Technology-assisted Rehabilitation After Acute Stroke

Stroke Clinical Trial

Official title:

Technology-assisted Rehabilitation After Acute Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04647812
• Other study ID #: Taku2020
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: Vetrea Terveys Oy
• Contact: Kauko Pitkänen, MD, PhD
• Phone: 0505965289
• Email: kauko.pitkanen[@]vetrea.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 or more

• first stroke

Exclusion Criteria:

• unstable cardiopulmonary condition

• severe cognitive disorder

• aphasia

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Technology-assisted rehabilitation
Augmented exercise therapy with novel technology and home-based telerehabilitation
• Conventional rehabilitation
Traditional multidisciplinary in-patient rehabilitation

Locations

Country	Name	City	State
Finland	Vetrea	Kuopio	North Savo

Sponsors (3)

Lead Sponsor	Collaborator
Vetrea Terveys Oy	City of Kuopio, Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	service use and costs	amount and costs of social and health care services used	6 months
Secondary	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
Secondary	FAC	Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).	6 months
Secondary	Hand grip force	hand grip	6 months
Secondary	Shoulder elevation test	shoulder range of motion	6 months