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Chronic Ankle Instability, CAISHACNCT07606534

Ankle vs. Hip vs. Combined Strengthening in Chronic Ankle Instability

A study testing Isometric Ankle Strengthening Program, Hip Strengthening and Combined Isometric Ankle and Hip Strengthening Program in people with Chronic Ankle Instability, CAI and Ankle Sprain, run by University of Liege at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic ankle instability (CAI) is a common condition that can develop after a lateral ankle sprain. Up to 40% of people who sprain their ankle experience a recurrence within a year, and as many as 30% develop persistent symptoms such as ankle "giving way," weakness, or instability. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Chronic Ankle Instability, CAI, Ankle Sprain
What is being tested?
Isometric Ankle Strengthening Program, Hip Strengthening and Combined Isometric Ankle and Hip Strengthening Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteBelgium
Study dates
2 Mar 2026to Sep 2027
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 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Have a history of at least one major ankle sprain that occurred at least 12 months prior to enrolment in the study, was associated with inflammatory symptoms (pain, swelling, etc), created at least one interrupted day of desired physical activity.
  • Have had at least two episodes of feeling like an "unstable" ankle in the six months preceding the study.
  • The Cumberland Ankle Instability Tool (CAIT) with a score of less than 24.
  • The Foot and Ankle Ability Measure (FAAM) Sport scale with a score below 80%.
  • Between 18 and 35 years old
  • Must be able to understand the study procedures and provide written informed consent

Who cannot join

  • Have had a recent injury of less than three months prior to enrolment in the study.
  • A history of surgery on the musculoskeletal structures of the lower limbs.
  • Have a history of fracture of one of the lower limbs requiring realignment.
  • Being diagnosed with a neuromuscular disease.
  • The appearance of swelling or pain in the lower limb during the experiment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aude Aguilaniu Aude, PhD contact

+32483421291

aude.aguilaniu@uliege.be

Belgium1 site, 1 recruiting
  • University of Liege

    Liège, 4000

    Aude Aguilaniu, aude.aguilaniu@uliege.be

    Recruiting

Other trials in Belgium

About this study

Official title: Ankle vs. Hip vs. Combined Strengthening in Chronic Ankle Instability: A Randomized Controlled Trial

Chronic ankle instability (CAI) is a common condition that can develop after a lateral ankle sprain. Up to 40% of people who sprain their ankle experience a recurrence within a year, and as many as 30% develop persistent symptoms such as ankle "giving way," weakness, or instability. These symptoms can limit daily activities, sports participation, and increase the risk of future sprains. Muscle weakness in both the ankle and hip has been identified as an important factor contributing to CAI. Strengthening these muscles may therefore help improve stability and function.

The SHAC study is a randomized controlled trial designed to compare three different strengthening programs in people with chronic ankle instability: (1) an ankle-focused strengthening program, (2) a hip-focused strengthening program, and (3) a combined ankle-hip strengthening program. The goal is to determine which approach leads to the greatest improvement in functional ability, muscle strength, balance, and ankle mobility.

Read more

A total of 45 participants aged 18 to 35 years with documented chronic ankle instability will be recruited from local sports clubs and the University of Liège. All participants must have a history of at least one ankle sprain that occurred more than 12 months before entering the study, report episodes of ankle instability in the previous six months, and meet specific questionnaire criteria (CAIT < 24 and FAAM Sport < 80%). People with recent injuries, previous lower-limb surgery, fractures requiring realignment, neuromuscular conditions, or current pain or swelling will not be able to participate.

After the first assessment (T1), participants will be randomly assigned to one of the three groups. Each intervention lasts four weeks and includes three supervised sessions per week. All strengthening exercises are isometric, performed using a handheld dynamometer to measure force accurately. The ankle program includes plantarflexion, dorsiflexion, inversion, and eversion exercises. The hip program includes clamshells, hip external rotation, abduction, and extension. The combined group alternates between hip and ankle exercises. A warm-up and standardized familiarization are performed before each session.

All participants will attend two additional assessment sessions: one immediately after the four-week program (T2) and one at a later follow-up time point (T3). During each visit, they will complete functional questionnaires, report their sports participation, and undergo several strength and performance tests. These include hip and ankle muscle strength measurements using a dynamometer, the Heel Rise Test, the modified Y-Balance Test, the Side Hop Test, and a dorsiflexion mobility test.

