Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms

NCT06069700 | Completed

• 1 other identifier: 22-5560
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol Summary The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ. Sample Size: N= 50 Study Population Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; have a chronic infectious disease; uncontrolled hypertension; other neurological disorders (not attributed to their primary diagnosis); cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities; those with pacemakers or elevated cardiovascular risk; ongoing litigation surrounding their injury; have been diagnosed with a moderate or severe brain injury prior to enrolment; post-concussive symptoms persisting beyond 12-months. Study Design The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations. Start Date: May 2023 End Date: September 2025 Primary Objective: The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.

Conditions

Postconcussion Syndrome; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Rivermead Postconcussion Questionnaire

  The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI). Each item is rated on a 5-point ordinal scale: 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. The total score is a sum of all items and ranges from 0 to 64 from (best to worst).

  Baseline; 6-weeks; 12-weeks

Secondary Outcomes (3)

• Brain Vital Sign

  Baseline; 6-weeks; 12-weeks

• Patient Health Questionnaire (PHQ-9)

  Baseline; 6-weeks; 12-weeks

• Neck Disability Index (NDI)

  Baseline; 6-weeks; 12-weeks

Study Arms (2)

Individualized care program

EXPERIMENTAL

Participants in the individualized care stream, will be provided reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms consistent with usual care. Additionally, they will be afforded up to 12 treatments over the course of 6-weeks. Treatments will be standardized; however, given the heterogeneity of symptoms, components of the treatments will be individualized to the participants based on what subgroup they're classified into at baseline based on their initial clinical examination and self-reported dominant impairment. Regardless of subgroup classification, as part of individualized care, all patients will receive reassurance and psychoeducation about the bio-psycho-social understanding of persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour".

Other: Non-pharmacological Individualized rehabilitative therapy

Usual care

ACTIVE COMPARATOR

Active control - All participants in the active control group will receive 'usual care', (twice a week for 6 weeks), which will consist of reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour". Additionally, participants will be afforded weekly 20-minute supervised progressive sub-symptom aerobic exercise sessions at the KITE clinic under the supervision of study coordinator. They will be instructed to also perform daily 20-minutes of subsymptom aerobic exercise outside the supervised exercise sessions.

Other: Non-pharmacological Usual care therapy

Interventions

Non-pharmacological Individualized rehabilitative therapy OTHER

Treatments will be standardized but components of the treatments will be individualized to the participants based on what subgroup they're classified into at baseline based on their initial clinical examination and self-reported dominant impairment. \*Physiological group - Participants will receive supervised sub-symptom aerobic exercise 20-minutes twice per week and mindfulness-based training 20-minutes twice per week. \*Cervical group - Participants will receive physical therapy to the cervical spine. Physical therapy will include soft tissue therapy directed to the cervical myofascial tissues, and graded cervical spine facet mobilizations. \*Vestibulo-Ocular group - Patients classified to vestibulo-ocular subgroup will receive bi-weekly 30-minute individualized oculomotor, vestibular and balance exercises including adaptation exercises, gaze stability exercises, visual-vestibular integration exercises, habituation exercises, static and dynamic balance exercises.

Individualized care program

Non-pharmacological Usual care therapy OTHER

All participants in the active control group will receive 'usual care', (twice a week for 6 weeks), which will consist of reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour". Additionally, participants will be afforded weekly 20-minute supervised progressive sub-symptom aerobic exercise sessions at the KITE clinic under the supervision of study coordinator NM. They will be instructed to also perform daily 20-minutes of subsymptom aerobic exercise outside the supervised exercise sessions.

Usual care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more (from an inclusive list of 40 most commonly reported persisting symptoms) lasting at least 1-month following the diagnosis of a concussion. Concussion was defined according to the 5th International Consensus Statement on Concussion in Sport.
• Have adequate language skills in English to read and take part in rehabilitation treatment program.

You may not qualify if:

• In-patients at Toronto Rehabilitation Institute or any other affiliated University Health Network clinics.
• Participants will be excluded should their clinical examination be unremarkable for objective physical impairments,
• Have a chronic infectious disease,
• Uncontrolled hypertension,
• Other neurological disorders (not attributed to their primary diagnosis),
• Cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities, those with pacemakers or elevated cardiovascular risk,
• Ongoing litigation surrounding their injury,
• Have been diagnosed with a moderate or severe brain injury prior to enrolment, post-concussive symptoms persisting beyond 12-months.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• NeuroCatch Inc.: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (1)

• Moser N, Popovic MR, Kalsi-Ryan S. Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol. BMC Neurol. 2024 Jul 10;24(1):239. doi: 10.1186/s12883-024-03700-5.

  PMID: 38987676 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Milos R Popovic, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cas-crossover clinical trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 6, 2023
• Study Start: January 30, 2023
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)