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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: A randomized controlled trial of a 4‐week tele‐exercise program compared to standard care to improve recovery from concussion in children and youth. The study will be conducted as a randomized controlled study to determine if the additional of supervised and graded return to aerobic exercise has an impact on the reduction in symptoms of children/adolescents following a concussion. The RCT design was chosen as it is considered to provide the most reliable evidence on the effectiveness of the interventions because the processes we will use during the conduct of the RCT minimizes the risk of other factors influencing the results. Our study will assess a home‐based individualized graded exercise program tailored for the child and family circumstances (using telehealth) for 4 weeks. This will involve weekly tele‐exercise check‐in sessions with a study physiotherapist. Here, aerobic exercise activity will gradually increase until pre‐injury exercise is achieved. Exercise will be gradually increased based on the child/youth’s perceived exertion (as informed by the 10m Modified Shuttle Test (MST) ‐ ACTR12622001051730). The OMNI (Omnibus) perceived exercise scale has been shown to be comparable to a heart rate monitor. This design allows the exercise program to be developed and tailored to fit patient tolerance levels but also to fit within the family circumstances and equipment. The gradual resumption of activities is based upon the Return to Sport – General Guidelines and Sport Concussion Return to Play Guidelines. The program includes 4 physiotherapy telehealth/phone calls updating a home program, updated weekly in line with symptoms. Our study will differ from other studies as we will be aiming to complete all sessions via a Tele‐health model without CONDITION: Concussion / Mild Traumatic Brain Injury; ; Concussion / Mild Traumatic Brain Injury Neurological ‐ Other neurological disorders Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: Post Concussion Symptom Inventory (PSCI) change[PSCI ‐ Initial Contact with Nursing Staff (Both sides of RCT); PSCI ‐ Week 1 (Initial Tele‐exercise appointment (Intervention Group); PSCI ‐ Week 5 Either RedCap or Nursing Phone Call (Both sides of RCT)] SECONDARY OUTCOME: 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) ; Week 1 ‐ Initial Tele‐exercise session (intervention Group only) ; Week 5 ‐ Either RedCap or Nursing Phone Call] Pediatric Quality of Life Inventory (PedsQL)[Initial Nursing phone call (both sides of RCT) ; Week 1 ‐ Initial Tele‐exercise session (intervention Group only) ; Week 5 ‐ Either RedCap or Nursing Phone Call ; ] 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
Epistemonikos ID: f962acbe4ac7aedbbfa35c45ed3a4109bdd04609
First added on: Aug 26, 2024