Technology-assisted Rehabilitation After Acute Stroke

Sponsor
Vetrea Terveys Oy (Other)
Overall Status
Recruiting
CT.gov ID
NCT04647812
Collaborator
Kuopio University Hospital (Other), City of Kuopio (Other)
40
1
2
19.9
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Technology-assisted rehabilitation
  • Behavioral: Conventional rehabilitation
N/A

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
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Consecutive cohort studyConsecutive cohort study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Technology-assisted Rehabilitation After Acute Stroke
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Technology-assisted rehabilitation

Augmented exercise therapy with novel technology

Behavioral: Technology-assisted rehabilitation
Augmented exercise therapy with novel technology and home-based telerehabilitation

Experimental: Conventional rehabilitation

Traditional multidisciplinary rehabilitation

Behavioral: Conventional rehabilitation
Traditional multidisciplinary in-patient rehabilitation

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. service use and costs [6 months]

    amount and costs of social and health care services used

Secondary Outcome Measures

  1. 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.

  2. FAC [6 months]

    Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).

  3. Hand grip force [6 months]

    hand grip

  4. Shoulder elevation test [6 months]

    shoulder range of motion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age 18 or more

  • first stroke

Exclusion Criteria:
  • unstable cardiopulmonary condition

  • severe cognitive disorder

  • aphasia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vetrea Kuopio North Savo Finland 71130

Sponsors and Collaborators

  • Vetrea Terveys Oy
  • Kuopio University Hospital
  • City of Kuopio

Investigators

  • Study Director: Kauko Pitkänen, MD, PhD, Vetrea Terveys Oy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kauko Pitkänen, Chief physician, Vetrea Terveys Oy
ClinicalTrials.gov Identifier:
NCT04647812
Other Study ID Numbers:
  • Taku2020
First Posted:
Dec 1, 2020
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2021