NCT07190599

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress72%
Oct 2025Jul 2026

First Submitted

Initial submission to the registry

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

November 17, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 17, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Ankle sprainBalanceProprioceptionStrengthPainRange of motion

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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

    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)

    1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)

  • Knee to wall test

    1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)

  • Visual analog scale (VAS)

    1. Baseline (Day 1, prior to intervention) 2. Post-intervention (after 12 sessions, Week 4)

Study Arms (2)

NMES with PNF

EXPERIMENTAL

The experimental group will receive proprioceptive neuromuscular facilitation (PNF) stretching combined with neuromuscular electrical stimulation (NMES)

Behavioral: Proprioceptive neuromuscular facilitation (PNF) with neuromuscular electrical stimulation (NMES)

PNF only

ACTIVE COMPARATOR

The control group will receive PNF stretching only.

Behavioral: Proprioceptive neuromuscular facilitation (PNF) only

Interventions

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.

NMES with PNF

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.

PNF only

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-30 years
  • Adults with a history of ankle sprain

You may not qualify if:

  • Participants with ankle fractures, dislocations, grade III ankle sprains, bony restrictions, swelling, neuropathy, or any other neuromuscular disorders are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fooyin University

Kaohsiung City, No. 151, Jinxue Road, Daliao District, Taiwan

RECRUITING

MeSH Terms

Conditions

Ankle InjuriesPain

Interventions

Muscle Stretching ExercisesSingle Person

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

October 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

November 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations