Ankle SprainsNCT04902274
Effectiveness of Transcranial Direct Current Stimulation (tDCS).
A study testing Transcranial Direct Current Stimulation and Physical Therapy in people with Ankle Sprains and Musculoskeletal Injury, run by Keller Army Community Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Sprains, Musculoskeletal Injury
- What is being tested?
- Transcranial Direct Current Stimulation and Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40
- Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain
Who cannot join
- Self-Reported Pregnancy
- Being treated for and on medication for a mental health diagnosis
- Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
- Open wound or dermatologic lesion on the head or region of application
- Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
- Epilepsy or history of seizures
- Participants who are not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital - Arvin Physical Therapy
West Point, New York, 10966
About this study
Official title: Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.
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.
- Conditions
- Ankle Sprains, Musculoskeletal Injury
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, Physical Therapy
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
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.
Sham Transcranial Direct Current StimulationOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transcranial Direct Current Stimulation; Other: Physical Therapy |
| 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. Receives: Other: Sham Transcranial Direct Current Stimulation; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Pain Rating
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Measured: Change from Baseline to 4-weeks
Composite Pain Rating
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Measured: Change from Baseline to 8-weeks
Secondary outcomes (10)
Self-Reported Function
Patient report of function assessed by Single Assessment Numeric Evaluation
Measured: Change from Baseline to 4-weeks
Self-Reported Function
Patient report of function assessed by Single Assessment Numeric Evaluation
Measured: Change from Baseline to 8-weeks
Muscle Strength
Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry
Measured: Change from Baseline to 4-weeks
Muscle Strength
Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry
Measured: Change from Baseline to 8-weeks
Proprioception
Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest
Measured: Change from Baseline to 4-weeks
Proprioception
Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest
Measured: Change from Baseline to 8-weeks
Dynamic balance
Dynamic balance assessed by the Y-balance Test
Measured: Change from Baseline to 4-weeks
Dynamic balance
Dynamic balance assessed by the Y-balance Test
Measured: Change from Baseline to 8-weeks
Muscle Power
Single leg hop test for distance
Measured: Change from Baseline to 4-weeks
Muscle Power
Single leg hop test for distance
Measured: Change from Baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start19 Aug 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: Fellowship Graduation December 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902274
- Sponsor's protocol ID
- 19KACH005
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.
- ClinicalTrials.gov ID
- NCT04902274
- Acronym / sponsor ID
- 19KACH005
- Conditions
- Ankle Sprains, Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Fellowship Graduation December 2021
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation plus Physical Therapy | Experimental | Other: Transcranial Direct Current Stimulation, Other: Physical TherapyParticipants 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. |
| Sham Transcranial Direct Current Stimulation plus Physical Therapy | Sham comparator | Other: Sham Transcranial Direct Current Stimulation, Other: Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-40
- Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain
Key exclusion criteria (7 listed)
- Self-Reported Pregnancy
- Being treated for and on medication for a mental health diagnosis
- Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
- Open wound or dermatologic lesion on the head or region of application
- Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationThe 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. | Other | Transcranial Direct Current Stimulation plus Physical Therapy |
| Sham Transcranial Direct Current StimulationThe 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. | Other | Sham Transcranial Direct Current Stimulation plus Physical Therapy |
| Physical TherapyAfter 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. | Other | Sham Transcranial Direct Current Stimulation plus Physical Therapy, Transcranial Direct Current Stimulation plus Physical Therapy |
Primary outcome
Composite Pain Rating
Time frame: Change from Baseline to 4-weeks
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
Composite Pain Rating
Time frame: Change from Baseline to 8-weeks
Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain
10 secondary outcomes
Self-Reported Function
Time frame: Change from Baseline to 4-weeks
Self-Reported Function
Time frame: Change from Baseline to 8-weeks
Muscle Strength
Time frame: Change from Baseline to 4-weeks
Muscle Strength
Time frame: Change from Baseline to 8-weeks
Proprioception
Time frame: Change from Baseline to 4-weeks
Proprioception
Time frame: Change from Baseline to 8-weeks
Dynamic balance
Time frame: Change from Baseline to 4-weeks
Dynamic balance
Time frame: Change from Baseline to 8-weeks
Muscle Power
Time frame: Change from Baseline to 4-weeks
Muscle Power
Time frame: Change from Baseline to 8-weeks
Results and safety
The study was stopped early (reason given: Fellowship Graduation December 2021). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Physical Therapy in people with Ankle Sprains and Musculoskeletal Injury, run by Keller Army Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Fellowship Graduation December 2021). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Pain Rating (time frame: Change from Baseline to 4-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.