Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

November 16, 2020 updated by: Vetrea Terveys Oy
The purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to participate in a multidisciplinary telerehabilitation containing total of 20 video meetings over a period of 4-5 months. The study design consists of a 3-day visit in rehabilitation ward for the pre-treatment clinical assessments and education on the telerehabilitation protocol. A self-exercise program is supervised and monitored using a health platform application on a tablet computer through weekly video meetings. A digital diary recordings enable the therapists to track on the progress of therapies. The primary goal is to achieve the individual goals set in the Goal Attainment Scaling. The secondary goals are related to the improvement of psychological well-being (BDI) and quality of life (WHOQOL-Bref).

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • North Savo
      • Kuopio, North Savo, Finland, 70820
        • Recruiting
        • VetreaNeuron
        • Contact:
        • Principal Investigator:
          • Leena Korhonen, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sequelae of traumatic brain injury
  • capable of doing self exercises at home and participating in video meetings

Exclusion Criteria:

  • moderate or severe aphasia
  • poor recovery potential for return to school or working life based on clinical assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation (TR)
Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments
Behavioral: multidisciplinary telerehabilitation
weekly video meetings to instruct and monitor self-exercises at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scaling
Time Frame: 20 weeks
Outcome scaling: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), +2 (best expected outcome)
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: 20 weeks
21-question inventory to yield a total score 0-63: 0-13 (no depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)
20 weeks
WHOQOL-Bref
Time Frame: 20 weeks
26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each domain scoring 0-100 (0 = worst, 100= best possible) to compare with age-related mean values.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vetrea Terveys Oy

Investigators

  • Study Director: Kauko Pitkänen, MD, PhD, VetreaNeuron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMoK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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