Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Sponsor

Vetrea Terveys Oy (Other)

Overall Status

Recruiting

CT.gov ID

NCT04430504

Collaborator

(none)

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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..

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Behavioral: multidisciplinary telerehabilitation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Case series of eligible patientsCase series of eligible patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Goal Attainment Scaling [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)

Secondary Outcome Measures

Beck Depression Inventory [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)
WHOQOL-Bref [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VetreaNeuron	Kuopio	North Savo	Finland	70820

Sponsors and Collaborators

Vetrea Terveys Oy

Investigators

Study Director: Kauko Pitkänen, MD, PhD, VetreaNeuron

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vetrea Terveys Oy

ClinicalTrials.gov Identifier:

NCT04430504

Other Study ID Numbers:

EMoK

First Posted:

Jun 12, 2020

Last Update Posted:

Nov 17, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vetrea Terveys Oy

Telerehabilitation

Case series

Traumatic brain injury

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Nov 17, 2020