Traumatic Brain InjuryNCT04430504
Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
A study testing multidisciplinary telerehabilitation in people with Traumatic Brain Injury, run by Vetrea Terveys Oy at 1 site in Finland.
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.. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- multidisciplinary telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 16 Nov 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sequelae of traumatic brain injury
- capable of doing self exercises at home and participating in video meetings
Who cannot join
- moderate or severe aphasia
- poor recovery potential for return to school or working life based on clinical assessment
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
VetreaNeuron
Kuopio, Northern Savonia, 70820
Kauko Pitkänen, 0505965289, kauko.pitkanen@vetrea.fi
Leena Korhonen, MSc
About this study
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..
Read the 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- multidisciplinary telerehabilitation
- Keywords
- Telerehabilitation, Case series, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary telerehabilitationBehavioural
weekly video meetings to instruct and monitor self-exercises at home
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation (TR) | Experimental | Multidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments Receives: Behavioral: multidisciplinary telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 20 weeks
Secondary outcomes (2)
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)
Measured: 20 weeks
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start16 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series of eligible patients
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vetrea Terveys Oy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kauko Pitkänen, MD, PhD, Study director, VetreaNeuron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430504
- Sponsor's protocol ID
- EMoK
- Status last verified
- Nov 2020
- First submitted
- 29 May 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Attainment Evaluation of Multidisciplinary Telerehabilitation After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04430504
- Acronym / sponsor ID
- EMoK
- Conditions
- Traumatic Brain Injury
- Keywords
- Telerehabilitation, Case series, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vetrea Terveys OyUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series of eligible patients
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation (TR) | Experimental | Behavioral: multidisciplinary telerehabilitationMultidisciplinary, weekly video meetings, self-exercises at home, digital diary recordings, follow-up assessments |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sequelae of traumatic brain injury
- capable of doing self exercises at home and participating in video meetings
Key exclusion criteria (2 listed)
- moderate or severe aphasia
- poor recovery potential for return to school or working life based on clinical assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary telerehabilitationweekly video meetings to instruct and monitor self-exercises at home | Behavioural | Telerehabilitation (TR) |
Primary outcome
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)
2 secondary outcomes
Beck Depression Inventory
Time frame: 20 weeks
WHOQOL-Bref
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kauko Pitkänen, MD, PhD study director
VetreaNeuron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary telerehabilitation in people with Traumatic Brain Injury, run by Vetrea Terveys Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kauko Pitkänen, MD, PhD (0505965289 ext. 358, kauko.pitkanen@vetrea.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.