able to follow instructions provided in English.
• 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).
• 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) (30).
• 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).
• 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).
• Multiple Sclerosis - No Severe disability "Expanded Disability Status Scale" (EDSS scale \< or = 4.5).

You may not qualify if:

• \. 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.
• \. 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).
• \. 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.
• \. 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.
• \. 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) \[1,2\].
• \. Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) \[3\].
• \. 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

SUSPENDED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tanvi Bhatt

  University of Illinois Chicago

  STUDY DIRECTOR

Central Study Contacts

savitha subramaniam, PhD

CONTACT

7082910471; savitharaj@gmail.com

Tanvi Bhatt, PhD

CONTACT

3129270311; tbhatt6@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Intervention provider and assessor were all blinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 11, 2019
• Study Start: September 9, 2019
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)