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
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