- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07190599
- Original Trial
NMES With PNF for Ankle Sprain Rehabilitation
November 14, 2025 updated by: Fooyin University
Effects of Neuromuscular Electrical Stimulation Combined With Proprioceptive Neuromuscular Facilitation in Adults With a History of Ankle Sprain
Ankle sprains are one of the most common sports injuries.
In some people, they can lead to chronic ankle problems that affect daily life and sports performance.
In this study, we want to see if combining neuromuscular electrical stimulation (NMES) with proprioceptive neuromuscular facilitation (PNF) can help improve these problems.
We plan to recruit 60 participants, with 30 in the experimental group and 30 in the control group.
The experimental group will receive PNF stretching with NMES, while the control group will only do PNF stretching.
Both groups will have training three times a week for four weeks (12 sessions in total).
We will test participants before and after the program, looking at pain, balance, range of motion, proprioception, strength, joint mobility, and functional limitations.
We expect that 12 sessions will help improve chronic ankle problems, and that NMES combined with PNF will be more effective than PNF alone.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: I-Hsuan Chen
- Phone Number: 886-7-7811151 #7043
- Email: Y0894@fy.edu.tw
Study Locations
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No. 151, Jinxue Road, Daliao District
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Kaohsiung City, No. 151, Jinxue Road, Daliao District, Taiwan
- Recruiting
- Fooyin University
-
Contact:
- I-Hsuan Chen
- Phone Number: +886-7-781-1151#7043
- Email: Y0894@fy.edu.tw
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18-30 years
- Adults with a history of ankle sprain
Exclusion Criteria:
- Participants with ankle fractures, dislocations, grade III ankle sprains, bony restrictions, swelling, neuropathy, or any other neuromuscular disorders are excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NMES with PNF
The experimental group will receive proprioceptive neuromuscular facilitation (PNF) stretching combined with neuromuscular electrical stimulation (NMES)
|
The NMES was applied during the plantarflexor contraction phase of the PNF stretching (described as below).
Two electrodes (4 × 8 cm) were used for stimulation, placed on the triceps surae of the affected side: one positioned 5 cm below the popliteal fossa, and the other placed 5 cm below the first electrode, directly over the triceps surae.
The hold-relax technique of proprioceptive neuromuscular facilitation (PNF) will be applied to stretch the triceps surae muscle.
It will be performed ten times on the affected limb during each treatment session, lasting approximately 10 minutes in total.
Participants will receive interventions three times per week for four weeks, for a total of twelve sessions.
|
|
Active Comparator: PNF only
The control group will receive PNF stretching only.
|
The hold-relax technique will be applied to stretch the triceps surae muscle.
It will be performed ten times on the affected limb during each treatment session, lasting approximately 10 minutes in total.
Participants will receive interventions three times per week for four weeks, for a total of twelve sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Star Excursion Balance Test, SEBT
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
|
Balance ability will be assessed using the Star Excursion Balance Test (SEBT).
Participants stand barefoot at the center of a grid with eight lines extending at 45° angles.
They are instructed to reach with the distal part of the foot to touch the farthest point along each line while maintaining a standing position.
The examiner recorded the reached distance in centimeters, measured from the center of the grid to the point touched by the participant's big toe.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Proprioception - ankle dorsiflexion (degrees)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Proprioception of the affected ankle will be measured using the Micro FET3 inclinometer.
The examiner moves the foot to a target angle (hold for 10 seconds), and then returned to the starting position.
Participants then actively reproduces the angle.
The difference between the target and reproduced angles represented proprioceptive accuracy.
|
1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Proprioception - ankle plantarflexion (degrees)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
|
Proprioception of the affected ankle will be measured using the Micro FET3 inclinometer.
The examiner moves the foot to a target angle (hold for 10 seconds), and then returned to the starting position.
Participants then actively reproduces the angle.
The difference between the target and reproduced angles represented proprioceptive accuracy.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Muscle strength - ankle dorsiflexors (kg)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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A dynamometer (Micro FET3) will be placed on the dorsal surfaces of the metatarsals to measure strength of dorsiflexors.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Muscle strength - ankle plantarflexors (kg)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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A dynamometer (Micro FET3) will be placed on the plantar surfaces of the metatarsals to measure strength of plantarflexors.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Range of motion - Ankle dorsiflexion (degrees)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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The axis of the goniometer was placed at the lateral malleolus, the stationary arm aligned with the lateral fibula, and the moving arm aligned with the fifth metatarsal.
Participants will be instructed to actively move the ankle from 0° starting position to maximal dorsiflexion.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Range of motion - Ankle plantarflexion (degrees)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
|
The axis of the goniometer was placed at the lateral malleolus, the stationary arm aligned with the lateral fibula, and the moving arm aligned with the fifth metatarsal.
Participants will be instructed to actively move the ankle from 0° starting position to maximal plantarflexion
|
1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Foot and Ankle Disability Index (FADI)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
|
Functional limitations will be assessed using the Foot and Ankle Disability Index (FADI).
The FADI includes 22 questions related to functional activities and 4 questions related to pain.
Each item is scored from 0 (unable to do) to 4 (no difficulty), with a maximum total score of 104, which is then converted to a percentage.
A score of 100% indicates no functional limitation.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Knee to wall test
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Participants stand facing a wall with their toes about 10 cm away.
The non-affected foot steps back, and the affected knee bends forward to touch the wall while keeping the heel on the ground.
If the knee cannot reach the wall, the front foot moves closer.
The distance from the affected big toe to the wall is then measured.
The distance (cm) from the participant's big toe of the affected foot to the wall was measured and recorded.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Visual analog scale (VAS)
Time Frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Participants mark their pain level on a 10-cm line, with the left end representing 'no pain' and the right end representing 'unbearable pain.'
The mark indicates the intensity of their pain.
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1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
September 17, 2025
First Submitted That Met QC Criteria
September 17, 2025
First Posted (Estimated)
September 24, 2025
Study Record Updates
Last Update Posted (Actual)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Wounds and Injuries
- Leg Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Ankle Injuries
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Socioeconomic Factors
- Population Characteristics
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Demography
- Exercise
- Family Characteristics
- Marital Status
- Muscle Stretching Exercises
- Single Person
Other Study ID Numbers
- NCKU HREC-E-114-0093-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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