Status:
NOT_YET_RECRUITING
Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Chronic Stroke
Eligibility:
All Genders
45-90 years
Phase:
NA
Brief Summary
Neurological impairment such as stroke is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing commu...
Detailed Description
While conventional balance training facilitates balance control and gait functions, the exercises involved in the training are labor-intensive, highly repetitious leading to monotonicity and decreased...
Eligibility Criteria
Inclusion
- 45 to 90 years of age.
- Able to follow instructions provided in English.
- History of neurological impairment (Stroke) 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).
- 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).
Exclusion
- Cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment and a score of \<25 on Mini Mental State Exam Score;
- aphasia \<71% on Mississippi Aphasia Screening Test
- \>15 on Geriatric Depression Scale.
- 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,
- Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
- Pregnancy.
- Uncontrolled pain \>3/10 on VAS.
- Complains of shortness of breath
- Uncontrolled hypertension (systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting).
- 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%.
- Severe cardiac disease (New York Heart Association classification of IIIV) \[1\]. Exclusion Criteria for Laboratory Slip test.
- T score of \< -2 on the Bone density, measured through via the heel ultrasound machine.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06060470
Start Date
October 1 2024
End Date
October 1 2028
Last Update
October 18 2023
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612