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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04116190
Other study ID # Aimo2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date May 31, 2018

Study information

Verified date October 2019
Source Vetrea Terveys Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 31, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telerehabilitation
Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.
Conventional inpatient rehabilitation
Multidisciplinary inpatient rehabilitation, no adjustments due to the study.

Locations

Country Name City State
Finland Vetrea Kuopio North Savo

Sponsors (1)

Lead Sponsor Collaborator
Vetrea Terveys Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks
Secondary 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. 8 weeks
Secondary Beck Depression Inventory (BDI 21) The Beck Depression Inventory for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome. 8 weeks
Secondary Barthel Index for assessing need for help in basic activities of daily living. Scale range is 0-100 and higher scores indicate better outcome. 8 weeks
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