NCT04116190

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

October 3, 2019

Conditions

Stroke Sequelae

Keywords

rehabilitationstroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • World Health Organization Quality of Life - short version (WHOQOL-Bref)

    8 weeks

  • Beck Depression Inventory (BDI 21)

    8 weeks

  • Barthel Index

    8 weeks

Study Arms (2)

Telerehabilitation (TR)

EXPERIMENTAL

Shortened inpatient rehabilitation mixed with home-based telerehabilitation.

Behavioral: Telerehabilitation

Conventional rehabilitation (CR)

EXPERIMENTAL

Traditional inpatient rehabilitation

Behavioral: Conventional inpatient rehabilitation

Interventions

TelerehabilitationBEHAVIORAL

Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.

Telerehabilitation (TR)
Conventional inpatient rehabilitationBEHAVIORAL

Multidisciplinary inpatient rehabilitation, no adjustments due to the study.

Conventional rehabilitation (CR)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • no access or capability to use a personal computer
  • significant problems in hearing, seeing or understanding information related to the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vetrea

Kuopio, Northern Savonia, 71130, Finland

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Kauko Pitkanen, PhD

    VetreaNeuron

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Consecutive sampling
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

October 4, 2019

Study Start

September 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 31, 2018

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations

FI(1)