Ankle SprainNCT07190599
NMES With PNF for Ankle Sprain Rehabilitation
A study testing Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES) and Proprioceptive neuromuscular facilitation (PNF) only in people with Ankle Sprain, run by Fooyin University at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES) and Proprioceptive neuromuscular facilitation (PNF) only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 31 Jul 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-30 years
- Adults with a history of ankle sprain
Who cannot join
- Participants with ankle fractures, dislocations, grade III ankle sprains, bony restrictions, swelling, neuropathy, or any other neuromuscular disorders are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fooyin University
Kaohsiung City, No. 151, Jinxue Road, Daliao District
I-Hsuan Chen, +886-7-781-1151#7043, Y0894@fy.edu.tw
About this study
Official title: 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.
- Conditions
- Ankle Sprain
- Being tested
- Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES), Proprioceptive neuromuscular facilitation (PNF) only
- Keywords
- Ankle sprain, Balance, Proprioception, Strength, Pain, Range of motion
- Medical subject headings
- Ankle Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES)Behavioural
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.
Proprioceptive neuromuscular facilitation (PNF) onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NMES with PNF | Experimental | The experimental group will receive proprioceptive neuromuscular facilitation (PNF) stretching combined with neuromuscular electrical stimulation (NMES) Receives: Behavioral: Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES) |
| PNF only | Active comparator | The control group will receive PNF stretching only. Receives: Behavioral: Proprioceptive neuromuscular facilitation (PNF) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Star Excursion Balance Test, SEBT
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Proprioception - ankle dorsiflexion (degrees)
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Proprioception - ankle plantarflexion (degrees)
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Muscle strength - ankle dorsiflexors (kg)
A dynamometer (Micro FET3) will be placed on the dorsal surfaces of the metatarsals to measure strength of dorsiflexors.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Muscle strength - ankle plantarflexors (kg)
A dynamometer (Micro FET3) will be placed on the plantar surfaces of the metatarsals to measure strength of plantarflexors.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Range of motion - Ankle dorsiflexion (degrees)
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Range of motion - Ankle plantarflexion (degrees)
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
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Secondary outcomes (3)
The Foot and Ankle Disability Index (FADI)
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Knee to wall test
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Visual analog scale (VAS)
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.
Measured: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190599
- Sponsor's protocol ID
- NCKU HREC-E-114-0093-2
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation Combined With Proprioceptive Neuromuscular Facilitation in Adults With a History of Ankle Sprain
- ClinicalTrials.gov ID
- NCT07190599
- Acronym / sponsor ID
- NCKU HREC-E-114-0093-2
- Conditions
- Ankle Sprain
- Keywords
- Ankle sprain, Balance, Proprioception, Strength, Pain, Range of motion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Sep 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES with PNF | Experimental | Behavioral: Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES)The experimental group will receive proprioceptive neuromuscular facilitation (PNF) stretching combined with neuromuscular electrical stimulation (NMES) |
| PNF only | Active comparator | Behavioral: Proprioceptive neuromuscular facilitation (PNF) onlyThe control group will receive PNF stretching only. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-30 years
- Adults with a history of ankle sprain
Key exclusion criteria (1 listed)
- Participants with ankle fractures, dislocations, grade III ankle sprains, bony restrictions, swelling, neuropathy, or any other neuromuscular disorders are excluded.
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitation (PNF) 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. | Behavioural | NMES with PNF |
| Proprioceptive neuromuscular facilitation (PNF) onlyThe 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. | Behavioural | PNF only |
Primary outcome
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.
Proprioception - ankle dorsiflexion (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.
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.
Muscle strength - ankle dorsiflexors (kg)
Time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
A dynamometer (Micro FET3) will be placed on the dorsal surfaces of the metatarsals to measure strength of dorsiflexors.
Muscle strength - ankle plantarflexors (kg)
Time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
A dynamometer (Micro FET3) will be placed on the plantar surfaces of the metatarsals to measure strength of plantarflexors.
Range of motion - Ankle dorsiflexion (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 dorsiflexion.
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
3 secondary outcomes
The Foot and Ankle Disability Index (FADI)
Time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Knee to wall test
Time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
Visual analog scale (VAS)
Time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)
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 17 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES) and Proprioceptive neuromuscular facilitation (PNF) only in people with Ankle Sprain, run by Fooyin University at 1 site in Taiwan.
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 1 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 17 Nov 2025. 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 Taiwan. 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 I-Hsuan Chen (886-7-7811151 #7043, Y0894@fy.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Star Excursion Balance Test, SEBT (time frame: 1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)). The study lists 7 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 17 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.