Lateral Ankle SprainNCT07030634
Blood Flow Restriction and Proprioception Training on Ankle Joint Sensations
A study testing conventional physical therapy, Low load blood flow restriction and proprioception training in people with Lateral Ankle Sprain, run by Cairo University.
Trial summary
Thirty-four participants with grade I and II recurrent ankle sprain, were referred from orthopaedic physician. Their ages ranged from 20 to 30 years old. All participants will be divided randomly into two groups A, B. Seventeen participants per group. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Lateral Ankle Sprain
- What is being tested?
- conventional physical therapy, Low load blood flow restriction and proprioception training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 20 Aug 2025
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be selected from both sexes.
- Participants BMI will be between 18 and 24.9 (Kg/m²).
- Dominant or non-dominant lower limb .
- Grade I, and II recurrent ankle sprain patients .
- Participants self-reported a history of at least one significant lateral ankle sprain (LAS) greater than 12 months prior to testing, and recurring ankle sprains, ankle "giving way," and/or "feelings of instability."
- Participant will have unilateral recurrent ankle sprain
Who cannot join
- A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
- A history of a fracture in either limb of the lower extremity requiring realignment .
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in interruption of desired physical activity .
- Hip joint or, Knee joint replacement .
- Patients possibly at risk of adverse reactions of blood flow restriction are those with poor circulatory system, obesity, diabetes, arterial calcification, sickle cell trait, severe hypertension, or renal compromise
- Any neurological conditions which affect proprioception such as polyneuropathy, multiple sclerosis, and sensory ataxia .
- Vestibular deficits, and vision problems .
- Pregnancy.
About this study
Official title: Effect of Adding Blood Flow Restriction and Proprioception Training to Traditional Rehabilitation on Ankle Joint Sensations
Thirty-four participants with grade I and II recurrent ankle sprain, were referred from orthopaedic physician. Their ages ranged from 20 to 30 years old. All participants will be divided randomly into two groups A, B. Seventeen participants per group. Participant selected from both sexes, with body mass index between 18 and 24.9 Kg/m², with self-reported history of at least one significant lateral ankle sprain (LAS) greater than 12 months prior to testing and recurring ankle sprains, ankle "giving way" and/or "feelings of instability". Participants with previous surgery or fracture and with any adverse effects to blood occlusion will be excluded.
- Conditions
- Lateral Ankle Sprain
- Being tested
- conventional physical therapy, Low load blood flow restriction, proprioception training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
consist of Strengthening exercise: will begin with isometric exercises performed against an immovable object in four directions of ankle movement (dorsiflexion, planter flexion, inversion, and eversion) and will be progressed to dynamic resistive exercises (isotonic exercises) using ankle weights.
and Bracing: The participants will receive instructions from the therapist about using and applying the soft brace. The soft brace will be based on the principles of the functional tape bandage
Low load blood flow restrictionOther
Patients in blood flow restriction training groups will receive low load resistance exercise (20-40 % 1RM) using tourniquet around thigh proximally to knee joint to occlude arterial blood flow by 50-80 %.
proprioception trainingOther
Patients will receive proprioception exercises in duration of 30 minutes per session, frequencies will be 3 times per week, and lengths for 4 weeks (Matthew et al., 2017). Progression of the proprioceptive training should be static to dynamic (such as lateral movements, backward movements, jumping, cutting, twisting, pivoting), slow speeds to faster speeds with balance and control, two legs to one leg, and with visual control to no visual control.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | A (control group) received conventional physical therapy only Receives: Other: conventional physical therapy |
| Group (B) | Experimental | Experimental Group B received conventional physical therapy with Low load blood flow restriction Receives: Other: conventional physical therapy; Other: Low load blood flow restriction |
| Group (C) | Experimental | received conventional physical therapy with proprioception training Receives: Other: conventional physical therapy; Other: proprioception training |
| Group (D) | Experimental | received conventional physical therapy, Low load blood flow restriction and proprioception training. Receives: Other: conventional physical therapy; Other: Low load blood flow restriction; Other: proprioception training |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak torque of ankle muscles
Each participant will be seated on the dynamometer chair in a relaxed position with the hip joint slightly flexed and the knee flexed about 45° so that the fulcrum of the dynamometer will be corresponded to the axis of the participant's ankle joint with the foot resting on the ankle attachment in a neutral position between dorsi flexion and planter flexion; standard toe straps will be used over the foot. Also, two straps will be wrapped around theextremity proximal to the patella and the pelvis to minimize movements of the trunk, hip, and knee during testing, which would interfere with the ankle measurement
Measured: after three times weekly physiotherapy sessions for four consecutive weeks.
