Evaluation of a Physical Intervention for Persistent Post-Concussive Symptoms

NCT03357042 | Withdrawn

• 1 other identifier: RP-506-07112017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A concussion occurs when a person receives an impact to the head. The most common persistent symptoms that generate from a concussion are headaches, depression, lack of balance and dizziness. One recommendation to alleviate persistent symptoms of concussion is rest. Research findings indicate that the benefit of rest is inconclusive to help individuals suffering from a concussion return to activities of daily living. One treatment approach in reducing concussion symptoms is physical exercise therapy. Research findings, however, are limited to treatments being administered before the symptoms are considered persistent. Based on this rationale, the aim of this study is to examine the effect of a physical therapy intervention in minimizing persistent symptoms of concussion using measures of cognition and brain function, mental and physical health, and driving performance. If successful, this physical therapy intervention may help treat persistent concussion symptoms, improving the quality of life and ability for individuals to function normally in their daily lives, and resulting in savings to the healthcare system

Conditions

Persistent Post-Concussive Syndrome

Outcome Measures

Primary Outcomes (6)

• Star Excursion Balance Test (SEBT)

  Measure of balance. Score is based on normalized percentage of maximum reach distance (0-100%) with 100% equal to a perfect score.

  8 weeks

• Immediate Post-Concussion Assessment Battery

  Cognitive assessment-Composite score is generated from each subscale by averaging scores, with 100 being equal to a perfect score.

  8 weeks

• Driving simulator

  Reaction time to several scenarios will be measured

  8 weeks

• Oddball task

  Number of event related potentials will be measured during responses to stimuli

  8 weeks

• Flanker task

  Number of event related potentials will be measured during responses to stimuli

  8 weeks

• Brain-derived neurotropic factor

  Saliva will be used to analyze brain-derived neurotropic factor

  8 weeks

Study Arms (2)

Persistent post-concussive symptoms

EXPERIMENTAL

Participants who report post-concussive symptoms. 20 participants will receive the aerobic exercise and balance training intervention, 20 participants will receive standard of care treatment for concussions.

Other: Aerobic exercise and balance retraining; Other: Standard of care

Healthy control

ACTIVE COMPARATOR

Persons without post-concussive symptoms. No intervention.

Other: Standard of care

Interventions

Aerobic exercise and balance retraining OTHER

Aerobic and balance exercises that gradually progress in intensity over the course of 8 weeks.

Persistent post-concussive symptoms

Standard of care OTHER

Normal concussion treatment; physical and cognitive rest

Healthy control; Persistent post-concussive symptoms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman aged 18-50 years.
• Reports at least one PCS symptom that is mild in severity.
• It has been two weeks since date of injury.

You may not qualify if:

• Has been previously diagnosed with a psychological/neurological disorder
• Has been previously diagnosed with a substance abuse disorder/impairment,
• Is currently seeking therapy/counseling
• Does not have valid driver's license and 12 months of driving experience.

Sponsors & Collaborators

• Lakehead University: lead
• Northern Ontario School of Medicine: collaborator

Study Sites (1)

Fairway Physiotherapy

Thunder Bay, Ontario, P7B 5E1, Canada

Location

MeSH Terms

Interventions

Exercise; Standard of Care

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sheryl Wark, M.D.

  Northern Ontario School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three group: Aerobic retraining intervention, standard of care intervention, healthy control

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 29, 2017
• Study Start: March 8, 2018
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: June 1, 2020

Record last verified: 2019-08

Locations

CA (1)