The study aims to identify whether one of the strengthening approaches leads to better functional outcomes for individuals with chronic ankle instability. Understanding these effects may help clinicians design more effective rehabilitation programs for people recovering from ankle sprains and for those experiencing ongoing instability.

Participant data will be kept confidential and stored securely in anonymized form for 20 years. Participation is voluntary, and individuals may withdraw at any time without consequences. Results will be presented anonymously in scientific publications and conferences.

Read the detailed description

Chronic ankle instability (CAI) is a multifactorial condition resulting from a previous lateral ankle sprain and characterized by repeated episodes of ankle "giving way," recurrent sprains, and persistent functional impairment. While the condition is common among active individuals, its underlying mechanisms remain complex. According to the contemporary model proposed by Hertel and Corbett, CAI results from a combination of pathomechanical, sensory-perceptual, and motor-behavior deficits. Among these components, weakness of muscles surrounding both the ankle and the hip has been consistently identified as a contributing factor to impaired neuromuscular control and reduced ability to maintain postural stability during functional activities. Several studies have reported deficits in both ankle and proximal hip strength in individuals with CAI, suggesting that rehabilitation strategies should not limit their focus to the ankle alone.

This clinical study seeks to deepen the understanding of how targeted strengthening influences functional recovery in CAI. Specifically, the trial compares the effects of three distinct strengthening interventions: an ankle-specific isometric training program, a hip-specific isometric training program, and a combined ankle-hip training program. The choice to integrate hip musculature into rehabilitation is grounded in evidence demonstrating that proximal weakness, particularly in abductors and external rotators, can alter lower-limb kinematics and increase susceptibility to recurrent ankle injury. Conversely, strengthening these muscles may enhance dynamic alignment and reduce excessive inversion moments during weight-bearing tasks.

Rationale for the Intervention Isometric exercise was selected as the primary strengthening modality. Compared with isotonic or plyometric training, isometric contractions provide a high-intensity stimulus with minimal joint motion and limited mechanical stress. This is particularly relevant for individuals recovering from instability episodes, as it reduces the likelihood of symptom exacerbation. Isometric training has also been shown to produce rapid neuromuscular adaptations in untrained individuals, even over short intervention periods. By normalizing intensity to each participant's maximal voluntary contraction (MVC), the protocol ensures individualized and progressive overload across sessions without altering the structure of the training program.

Since CAI is partly characterized by impaired motor control, an intervention capable of enhancing maximal force production, reducing neural inhibition, and improving joint stiffness may contribute to better stability. The comparison between isolated ankle strengthening, isolated hip strengthening, and their combination will help clarify whether proximal strengthening alone can meaningfully influence CAI-related impairments, whether local strengthening remains essential, or whether a combined approach provides synergistic effects.

Study Design and Methodological Considerations This randomized controlled trial is conducted at the University of Liège and includes three participant visits in addition to the training sessions. The assessments encompass functional, strength-based, and mobility-related measures relevant to CAI. All testing procedures follow standardized protocols to ensure high reproducibility.

Randomization is performed after the baseline assessment to avoid influencing participants' expectations or performance during initial testing. Each group completes 12 training sessions over four weeks (three per week). Sessions are structured to include a brief warm-up, movement familiarization at submaximal intensity, and a series of high-intensity isometric contractions. All force measurements during training are collected using a handheld dynamometer, providing objective data on individual progress and allowing researchers to track variations in force output across sessions.

Assessment Procedures Participants undergo comprehensive baseline, post-intervention, and follow-up evaluations. Strength assessments include hip abductors and external rotators measured in distraction using a VALD dynamometer. This measurement technique ensures consistent joint positioning and minimizes compensation. Ankle strength is assessed through handheld dynamometry in four primary movement directions: plantarflexion, dorsiflexion, inversion, and eversion. Because both proximal and distal deficits may influence movement control, these measurements are critical for evaluating whether strength gains differ based on intervention type.

