Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430504
• Other study ID #: EMoK
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: February 2022

Study information

• Verified date: November 2020
• Source: Vetrea Terveys Oy
• Contact: Kauko Pitkänen, MD, PhD
• Phone: 0505965289
• Email: kauko.pitkanen[@]vetrea.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• multidisciplinary telerehabilitation
weekly video meetings to instruct and monitor self-exercises at home

Locations

Country	Name	City	State
Finland	VetreaNeuron	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	Goal Attainment Scaling	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	Beck Depression Inventory	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
Secondary	WHOQOL-Bref	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