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Technology-assisted Rehabilitation After Acute Stroke

Technology-assisted Rehabilitation After Acute Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04647812
Enrollment
40
Registered
2020-12-01
Start date
2021-01-04
Completion date
2022-09-30
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

Augmented exercise therapy with novel technology and home-based telerehabilitation

BEHAVIORALConventional rehabilitation

Traditional multidisciplinary in-patient rehabilitation

Sponsors

Kuopio University Hospital
CollaboratorOTHER
City of Kuopio
CollaboratorOTHER_GOV
Vetrea Terveys Oy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Consecutive cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age 18 or more * first stroke

Exclusion criteria

* unstable cardiopulmonary condition * severe cognitive disorder * aphasia

Design outcomes

Primary

MeasureTime frameDescription
WHODAS 2.06 monthsWorld 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 costs6 monthsamount and costs of social and health care services used

Secondary

MeasureTime frameDescription
PROMIS Global 106 monthsPatient 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.
FAC6 monthsFunctional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).
Hand grip force6 monthshand grip
Shoulder elevation test6 monthsshoulder range of motion

Countries

Finland

Contacts

Primary ContactKauko Pitkänen, MD, PhD
kauko.pitkanen@vetrea.fi0505965289
Backup ContactLaura Airaksinen
laura.airaksinen@vetrea.fi0407291908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026