Technology-assisted Rehabilitation After Acute Stroke

NCT ID: NCT04647812

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-09-30

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.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Consecutive cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Technology-assisted rehabilitation

Augmented exercise therapy with novel technology

Group Type EXPERIMENTAL

Technology-assisted rehabilitation

Intervention Type BEHAVIORAL

Augmented exercise therapy with novel technology and home-based telerehabilitation

Conventional rehabilitation

Traditional multidisciplinary rehabilitation

Group Type EXPERIMENTAL

Conventional rehabilitation

Intervention Type BEHAVIORAL

Traditional multidisciplinary in-patient rehabilitation

Interventions

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Technology-assisted rehabilitation

Augmented exercise therapy with novel technology and home-based telerehabilitation

Intervention Type BEHAVIORAL

Conventional rehabilitation

Traditional multidisciplinary in-patient rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 18 or more
* first stroke

Exclusion Criteria

* unstable cardiopulmonary condition
* severe cognitive disorder
* aphasia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

City of Kuopio

OTHER_GOV

Sponsor Role collaborator

Vetrea Terveys Oy

OTHER

Sponsor Role lead

Responsible Party

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Kauko Pitkänen

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kauko Pitkänen, MD, PhD

Role: STUDY_DIRECTOR

Vetrea Terveys Oy

Locations

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Vetrea

Kuopio, Northern Savonia, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Kauko Pitkänen, MD, PhD

Role: CONTACT

0505965289 ext. 358

Laura Airaksinen

Role: CONTACT

0407291908 ext. 358

Facility Contacts

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Kauko Pitkänen, PhD

Role: primary

+358505965289

Other Identifiers

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Taku2020

Identifier Type: -

Identifier Source: org_study_id

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