Concussion Clinical Profiles Screening (CP Screen) Tool: Preliminary Evidence to Inform a Multidisciplinary Approach.
Anthony P Kontos, R J Elbin, Alicia Trbovich...
https://pubmed.ncbi.nlm.nih.gov/31950187/Actively Recruiting
Led by Oregon Health and Science University · Updated on 2025-10-14
100
Participants Needed
3
Research Sites
N/A
Total Duration
Researchers are evaluating the use of wearable sensors to assess and treat people with mild traumatic brain injury mTBI, focusing especially on balance and movement problems common after concussion. The study aims to improve rehabilitation by providing immediate visual andor auditory feedback on movement quality during physical therapy, compared to standard vestibular rehabilitation. This approach targets specific mTBI subtypes affecting balance and vision and seeks to help patients return safely to high-level activities such as military duty. Participants will be randomly assigned to one of two groups one receiving vestibular therapy enhanced with real-time audio and visual biofeedback from sensors placed on the head, chest, waist, and feet, and the other receiving standard vestibular therapy without biofeedback. Both groups will complete 12 therapy sessions over 6 weeks, with sessions twice a week. A subset of participants will also wear instrumented socks for 7 days to monitor daily life mobility, alongside healthy military members for comparison. During the study, participants will undergo various assessments before and after therapy, including patient-reported outcomes, clinical tests, and instrumented measures of balance, gait, and vision. The main measure is the Patient Global Impression of Change after 8 weeks. Researchers will also analyze responses by subtype severity and collect detailed mobility data. Safety risks include possible symptom increase and fall risk. The total study duration for each participant includes 6 weeks of therapy plus follow-up assessments.
CONDITIONS
Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
L
Laurie A King, PhD, PT, MCR
M
Maggie E Stojak, MS
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Oregon Health and Science University
Lead Sponsor
United States Department of Defense
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Vestibular Therapy with Wearable Biofeedback | Standard Vestibular Therapy |
|---|---|---|
| What is it? | Structured vestibular rehabilitation for balance issues after mTBI, using real-time audio and visual biofeedback delivered via wearable movement sensors during therapy sessions. | Structured vestibular rehabilitation therapy targeting balance and dizziness after mTBI, delivered without the use of audio or visual biofeedback, reflecting current standard practice. |
| Role in the trial | Investigational intervention being tested for added benefit over standard vestibular rehabilitation. | Active control group receiving best-standard vestibular rehabilitation, serving as the clinical benchmark. |
| Primary use or therapeutic goal | To improve balance, dizziness, and related symptoms following mild traumatic brain injury using enhanced therapist-guided exercises informed by sensor feedback. | To restore or improve balance and reduce vestibular-related symptoms after mTBI using established vestibular therapy methods, without technology-assisted feedback. |
| How it is given or performed | Therapists provide individualized vestibular exercise sessions while the participant wears sensors on the head, chest, waist, and feet. Real-time audio and visual cues are delivered to guide and adjust exercise performance. | Therapists lead patients through standard vestibular exercises and balance training, relying on clinical observation and patient symptoms, without technology-provided feedback. |
| Evidence status | Effectiveness for this specific biofeedback system as an adjunct to vestibular therapy for post-mTBI balance issues is not yet established. Systematic reviews suggest wearable biofeedback can enhance balance outcomes in neurological populations, but evidence in mTBI is limited and the trial remains ongoing. | Strong published evidence and guidelines support standard vestibular rehabilitation as effective for improving balance and dizziness in adults after brain injury, including concussion and mTBI. |
| Important limitations | Benefit of wearable biofeedback in mTBI is not yet proven, and optimal protocols or patient selection remain to be established. Sensor cost, technology learning curve, and accessibility may limit real-world use. | Therapeutic gains depend on patient adherence, therapist expertise, and individualized progression. Some cases of persistent symptoms or severe balance issues may require specialized approaches beyond standard therapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants undergo vestibular therapy for mild traumatic brain injury over 6 weeks, with 12 sessions of physical therapy twice a week. Some participants receive real-time audio and visual biofeedback using wearable sensors during therapy, while others receive standard vestibular therapy without biofeedback.
12 sessions (in-person) over 6 weeks
Duration - 2 weeks
Participants are assessed after completing the rehabilitation program to evaluate changes using various clinical and instrumented measures.
1 visit (in-person) at Week 8
Duration - 7 days
A subset of participants wear instrumented socks to monitor daily life mobility and gait quality over 7 days in their normal environment.
7 days of continuous wearable sensor monitoring
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
United States Department of Defense
Collaborating Sponsor