Technology-assisted Rehabilitation After Acute Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technology-assisted Rehabilitation After Acute Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Technology-assisted rehabilitation
* Behavioral: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or more first stroke Exclusion Criteria: unstable cardiopulmonary condition severe cognitive disorder aphasia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Consecutive cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology-assisted rehabilitation<br>Augmented exercise therapy with novel technology | Behavioral: Technology-assisted rehabilitation<br>* Augmented exercise therapy with novel technology and home-based telerehabilitation<br>|
| Experimental: Conventional rehabilitation<br>Traditional multidisciplinary rehabilitation | Behavioral: Conventional rehabilitation<br>* Traditional multidisciplinary in-patient rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHODAS 2.0 | 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. | 6 months | 
| service use and costs | amount and costs of social and health care services used | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Global 10 | Patient Reported Outcome Measurement Information System - a generic global health scale v1.2 consists of 10 questions across 6 health items. Two of the items (Physical and Mental) can be converted to T-scores allowing comparisons to a general population. | 6 months | 
| FAC | Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces). | 6 months | 
| Hand grip force | hand grip | 6 months | 
| Shoulder elevation test | shoulder range of motion | 6 months |