NCT06060470Not yet recruiting
Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Mechanism of Action That Underlies an Active Balance and Cardio Care Intervention on Physical and Cardiovascular Health in People With Chronic Stroke
Source: ClinicalTrials.gov · Last updated 18 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 community and other facilities offering rehabilitation in the form of conventional, recreational and alternative therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke 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 therapies such as exergaming-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 data on compliance and efficacy of a randomized controlled trial. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Sept 2023
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Stroke
- NCT number
- NCT06060470
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Oct 2024 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- active or untreated infection,
- thromboembolic disease,
- 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.
- Uncontrolled hypertension (systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting).
Lab values
- Severe cardiac disease (New York Heart Association classification of IIIV) \[1\]. Exclusion Criteria for Laboratory Slip test.
Age
- Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) \[3\].
Other
- aphasia \<71% on Mississippi Aphasia Screening Test
- \>15 on Geriatric Depression Scale.
- unhealed pressure sores,
- severe contractures,
- active heterotrophic ossification in the lower extremities,
- lower limb fractures,
- 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
- Oxygen saturation (measured by pulse oximeter) during resting \< 95%.
- T score of \< -2 on the Bone density, measured through via the heel ultrasound machine.
Who the study is looking for
- 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).
Age in the registry: 45 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.