Technology-assisted Rehabilitation After Acute Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Behavioral: Technology-assisted rehabilitation; Behavioral: Conventional rehabilitation

• Registration Number: NCT04647812
• Lead Sponsor: Vetrea Terveys Oy

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 Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-01
• Study Start: 2021-01-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age 18 or more
• first stroke

Exclusion Criteria

• unstable cardiopulmonary condition
• severe cognitive disorder
• aphasia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Technology-assisted rehabilitation	Technology-assisted rehabilitation	Augmented exercise therapy with novel technology
Conventional rehabilitation	Conventional rehabilitation	Traditional multidisciplinary rehabilitation

Primary Outcome Measures

Name	Time	Method
WHODAS 2.0	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	6 months	amount and costs of social and health care services used

Secondary Outcome Measures

Name	Time	Method
Hand grip force	6 months	hand grip
Shoulder elevation test	6 months	shoulder range of motion
FAC	6 months	Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).
PROMIS Global 10	6 months	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.

Trial Locations

Locations (1)

Vetrea; 🇫🇮 Kuopio, North Savo, Finland