Ankle SprainsNCT05920044
Balance and Proprioception Training Program in Patients With Chronic Ankle Sprains
A study testing balance and proprioception training program. in people with Ankle Sprains, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
To examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- balance and proprioception training program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jun 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18-55 years
- History of at least two ankle sprains within the last 12 months
- Presence of ankle instability symptoms, such as recurrent giving way or chronic pain
Who cannot join
- Acute ankle injury within the last six weeks
- Lower extremity fracture within the last six months
- Other musculoskeletal or neurological disorders affecting the lower extremity
- Inability to comply with study requirements
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: The Effects of an Individualized Balance and Proprioception Training Program on Pain and Function in Patients With Chronic Ankle Sprains: A Randomized Controlled Trial
To examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains.
- Conditions
- Ankle Sprains
- Being tested
- balance and proprioception training program., Usual care
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance and proprioception training program.Other
The program will include exercises focused on improving ankle stability and joint position sense, such as single-leg stance, wobble board, and resistance band exercises.
Participants will attend two supervised sessions per week and perform home-based exercises 3-4 times per week.
Progression of exercises will be individualized based on participant performance and tolerance.
Usual careOther
Participants will continue their usual care, including general strength and flexibility exercises.
No specific balance and proprioception training will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: | Experimental | Participants will receive an eight-week individualized balance and proprioception training program. Receives: Other: balance and proprioception training program. |
| Control group | Active comparator | Participants will continue their usual care, including general strength and flexibility exercises. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain intensity
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS)
Measured: Changes in Pain intensity at baseline, 8 weeks, and 16 weeks follow up
Changes in Functional Ability
Functional ability will be assessed using the Foot and Ankle Ability Measure (FAAM)
Measured: Changes in Functional ability at baseline, 8 weeks, and 16 weeks follow up
Secondary outcomes (3)
Changes in Balance
Balance will be assessed using the Star Excursion Balance Test (SEBT)
Measured: Changes in balance at baseline, 8 weeks, and 16 weeks follow up
Changes in Proprioception
Proprioception will be measured using the joint position sense test with an ankle electrogoniometer
Measured: Changes in proprioception at baseline, 8 weeks, and 16 weeks follow up
Incidence of Recurrent Ankle Sprains
Incidence of recurrent ankle sprains during the follow-up period will be recorded
Measured: From post-intervention at 8 weeks to the end of the follow-up period at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start27 Jun 2023 (estimated)
- Primary completion27 Jun 2024 (estimated)
- Study completion12 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920044
- Sponsor's protocol ID
- 012/Ank-01200021
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Individualized Balance and Proprioception Training Program on Pain and Function in Patients With Chronic Ankle Sprains: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05920044
- Acronym / sponsor ID
- 012/Ank-01200021
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 27 Jun 2023 (estimated)
- Primary completion
- 27 Jun 2024 (estimated)
- Study completion
- 12 Jul 2024 (estimated)
- First posted
- 27 Jun 2023 (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.
To examine the effects of an individualized balance and proprioception training program on pain, function, and the risk of recurrent ankle sprains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: | Experimental | Other: balance and proprioception training program.Participants will receive an eight-week individualized balance and proprioception training program. |
| Control group | Active comparator | Other: Usual careParticipants will continue their usual care, including general strength and flexibility exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-55 years
- History of at least two ankle sprains within the last 12 months
- Presence of ankle instability symptoms, such as recurrent giving way or chronic pain
Key exclusion criteria (4 listed)
- Acute ankle injury within the last six weeks
- Lower extremity fracture within the last six months
- Other musculoskeletal or neurological disorders affecting the lower extremity
- Inability to comply with study requirements
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 |
|---|---|---|
| balance and proprioception training program.The program will include exercises focused on improving ankle stability and joint position sense, such as single-leg stance, wobble board, and resistance band exercises. Participants will attend two supervised sessions per week and perform home-based exercises 3-4 times per week. Progression of exercises will be individualized based on participant performance and tolerance. | Other | Intervention Group: |
| Usual careParticipants will continue their usual care, including general strength and flexibility exercises. No specific balance and proprioception training will be provided. | Other | Control group |
Primary outcome
Changes in Pain intensity
Time frame: Changes in Pain intensity at baseline, 8 weeks, and 16 weeks follow up
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS)
Changes in Functional Ability
Time frame: Changes in Functional ability at baseline, 8 weeks, and 16 weeks follow up
Functional ability will be assessed using the Foot and Ankle Ability Measure (FAAM)
3 secondary outcomes
Changes in Balance
Time frame: Changes in balance at baseline, 8 weeks, and 16 weeks follow up
Changes in Proprioception
Time frame: Changes in proprioception at baseline, 8 weeks, and 16 weeks follow up
Incidence of Recurrent Ankle Sprains
Time frame: From post-intervention at 8 weeks to the end of the follow-up period at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance and proprioception training program. in people with Ankle Sprains, run by Ahram Canadian University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain intensity (time frame: Changes in Pain intensity at baseline, 8 weeks, and 16 weeks follow up). The study lists 2 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 27 Jun 2023.