Safety and Feasibility of Early Active Rehabilitation in... | NCT03103529

Studies
Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

NCT03103529

Sponsor

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

Status

Unknown status

Last Update Posted

May 4, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Post-Concussion Symptoms
Concussion

Interventions

Active Rehabilitation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jul 2017Estimated

First Submitted Date

Apr 1, 2017

First Submission Date that Met QC Criteria

Apr 1, 2017

First Posted Date

Apr 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2017

Last Update Posted Date

May 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Isabelle Gagnon, Clinician Scientist/Associate Professor, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Active Rehabilitation	Other		Early Rehab late rehab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-concussion symptoms	Post-Concussion Symptoms Inventory scale total score	6 weeks post-injury

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montreal Children's Hospital, MUHC		Montreal	Quebec	H4A3J1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D038223	Post-Concussion Syndrome
D001924	Brain Concussion

Ancestor Terms

ID	Term
D016489	Head Injuries, Closed
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided