Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

Concussion Clinical Trial

Official title:

Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03103529
• Other study ID #: 13-142-PED
• Status: Active, not recruiting
• Phase: N/A
• First received: April 1, 2017
• Last updated: May 1, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2017
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussion
• Post-Concussion Symptoms
• Post-Concussion Syndrome

Intervention

Other:
• Active Rehabilitation

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital, MUHC	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-concussion symptoms	Post-Concussion Symptoms Inventory scale total score	6 weeks post-injury