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Fellowship Graduation December 2021
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation plus Physical Therapy | Experimental | Participants in the experimental group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute application of tDCS during each treatment session via the Halo Sport (Halo Neuroscience, San Francisco, CA) headset. 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. |
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| Sham Transcranial Direct Current Stimulation plus Physical Therapy | Sham Comparator | Participants in the sham control group will receive the current standard of care in ankle inversion sprain rehabilitation plus a 20-minute sham tDCS treatment, where the patient is wearing the tDCS headset, but stimulation is only applied for 30 seconds of the 20-minute period. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Pain Rating | Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain | Change from Baseline to 4-weeks |
| Composite Pain Rating | Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain | Change from Baseline to 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Function | Patient report of function assessed by Single Assessment Numeric Evaluation | Change from Baseline to 4-weeks |
| Self-Reported Function | Patient report of function assessed by Single Assessment Numeric Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keller Army Community Hospital - Arvin Physical Therapy | West Point | New York | 10966 | United States |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Sham Transcranial Direct Current Stimulation | Other | 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. |
|
| Physical Therapy | Other | 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. |
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| Change from Baseline to 8-weeks |
| Muscle Strength | Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry | Change from Baseline to 4-weeks |
| Muscle Strength | Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry | Change from Baseline to 8-weeks |
| Proprioception | Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest | Change from Baseline to 4-weeks |
| Proprioception | Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest | Change from Baseline to 8-weeks |
| Dynamic balance | Dynamic balance assessed by the Y-balance Test | Change from Baseline to 4-weeks |
| Dynamic balance | Dynamic balance assessed by the Y-balance Test | Change from Baseline to 8-weeks |
| Muscle Power | Single leg hop test for distance | Change from Baseline to 4-weeks |
| Muscle Power | Single leg hop test for distance | Change from Baseline to 8-weeks |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012046 | Rehabilitation |