Using virtual reality dance therapy to improve physical function in stroke patients

Alternative Therapies for Improving Physical Function in Individuals With Stroke

This study is testing if virtual reality dance therapy can help stroke patients improve their physical and mental abilities better than traditional rehab methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT03869138 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility and efficacy of a virtual reality-based dance and gaming therapy for individuals with neurological impairments, particularly stroke. The study will compare this alternative therapy to conventional rehabilitation methods to assess improvements in physical and cognitive functions. Participants will engage in high-intensity and long-duration interventions, with outcomes measured in terms of safety, compliance, and various functional domains. The findings will help inform the development of a larger randomized controlled trial for future funding.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 90 with a history of neurological impairment, such as stroke, Parkinson's disease, or multiple sclerosis, who can follow instructions and participate actively.

Not a fit: Patients with severe cognitive impairment or those unable to stand and walk, as well as those with advanced stages of neurological diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel and engaging rehabilitation option that enhances recovery for stroke patients.

How similar studies have performed: While traditional rehabilitation methods have been well-studied, the use of virtual reality dance therapy is a novel approach that has not been extensively tested in this context.

Eligibility criteria

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) \[1\].

  13\. Exclusion Criteria for Laboratory Slip test. i. T score of \< -2 on the Bone density, measured through via the heel ultrasound machine. It must be noted that the particpants will be explained that they were excluded from the balance test to avoid any injury risk as there is a chance that their bones may be weak. However, they will be told that the ultrasound test does give more false positives (i.e. lower scores indicating weak bones when in fact they are not weak) and that they probably could see their physician for a more conclusive test (such as the full-body bone scan).

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.

Please note that the exclusion criteria for the Laboratory Slip test will only exclude participants from taking this test. They will still be part of the study if other inclusion /exclusion criteria are met and will go through the other tests and the intervention protocol.

Where this trial is running

Chicago, Illinois and 1 other locations

• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
• University of Illinois Chicago — Chicago, Illinois, United States (Suspended)

Study contacts

• Study coordinator: savitha subramaniam, PhD

Conditions Stroke