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Clinical Trials/NCT04647812
NCT04647812
Unknown
Not Applicable

Technology-assisted Rehabilitation After Acute Stroke

Vetrea Terveys Oy1 site in 1 country40 target enrollmentJanuary 4, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Vetrea Terveys Oy
Enrollment
40
Locations
1
Primary Endpoint
WHODAS 2.0
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
September 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kauko Pitkänen

Chief physician

Vetrea Terveys Oy

Eligibility Criteria

Inclusion Criteria

  • age 18 or more
  • first stroke

Exclusion Criteria

  • unstable cardiopulmonary condition
  • severe cognitive disorder

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)

Study Sites (1)

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