- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430504
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 Contact
- Name: Kauko Pitkänen, MD, PhD
- Phone Number: 358 0505965289
- Email: kauko.pitkanen@vetrea.fi
Study Locations
-
-
North Savo
-
Kuopio, North Savo, Finland, 70820
- Recruiting
- VetreaNeuron
-
Contact:
- Kauko Pitkänen
- Phone Number: 0505965289
- Email: kauko.pitkanen@vetrea.fi
-
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
|
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
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
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.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States
Clinical Trials on multidisciplinary telerehabilitation
-
Oslo University HospitalOslo University CollegeCompletedDizziness | Traumatic Brain Injury | Brain Concussion | Head InjuryNorway
-
Marmara UniversityEnrolling by invitationHemiparetic Cerebral PalsyTurkey
-
Saglik Bilimleri UniversitesiCompletedQuality of Life | Fatigue | Muscle Weakness | Pulmonary Disease | COPD | Respiratory Disease | Dyspnea | Muscle Strength | Functional Capacity | Severe Chronic Obstructive Pulmonary Disease | Motor Imagery | Muscle; AccessoryTurkey
-
Bright Cloud International CorpNational Cancer Institute (NCI); Rutgers, The State University of New JerseyRecruitingCognitive Impairment, MildUnited States
-
University of Eastern FinlandOulu University Hospital; Kuopio University HospitalNot yet recruitingCoronary Artery Disease
-
Instituto Mexicano del Seguro SocialRecruitingNeck Pain | Neck SprainMexico
-
University of MinnesotaRecruitingTemporomandibular Disorder | TMJ Disc Displacement With Reduction | TMJ Disc Displacement Without Reduction | Masticatory Myofascial Pain | TMJ Arthralgia | TMD HeadacheUnited States
-
VA Office of Research and DevelopmentNot yet recruiting
-
University Hospital, GrenobleNot yet recruitingChronic Thromboembolic Pulmonary Hypertension
-
Aalborg UniversityViborg Regional Hospital; Aage and Johanne Louis-Hansens Foundation; Laboratory... and other collaboratorsRecruiting