NCT04430504

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

May 29, 2020

Last Update Submit

November 16, 2020

Conditions

Traumatic Brain Injury

Keywords

TelerehabilitationCase seriesTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Beck Depression Inventory

    20 weeks

  • WHOQOL-Bref

    20 weeks

Study Arms (1)

Telerehabilitation (TR)

EXPERIMENTAL

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

Behavioral: multidisciplinary telerehabilitation

Interventions

multidisciplinary telerehabilitationBEHAVIORAL

weekly video meetings to instruct and monitor self-exercises at home

Telerehabilitation (TR)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sequelae of traumatic brain injury
  • capable of doing self exercises at home and participating in video meetings

You may not qualify if:

  • moderate or severe aphasia
  • poor recovery potential for return to school or working life based on clinical assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VetreaNeuron

Kuopio, Northern Savonia, 70820, Finland

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Kauko Pitkänen, MD, PhD

    VetreaNeuron

    STUDY DIRECTOR

Central Study Contacts

Kauko Pitkänen, MD, PhD

CONTACT

0505965289kauko.pitkanen@vetrea.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series of eligible patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 12, 2020

Study Start

November 16, 2020

Primary Completion

November 1, 2021

Study Completion

February 1, 2022

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)