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Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
multidisciplinary telerehabilitation
Sponsored by
Vetrea Terveys Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Telerehabilitation, Case series, Traumatic brain injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • VetreaNeuronRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telerehabilitation (TR)

Arm Description

Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.

Full Information

First Posted
May 29, 2020
Last Updated
November 16, 2020
Sponsor
Vetrea Terveys Oy
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1. Study Identification

Unique Protocol Identification Number
NCT04430504
Brief Title
Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
Official Title
Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vetrea Terveys Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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..
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Telerehabilitation, Case series, Traumatic brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case series of eligible patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation (TR)
Arm Type
Experimental
Arm Description
Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary telerehabilitation
Intervention Description
weekly video meetings to instruct and monitor self-exercises at home
Primary Outcome Measure Information:
Title
Goal Attainment Scaling
Description
Outcome scaling: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), +2 (best expected outcome)
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
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)
Time Frame
20 weeks
Title
WHOQOL-Bref
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kauko Pitkänen, MD, PhD
Phone
0505965289
Ext
358
Email
kauko.pitkanen@vetrea.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kauko Pitkänen, MD, PhD
Organizational Affiliation
VetreaNeuron
Official's Role
Study Director
Facility Information:
Facility Name
VetreaNeuron
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
70820
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kauko Pitkänen
Phone
0505965289
Email
kauko.pitkanen@vetrea.fi
First Name & Middle Initial & Last Name & Degree
Leena Korhonen, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury

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