Exploring how leg strength training may improve ankle strength and balance in people with chronic ankle instability
| ISRCTN | ISRCTN29754073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29754073 |
| Sponsor | Shenzhen University |
| Funder | Investigator initiated and funded |
- Submission date
- 13/11/2025
- Registration date
- 14/11/2025
- Last edited
- 14/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Ankle sprain is one of the most common musculoskeletal injuries during physical activities, accounting for 16–40% of all sports-related injuries. Many studies have examined the effectiveness of strength training in managing chronic ankle instability (CAI). This pilot study aimed to investigate the effects of a 3-week lower limb strength training program in individuals with CAI.
Who can participate?
Adults aged 18–45 years with chronic ankle instability
What does the study involve?
Participants received 3 weeks of lower limb strength training. The severity of ankle instability, ankle strength and balance ability were evaluated at baseline and after the 3-week intervention. Participants received free and comprehensive exercise-based rehabilitation guidance for ankle instability.
What are the possible benefits and risks of participating?
Participants may benefit from improved ankle strength, balance, and stability. Risks are minimal and may include mild temporary muscle soreness following exercise.
Where is the study run from?
Shenzhen University (China)
When is the study starting and how long is it expected to run for?
The intervention and data collection took place between June and August 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Ziyan Chen, 1900371004@email.szu.edu.cn
Contact information
Principal investigator
School of Physical Education, Shenzhen University
Shenzhen
518060
China
 ORCID ID |
0000-0003-1406-8068 |
|---|---|
| Phone | +86 (0)15992972643 |
| 1900371004@email.szu.edu.cn |
Public, Scientific
School of Physical Education, Shenzhen University
Shenzhen
518060
China
| Phone | +86 (0)13713700760 |
|---|---|
| wang_xd@szu.edu.cn |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Prevention | |
| Scientific title | The effectiveness of lower limb strength training for individuals with ankle instability: a pilot study | |
| Study acronym | CAIST (Chronic Ankle Instability Strength Training) | |
| Study objectives | Based on the concept that the lower extremity functions as an integrated kinetic chain, this pilot study investigated the effects of a 3-week lower limb strength training program in individuals with chronic ankle instability, aiming to evaluate its feasibility and potential benefits on ankle strength, balance, and self-reported stability. | |
| Ethics approval(s) |
Approved 20/06/2022, Medical Ethics Committee, Department of Medicine, Shenzhen University (Department of Medicine, Shenzhen University, Shenzhen, 518060, China; +86 (0)755-86671906; spchen@szu.edu.cn), ref: PN-202200034 | |
| Health condition(s) or problem(s) studied | Chronic ankle instability (CAI) | |
| Intervention | Participants in this study received a 3-week lower limb strength training program. Throughout the 3-week intervention, participants were provided with guidance and supervision by an experienced sports therapist during 45-minute sessions, held three times per week in the laboratory at Shenzhen University. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 20/08/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 8 |
| Key inclusion criteria | 1. Aged between 18 and 45 years (to avoid confounding factors related to older age) 2. Participants who had chronic ankle instability (CAI), defined as having experienced a significant ankle sprain and/or recurrent ankle sprain on the same ankle, and/or feel ankle instability, and/or experiencing giving way at least twice in the past 6 months 3. Normal cognitive function, with no history of craniocerebral injury, cerebrovascular disease, epilepsy, or other complications 4. Able to participate in moderate physical activity 5. No participation in any CAI-related exercise rehabilitation programs within the three months prior to the study 6. Provided written informed consent prior to participation 7. The affected ankle was not in the acute phase of injury |
| Key exclusion criteria | 1. Acute ankle sprain or other lower limb injuries within the last 3 months 2. History of ankle surgery, fracture, or significant joint deformity 3. Neurological or vestibular disorders affecting balance or movement 4. Inability to perform exercise safely or follow instructions 5. Current participation in other rehabilitation or strength training programs |
| Date of first enrolment | 20/06/2022 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Shenzhen
518060
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
14/11/2025: Study's existence confirmed by the Medical Ethics Committee, Department of Medicine, Shenzhen University.
