Ankle FracturesNCT06370325
Neuromuscular Electrical Stimulation in Foot and Ankle Surgery
A study testing VPOD Wireless Tens Unit, Physical Therapy and Biodex in people with Ankle Fractures, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- VPOD Wireless Tens Unit, Physical Therapy and Biodex
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable and willing to provide informed consent
- Undergoing a procedure that involves repairing an ankle fracture.
Who cannot join
- Patients with medical histories that include:
- Rheumatoid arthritis
- Connective tissue disorders
- Chronic corticosteroid use
- Implanted electrical devices
- Neurological disorders
Show all 15Show fewer
- Non-ambulatory status
- Recent surgery (within the last 3 months) that is not related to the study
- Scheduled to undergo surgery in the near future
- Epilepsy
- Diagnosed with cancer
- Have suffered acute trauma or recently have had a surgical procedure (not related to the study)
- Have cardiac problems or cardiac disease
- Have an abdominal hernia
- Have venous thrombosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale [LEFS]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.
- Conditions
- Ankle Fractures
- Being tested
- VPOD Wireless Tens Unit, Physical Therapy, Biodex
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPOD Wireless Tens UnitProcedure or surgery
The VPOD unit will deliver NMES to participants in the Intervention Group.
Physical TherapyProcedure or surgery
Physical therapy as per standard of care.
BiodexDevice
Used to assess strength, endurance, power, and range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomized to the intervention group will undergo neuromuscular electrical stimulation (NMES) five days a week beginning three weeks postoperative and lasting for ten weeks. The intervention group will begin standard physical therapy at six weeks postoperative. Receives: Procedure: VPOD Wireless Tens Unit; Procedure: Physical Therapy; Device: Biodex |
| Control Group | Active comparator | Participants randomized to the control group will begin standard physical therapy at six weeks postoperative. Receives: Procedure: Physical Therapy; Device: Biodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Measured: Week 6
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Measured: Week 9
Isometric Strength of Gastrocnemius Muscle
Measured using Biodex dynamometer.
Measured: Week 12
Bilateral Calf Circumference
Measured: Week 6
Bilateral Calf Circumference
Measured: Week 9
Bilateral Calf Circumference
Measured: Week 12
Secondary outcomes (12)
Lower Extremity Functional Scale (LEFS) Questionnaire Score
LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.
Measured: Week 6
Lower Extremity Functional Scale (LEFS) Questionnaire Score
LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.
Measured: Week 9
Lower Extremity Functional Scale (LEFS) Questionnaire Score
LEFS is a 20-item questionnaire assessing functional impairment in patients with disorders affecting one or both lower extremities. Each item is rated on a scale ranging from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates considerable difficulty, 2 indicates moderate difficulty, 3 indicates slight difficulty, and 4 indicates no difficulty. The score is the sum of responses and ranges from a minimum of 0 to a maximum of 80, with lower scores indicating greater disability.
Measured: Week 12
Sit-to-Stand Test
The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.
Measured: Week 6
Sit-to-Stand Test
The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.
Measured: Week 9
Sit-to-Stand Test
The sit-to-stand test involves recording the number of stands a person can complete in 30 seconds.
Measured: Week 12
2 Minute Walk Test
In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured
Measured: Week 6
2 Minute Walk Test
In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured
Measured: Week 9
2 Minute Walk Test
In this activity, the participant is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured
Measured: Week 12
Stair Climb Test
The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.
Measured: Week 6
Stair Climb Test
The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.
Measured: Week 9
Stair Climb Test
The stair climb test measures the amount of time a person ascends and descends a flight of stairs, while walking as quickly as they feel safe and comfortable to move.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond J. Walls, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370325
- Sponsor's protocol ID
- 23-00987
- Status last verified
- Feb 2026
- First submitted
- 12 Apr 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data to be used only by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation in Foot and Ankle Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT06370325
- Acronym / sponsor ID
- 23-00987
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Apr 2024 (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.
This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale [LEFS]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: VPOD Wireless Tens Unit, Procedure: Physical Therapy, Device: BiodexParticipants randomized to the intervention group will undergo neuromuscular electrical stimulation (NMES) five days a week beginning three weeks postoperative and lasting for ten weeks. The intervention group will begin standard physical therapy at six weeks postoperative. |
| Control Group | Active comparator | Procedure: Physical Therapy, Device: BiodexParticipants randomized to the control group will begin standard physical therapy at six weeks postoperative. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Capable and willing to provide informed consent
- Undergoing a procedure that involves repairing an ankle fracture.
Key exclusion criteria (15 listed)
- Rheumatoid arthritis
- Connective tissue disorders
- Chronic corticosteroid use
- Implanted electrical devices
- Neurological disorders
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 |
|---|---|---|
| VPOD Wireless Tens UnitThe VPOD unit will deliver NMES to participants in the Intervention Group. | Procedure or surgery | Intervention Group |
| Physical TherapyPhysical therapy as per standard of care. | Procedure or surgery | Control Group, Intervention Group |
| BiodexUsed to assess strength, endurance, power, and range of motion. | Device | Control Group, Intervention Group |
Primary outcome
Isometric Strength of Gastrocnemius Muscle
Time frame: Week 6
Measured using Biodex dynamometer.
Isometric Strength of Gastrocnemius Muscle
Time frame: Week 9
Measured using Biodex dynamometer.
Isometric Strength of Gastrocnemius Muscle
Time frame: Week 12
Measured using Biodex dynamometer.
Bilateral Calf Circumference
Time frame: Week 6
Bilateral Calf Circumference
Time frame: Week 9
Bilateral Calf Circumference
Time frame: Week 12
12 secondary outcomes
Lower Extremity Functional Scale (LEFS) Questionnaire Score
Time frame: Week 6
Lower Extremity Functional Scale (LEFS) Questionnaire Score
Time frame: Week 9
Lower Extremity Functional Scale (LEFS) Questionnaire Score
Time frame: Week 12
Sit-to-Stand Test
Time frame: Week 6
Sit-to-Stand Test
Time frame: Week 9
Sit-to-Stand Test
Time frame: Week 12
2 Minute Walk Test
Time frame: Week 6
2 Minute Walk Test
Time frame: Week 9
2 Minute Walk Test
Time frame: Week 12
Stair Climb Test
Time frame: Week 6
Stair Climb Test
Time frame: Week 9
Stair Climb Test
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Data to be used only by the research team.
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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.
Raymond J. Walls, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPOD Wireless Tens Unit, Physical Therapy and Biodex in people with Ankle Fractures, run by NYU Langone Health 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 15 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond J. Walls, MD ((917) 780-8720, Raymond.Walls@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Strength of Gastrocnemius Muscle (time frame: Week 6). The study lists 6 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 27 Feb 2026.