- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04116190
A Multidisciplinary Telerehabilitation for Stroke Patients
Feasibility of Multidisciplinary Telerehabilitation in Patients With Stroke - a Pilot Study
Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients.
Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only.
Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting.
Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Savo
-
Kuopio, North Savo, Finland, 71130
- Vetrea
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- chronic stroke (6 months or more) patient living in home
- eligible to receive rehabilitation funded by the Social Insurance Institution (meets the criteria of chronic disability and need for rehabilitation)
- for intervention group: capable to use a personal computer and telecommunication
Exclusion Criteria:
- no access or capability to use a personal computer
- significant problems in hearing, seeing or understanding information related to the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Telerehabilitation (TR)
Shortened inpatient rehabilitation mixed with home-based telerehabilitation.
|
Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.
|
EXPERIMENTAL: Conventional rehabilitation (CR)
Traditional inpatient rehabilitation
|
Multidisciplinary inpatient rehabilitation, no adjustments due to the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finnish version of the Functional Status Questionnaire (FSQfin)
Time Frame: 8 weeks
|
Functional Status Questionnaire for evaluating self-management in home.
Includes three dimensions: self-care, mobility and domestic life.
Scale range for each dimension is 0-100 and higher scores indicate better outcome.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
World Health Organization Quality of Life - short version (WHOQOL-Bref)
Time Frame: 8 weeks
|
Quality of life assessment.
Includes four dimensions: physical health, psychological health, social relationships and environment.
Scale range for each dimension is 0-100 and higher scores indicate better outcome.
|
8 weeks
|
Beck Depression Inventory (BDI 21)
Time Frame: 8 weeks
|
The Beck Depression Inventory for mood assessment.
Scale range is 0-63 and higher scores indicate worse outcome.
|
8 weeks
|
Barthel Index
Time Frame: 8 weeks
|
for assessing need for help in basic activities of daily living.
Scale range is 0-100 and higher scores indicate better outcome.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kauko Pitkanen, PhD, VetreaNeuron
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aimo2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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