Intrinsic foot muscle endurance is evaluated using the Heel Rise Test, a functional endurance task widely used in lower-limb rehabilitation research. Dynamic postural control is assessed via the modified Star Excursion Balance Test (Y-Balance Test), normalized to limb length to allow inter-participant comparison. Reactive agility and lateral movement control are evaluated using the Side Hop Test. Ankle mobility is assessed through the Weight-Bearing Lunge Test, a reliable measure of dorsiflexion range of motion.

Collectively, these performance tests capture key domains involved in CAI-strength, balance, mobility, and functional endurance-allowing the analysis to examine global changes across motor-behavior deficits.

Intervention Programs The ankle strengthening program consists of four isometric exercises targeting plantarflexion, dorsiflexion, inversion, and eversion. These muscle groups are directly implicated in maintaining ankle joint stability and controlling rear-foot positioning during dynamic activities.

The hip strengthening program includes clamshells at 60° of hip flexion, hip external rotation, hip abduction, and hip extension. These exercises engage the gluteus medius, gluteus maximus, and deep external rotators-muscles essential for controlling femoral positioning and mitigating excessive internal rotation or adduction during single-leg tasks.

The combined program alternates exercises from both regions, ensuring equal exposure to distal and proximal strengthening stimuli. Because CAI encompasses both local impairments and broader kinetic-chain dysfunctions, this hybrid approach may offer a more comprehensive therapeutic stimulus.

Each strengthening session includes three sets of each targeted movement, with six maximal 5-second isometric repetitions per set. The intensity target is 100% MVC, with short recovery periods between contractions. This structure ensures a high neuromuscular demand within a time-efficient session design.

Data Management and Analysis All participant data, including force outputs and functional performance results, are anonymized and stored securely. The dataset is analyzed using mixed factorial ANOVA to examine group effects, time effects, and Group × Time interactions. This statistical model is particularly suited for longitudinal interventional studies, as it evaluates whether improvements over time differ across treatment groups. Post-hoc testing is conducted when significant interactions arise, using Bonferroni adjustments to control for multiple comparisons.

This analytical approach helps determine whether the interventions produce distinct recovery trajectories and clarifies which program is most effective for improving various CAI-related outcomes. Because prior research often relied on unifocal strengthening strategies, this study may highlight the relative importance of targeting hip musculature versus ankle musculature or both.

Ethical Considerations All participants provide informed consent prior to enrollment and are informed of their right to withdraw at any time. Data are handled according to GDPR requirements and stored for 20 years in anonymized form. Only aggregated, non-identifiable results will be published.

Expected Impact The study has the potential to inform best-practice rehabilitation strategies for chronic ankle instability. Should the combined strengthening program demonstrate superior outcomes, it would support integrating proximal strengthening as a standard component of CAI rehabilitation. Conversely, if isolated hip or ankle strengthening proves equally effective, clinicians may adapt treatment plans based on patient tolerance, preference, or resource availability. Beyond clinical implications, the study contributes to the understanding of how neuromuscular training influences the diverse deficits encompassed by the CAI model.

Being tested
Isometric Ankle Strengthening Program, Hip Strengthening, Combined Isometric Ankle and Hip Strengthening Program
Keywords
chronic ankle instability, Ankle strengthening, Hip strengthening, Isometric exercise, Physiotherapy, Rehabilitation, Randomized controlled trial
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isometric Ankle Strengthening ProgramOther

    This intervention consists of an isometric ankle strengthening program targeting plantar flexion, dorsiflexion, inversion, and eversion. Exercises are performed using a handheld dynamometer. Participants complete three supervised sessions per week for four weeks.

  • Hip StrengtheningOther

    This intervention consists of an isometric hip strengthening program targeting hip abductors, external rotators, and extensors. Exercises are performed using a handheld dynamometer. Participants complete three supervised sessions per week for four weeks.

  • Combined Isometric Ankle and Hip Strengthening ProgramOther

    This intervention consists of a combined isometric ankle and hip strengthening program reflecting usual physiotherapy practice. The program includes the same ankle and hip exercises as the single-intervention programs. Exercises are performed using a handheld dynamometer during three supervised sessions per week for four weeks.

