Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A Randomised Control Trial

Not Applicable

• Conditions: Concussion / Mild Traumatic Brain Injury; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12622001549718
• Lead Sponsor: Queensland Children's Hospital - Queensland Paediatric Rehabilitation Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-15
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Any child age 8 to 18 years of age
-Mild traumatic brain injury/concussion (as above)
-Any increase in symptoms compared to pre-injury symptoms score
-Access to device and internet to complete telehealth sessions (Telehealth in the Home checklist)
-Overall symptoms of less than 6/10 at rest
-Ability to walk independently (eg. Dizziness/imbalance not a risk factor for falls)
-Access to space for exercise

Exclusion Criteria

-a significant medical history that would contraindicate a home exercise program
-a previous concussion within the last 3 months,
-persistent symptoms following a previous concussion
-inability to complete questionnaires
-parents unable to provide informed consent (diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable), or
-inability to provide intervention due to a lack of computer, internet service, or mobile phone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post Concussion Symptom Inventory (PSCI) change[PSCI - Initial Contact with Nursing Staff (Both sides of RCT)<br>PSCI - Week 1 (Initial Tele-exercise appointment (Intervention Group)<br>PSCI - Week 5 Either RedCap or Nursing Phone Call (Both sides of RCT)]

Secondary Outcome Measures

Name	Time	Method
Pediatric Quality of Life Inventory (PedsQL)[Initial Nursing phone call (both sides of RCT)<br>Week 1 - Initial Tele-exercise session (intervention Group only)<br>Week 5 - Either RedCap or Nursing Phone Call<br>];Child Health Utility instrument (CHU9D) - used to measure of health-related quality of life. It consists of a short questionnaire and a set of preference weights using general population values. The questionnaire has 9 questions with 5 response levels per question and is self-completed by the child. [Initial Nursing phone call (both sides of RCT)<br>Week 1 - Initial Tele-exercise session (intervention Group only)<br>Week 5 - Either RedCap or Nursing Phone Call]