Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

NCT ID: NCT03103529

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Concussion Symptoms Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Rehab

Children will begin active rehabilitation 2 weeks post-injury

Group Type EXPERIMENTAL

Active Rehabilitation

Intervention Type OTHER

late rehab

Children will begin active rehabilitation 4 weeks post-injury

Group Type ACTIVE_COMPARATOR

Active Rehabilitation

Intervention Type OTHER

Interventions

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Active Rehabilitation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* co-morbidity preventing children from participating in intervention
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Gagnon

Clinician Scientist/Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montreal Children's Hospital, MUHC

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-142-PED

Identifier Type: -

Identifier Source: org_study_id

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