Study groups in NCT07606534
Study groupRoleWhat they receive
Ankle StrengtheningExperimentalParticipants in this arm receive an isometric ankle strengthening program targeting plantar flexion, dorsiflexion, inversion, and eversion. The program is performed three times per week for four weeks, under supervision, using a handheld dynamometer.
Receives: Other: Isometric Ankle Strengthening Program
Hip StrengtheningExperimentalParticipants in this arm receive an isometric hip strengthening program targeting hip abductors, external rotators, and extensors. The program is performed three times per week for four weeks, under supervision, using a handheld dynamometer.
Receives: Other: Hip Strengthening
Combined Ankle-Hip StrengtheningActive comparatorParticipants in this arm receive a combined isometric ankle and hip strengthening program reflecting usual physiotherapy practice. The program includes the same ankle and hip exercises as the single-intervention arms and is performed three times per week for four weeks, under supervision, using a handheld dynamometer.
Receives: Other: Combined Isometric Ankle and Hip Strengthening Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumberland Ankle Instability Tool (CAIT)

    The Cumberland Ankle Instability Tool (CAIT) is a validated patient-reported outcome measure assessing perceived ankle instability. Scores range from 0 to 30, with lower scores indicating greater perceived instability. Change in CAIT score over time will be compared between intervention groups.

    Measured: Baseline and week 4 (end of intervention)

Secondary outcomes (7)
  1. Foot and Ankle Ability Measure (FAAM) - Sport Subscale

    Scores 0-100; higher scores indicate better function during sports activities.

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  2. Hip Muscle Strength

    Isometric hip strength (abductors/external rotators/extensors) measured with a handheld dynamometer.

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  3. Ankle Muscle Strength

    Isometric ankle strength (plantar flexion/dorsiflexion/inversion/eversion) measured with a handheld dynamometer.

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  4. Dynamic Postural Balance (Y Balance Test)

    Reach distances normalized to lower limb length.

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  5. Side Hop Test Performance

    Time to complete 10 jump round trips

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  6. Ankle Dorsiflexion Range of Motion (Weight Bearing Lunge Test)

    Distance from hallux to wall during WBLT.

    Measured: Baseline, week 4 (end of intervention), and week 8 (follow-up)

  7. Cumberland Ankle Instability Tool (CAIT) Score at Week 8

    The Cumberland Ankle Instability Tool (CAIT) is a validated patient-reported outcome measure assessing perceived ankle instability. Scores range from 0 to 30, with lower scores indicating greater perceived instability. CAIT score measured at follow-up to assess perceived ankle instability after the intervention period.

    Measured: Week 8 (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start2 Mar 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
Model description
Participants are randomly assigned to one of three parallel intervention groups: ankle strengthening, hip strengthening, or combined ankle-hip strengthening. All interventions are delivered over a 4-week period with three sessions per week.
Masking
Single blind
Who is masked
Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606534
Sponsor's protocol ID
2025-400
Acronym
SHAC
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khalaj N, Vicenzino B, Heales LJ, Smith MD. Is chronic ankle instability associated with impaired muscle strength? Ankle, knee and hip muscle strength in individuals with chronic ankle instability: a systematic review with meta-analysis. Br J Sports Med. 2020 Jul;54(14):839-847. doi: 10.1136/bjsports-2018-100070. Epub 2020 Jan 14.

    PubMed 31937576
  • Wright CJ, Linens SW, Cain MS. A Randomized Controlled Trial Comparing Rehabilitation Efficacy in Chronic Ankle Instability. J Sport Rehabil. 2017 Jul;26(4):238-249. doi: 10.1123/jsr.2015-0189. Epub 2016 Aug 24.

    PubMed 27632874
  • Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.

    PubMed 24377963
  • Hertel J, Corbett RO. An Updated Model of Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):572-588. doi: 10.4085/1062-6050-344-18. Epub 2019 Jun 4.

    PubMed 31162943

Questions about this trial

What is this clinical trial studying?

A study testing Isometric Ankle Strengthening Program, Hip Strengthening and Combined Isometric Ankle and Hip Strengthening Program in people with Chronic Ankle Instability, CAI and Ankle Sprain, run by University of Liege at 1 site in Belgium.

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 6 inclusion and 5 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 26 May 2026. 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 Belgium. 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 Aude Aguilaniu Aude, PhD (+32483421291, aude.aguilaniu@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumberland Ankle Instability Tool (CAIT) (time frame: Baseline and week 4 (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07606534, which also lists 4 linked publications.

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 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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