Technology-assisted Rehabilitation After Acute Stroke
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vetrea Terveys Oy
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- WHODAS 2.0
Study Overview
Brief Summary
The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.
Detailed Description
The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 18 or more
- •first stroke
Exclusion Criteria
- •unstable cardiopulmonary condition
- •severe cognitive disorder
Arms & Interventions
Technology-assisted rehabilitation
Augmented exercise therapy with novel technology
Intervention: Technology-assisted rehabilitation (Behavioral)
Conventional rehabilitation
Traditional multidisciplinary rehabilitation
Intervention: Conventional rehabilitation (Behavioral)
Outcomes
Primary Outcomes
WHODAS 2.0
Time Frame: 6 months
World Health Organization Disability Assessment Schedule - 12 questions scoring 1 to 5 yielding a total score from 12 to 60. A higher score means an increasing disability.
service use and costs
Time Frame: 6 months
amount and costs of social and health care services used
Secondary Outcomes
- Shoulder elevation test(6 months)
- FAC(6 months)
- PROMIS Global 10(6 months)
- Hand grip force(6 months)
Investigators
Kauko Pitkänen
Chief physician
Vetrea Terveys Oy