Clinical trial NCT03869138: Alternative Therapies for Improving Physical Function in Individuals With Stroke
Official title: Alternative Therapies for Improving Physical Function in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change in Postural Stability
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
measure: Compliance to therapy (total time spent over the intervention duration)
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
measure: Change in reaction time with functional arm reach
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
Secondary outcomes:
measure: Change in Movement Velocity
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
measure: Change in physical activity
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
measure: Change in Berg Balance Scale
timeFrame: Baseline (week 0), Mid-training (2nd week), and Post-training (7th week)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Tanvi Bhatt
role: STUDY_DIRECTOR
References: