Status:
RECRUITING
Alternative Therapies for Improving Physical Function in Individuals With Stroke
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
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 amelio...
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 tri...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03869138
Start Date
September 9 2019
End Date
September 30 2025
Last Update
September 15 2025
Active Locations (2)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612