NCT06370325

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

April 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

April 12, 2024

Last Update Submit

February 25, 2026

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (6)

  • Isometric Strength of Gastrocnemius Muscle

    Measured using Biodex dynamometer.

    Week 6

  • Isometric Strength of Gastrocnemius Muscle

    Measured using Biodex dynamometer.

    Week 9

  • Isometric Strength of Gastrocnemius Muscle

    Measured using Biodex dynamometer.

    Week 12

  • Bilateral Calf Circumference

    Week 6

  • Bilateral Calf Circumference

    Week 9

  • Bilateral Calf Circumference

    Week 12

Secondary Outcomes (12)

  • Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Week 6

  • Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Week 9

  • Lower Extremity Functional Scale (LEFS) Questionnaire Score

    Week 12

  • Sit-to-Stand Test

    Week 6

  • Sit-to-Stand Test

    Week 9

  • +7 more secondary outcomes

Study Arms (2)

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.

Procedure: VPOD Wireless Tens UnitProcedure: Physical TherapyDevice: Biodex

Control Group

ACTIVE COMPARATOR

Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Procedure: Physical TherapyDevice: Biodex

Interventions

VPOD Wireless Tens UnitPROCEDURE

The VPOD unit will deliver NMES to participants in the Intervention Group.

Intervention Group
Physical TherapyPROCEDURE

Physical therapy as per standard of care.

Control GroupIntervention Group
BiodexDEVICE

Used to assess strength, endurance, power, and range of motion.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable and willing to provide informed consent
  • Undergoing a procedure that involves repairing an ankle fracture.

You may not qualify if:

  • Patients with medical histories that include:
  • Rheumatoid arthritis
  • Connective tissue disorders
  • Chronic corticosteroid use
  • Implanted electrical devices
  • Neurological disorders
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Raymond J. Walls, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond J. Walls, MD

CONTACT

(917) 780-8720Raymond.Walls@nyulangone.org

Thelma Jimenez Mosquea, MD

CONTACT

(347) 880-2254Thelma.JimenezMosquea@nyulangone.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 17, 2024

Study Start

June 19, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data to be used only by the research team.

Locations

US(1)