NCT04647812

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

November 30, 2020

Last Update Submit

April 14, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • PROMIS Global 10

    6 months

  • FAC

    6 months

  • Hand grip force

    6 months

  • Shoulder elevation test

    6 months

Study Arms (2)

Technology-assisted rehabilitation

EXPERIMENTAL

Augmented exercise therapy with novel technology

Behavioral: Technology-assisted rehabilitation

Conventional rehabilitation

EXPERIMENTAL

Traditional multidisciplinary rehabilitation

Behavioral: Conventional rehabilitation

Interventions

Augmented exercise therapy with novel technology and home-based telerehabilitation

Technology-assisted rehabilitation

Traditional multidisciplinary in-patient rehabilitation

Conventional rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or more
  • first stroke

You may not qualify if:

  • unstable cardiopulmonary condition
  • severe cognitive disorder
  • aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vetrea

Kuopio, Northern Savonia, 71130, Finland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kauko Pitkänen, MD, PhD

    Vetrea Terveys Oy

    STUDY DIRECTOR

Central Study Contacts

Kauko Pitkänen, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Consecutive cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 1, 2020

Study Start

January 4, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations