NCT03103529

Brief Summary

It has been suggested that activity immediately following concussion is detrimental to recovery and may lead to long term impairments. The animal model has shown that exercise too soon can lead to neurometabolic energy imbalances within the brain. However, there is also evidence to suggest that prolonged inactivity has negative consequences that may contribute to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active rehabilitation protocol for patients who are slow to recovery is an important factor in concussion management.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

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

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

April 1, 2017

Last Update Submit

May 1, 2017

Conditions

Post-Concussion SymptomsConcussion

Outcome Measures

Primary Outcomes (1)

  • Post-concussion symptoms

    Post-Concussion Symptoms Inventory scale total score

    6 weeks post-injury

Study Arms (2)

Early Rehab

EXPERIMENTAL

Children will begin active rehabilitation 2 weeks post-injury

Other: Active Rehabilitation

late rehab

ACTIVE COMPARATOR

Children will begin active rehabilitation 4 weeks post-injury

Other: Active Rehabilitation

Interventions

Active RehabilitationOTHER
Early Rehablate rehab

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • referred to the mTBI clinic of the MCH for atypical recovery (defined as the presence of symptoms with little improvement at 10 days post-injury preventing them from entering standard return to activities protocols)

You may not qualify if:

  • co-morbidity preventing children from participating in intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Children's Hospital, MUHC

Montreal, Quebec, H4A3J1, Canada

Location

MeSH Terms

Conditions

Post-Concussion SyndromeBrain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist/Associate Professor

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 6, 2017

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

July 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

CA(1)