Ankle Sprains, Musculoskeletal Injury
Conditions
Brief summary
Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.
Interventions
OTHERTranscranial Direct Current Stimulation
The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the tDCS group will complete a 20-minute tDCS session while performing the warm-up.
OTHERSham Transcranial Direct Current Stimulation
The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the sham tDCS group will complete a 20-minute sham-tDCS session while performing the warm-up, but the app will discontinue the treatment after 30 seconds.
OTHERPhysical Therapy
After the tDCS session is complete, the patient will complete treatment consistent with the standard of care for rehabilitation of acute ankle inversion sprain. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes. Patients will also perform a standardized home exercise program that reinforces the in-clinic treatment.
Sponsors
Keller Army Community Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-40 2. Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain
Exclusion criteria
1. Self-Reported Pregnancy 2. Being treated for and on medication for a mental health diagnosis 3. Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months 4. Open wound or dermatologic lesion on the head or region of application 5. Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.). 6. Epilepsy or history of seizures 7. Participants who are not fluent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Pain Rating | Change from Baseline to 4-weeks | Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Function | Change from Baseline to 4-weeks | Patient report of function assessed by Single Assessment Numeric Evaluation |
| Muscle Strength | Change from Baseline to 4-weeks | Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry |
| Proprioception | Change from Baseline to 4-weeks | Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest |
| Dynamic balance | Change from Baseline to 4-weeks | Dynamic balance assessed by the Y-balance Test |
| Muscle Power | Change from Baseline to 4-weeks | Single leg hop test for distance |
Countries
United States
Outcome results
None listed