Back to resultsA Multidisciplinary Telerehabilitation for Stroke Patients
Primary Purpose
Stroke Sequelae
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Telerehabilitation
Conventional inpatient rehabilitation
Sponsored by
About this trial
This is an interventional other trial for Stroke Sequelae focused on measuring rehabilitation, stroke
Eligibility Criteria
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
Sites / Locations
- Vetrea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Telerehabilitation (TR)
Conventional rehabilitation (CR)
Arm Description
Shortened inpatient rehabilitation mixed with home-based telerehabilitation.
Traditional inpatient rehabilitation
Outcomes
Primary Outcome Measures
Finnish version of the Functional Status Questionnaire (FSQfin)
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.
Secondary Outcome Measures
World Health Organization Quality of Life - short version (WHOQOL-Bref)
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.
Beck Depression Inventory (BDI 21)
The Beck Depression Inventory for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.
Barthel Index
for assessing need for help in basic activities of daily living. Scale range is 0-100 and higher scores indicate better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04116190
Brief Title
A Multidisciplinary Telerehabilitation for Stroke Patients
Official Title
Feasibility of Multidisciplinary Telerehabilitation in Patients With Stroke - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vetrea Terveys Oy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae
Keywords
rehabilitation, stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Consecutive sampling
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation (TR)
Arm Type
Experimental
Arm Description
Shortened inpatient rehabilitation mixed with home-based telerehabilitation.
Arm Title
Conventional rehabilitation (CR)
Arm Type
Experimental
Arm Description
Traditional inpatient rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation
Intervention Description
Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.
Intervention Type
Behavioral
Intervention Name(s)
Conventional inpatient rehabilitation
Intervention Description
Multidisciplinary inpatient rehabilitation, no adjustments due to the study.
Primary Outcome Measure Information:
Title
Finnish version of the Functional Status Questionnaire (FSQfin)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life - short version (WHOQOL-Bref)
Description
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.
Time Frame
8 weeks
Title
Beck Depression Inventory (BDI 21)
Description
The Beck Depression Inventory for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome.
Time Frame
8 weeks
Title
Barthel Index
Description
for assessing need for help in basic activities of daily living. Scale range is 0-100 and higher scores indicate better outcome.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kauko Pitkanen, PhD
Organizational Affiliation
VetreaNeuron
Official's Role
Study Director
Facility Information:
Facility Name
Vetrea
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
71130
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
A Multidisciplinary Telerehabilitation for Stroke Patients
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