Technology-assisted Rehabilitation After Acute Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Technology-assisted rehabilitation; Behavioral: Conventional rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kauko Pitkänen, MD, PhD; Phone Number: 358 0505965289; Email: kauko.pitkanen@vetrea.fi
• Study Contact Backup: Name: Laura Airaksinen; Phone Number: 358 0407291908; Email: laura.airaksinen@vetrea.fi

Study Locations

• Finland
  • North Savo
    • Kuopio, North Savo, Finland, 71130
      • Recruiting
      • Vetrea
      • Contact: Kauko Pitkänen, PhD; Phone Number: +358505965289; Email: kauko.pitkanen@vetrea.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 18 or more
• first stroke

Exclusion Criteria:

• unstable cardiopulmonary condition
• severe cognitive disorder
• aphasia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vetrea Terveys Oy
• Collaborators: Kuopio University Hospital; City of Kuopio
• Investigators: Study Director: Kauko Pitkänen, MD, PhD, Vetrea Terveys Oy

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Taku2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No