limits of stability
Before the start of each testing session, the Biodex will be calibrated according to the manufacturer's manual. The participants will be familiarized with testing procedures through free practical sessions to minimize the learning effects that occur during testing. All measurements will be performed at level eight of stability (the most suitable level), and the test duration will be set at 20 seconds for three successive trials. Each participant will be tested for stability index (SI) and limits of stability (LOS). The limits of stability (LOS) are defined as the area that the subject safely moves without changing the base of support. The stability index (SI) represents the patient's ability to control balance and motor control skills at 50% LOS
Measured: after three times weekly physiotherapy sessions for four consecutive weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fekry ibrahim salman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030634
- Sponsor's protocol ID
- BFR and proprioception
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Blood Flow Restriction and Proprioception Training to Traditional Rehabilitation on Ankle Joint Sensations
- ClinicalTrials.gov ID
- NCT07030634
- Acronym / sponsor ID
- BFR and proprioception
- Conditions
- Lateral Ankle Sprain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 22 Jun 2025 (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.
Thirty-four participants with grade I and II recurrent ankle sprain, were referred from orthopaedic physician. Their ages ranged from 20 to 30 years old. All participants will be divided randomly into two groups A, B. Seventeen participants per group. Participant selected from both sexes, with body mass index between 18 and 24.9 Kg/m², with self-reported history of at least one significant lateral ankle sprain (LAS) greater than 12 months prior to testing and recurring ankle sprains, ankle "giving way" and/or "feelings of instability". Participants with previous surgery or fracture and with any adverse effects to blood occlusion will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Other: conventional physical therapyA (control group) received conventional physical therapy only |
| Group (B) | Experimental | Other: conventional physical therapy, Other: Low load blood flow restrictionExperimental Group B received conventional physical therapy with Low load blood flow restriction |
| Group (C) | Experimental | Other: conventional physical therapy, Other: proprioception trainingreceived conventional physical therapy with proprioception training |
| Group (D) | Experimental | Other: conventional physical therapy, Other: Low load blood flow restriction, Other: proprioception trainingreceived conventional physical therapy, Low load blood flow restriction and proprioception training. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants will be selected from both sexes.
- Participants BMI will be between 18 and 24.9 (Kg/m²).
- Dominant or non-dominant lower limb .
- Grade I, and II recurrent ankle sprain patients .
- Participants self-reported a history of at least one significant lateral ankle sprain (LAS) greater than 12 months prior to testing, and recurring ankle sprains, ankle "giving way," and/or "feelings of instability."
Key exclusion criteria (8 listed)
- A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
- A history of a fracture in either limb of the lower extremity requiring realignment .
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in interruption of desired physical activity .
- Hip joint or, Knee joint replacement .
- Patients possibly at risk of adverse reactions of blood flow restriction are those with poor circulatory system, obesity, diabetes, arterial calcification, sickle cell trait, severe hypertension, or renal compromise
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 |
|---|---|---|
| conventional physical therapyconsist of Strengthening exercise: will begin with isometric exercises performed against an immovable object in four directions of ankle movement (dorsiflexion, planter flexion, inversion, and eversion) and will be progressed to dynamic resistive exercises (isotonic exercises) using ankle weights. and Bracing: The participants will receive instructions from the therapist about using and applying the soft brace. The soft brace will be based on the principles of the functional tape bandage | Other | Group (A), Group (B), Group (C), Group (D) |
| Low load blood flow restrictionPatients in blood flow restriction training groups will receive low load resistance exercise (20-40 % 1RM) using tourniquet around thigh proximally to knee joint to occlude arterial blood flow by 50-80 %. | Other | Group (B), Group (D) |
| proprioception trainingPatients will receive proprioception exercises in duration of 30 minutes per session, frequencies will be 3 times per week, and lengths for 4 weeks (Matthew et al., 2017). Progression of the proprioceptive training should be static to dynamic (such as lateral movements, backward movements, jumping, cutting, twisting, pivoting), slow speeds to faster speeds with balance and control, two legs to one leg, and with visual control to no visual control. | Other | Group (C), Group (D) |
Primary outcome
peak torque of ankle muscles
Time frame: after three times weekly physiotherapy sessions for four consecutive weeks.
Each participant will be seated on the dynamometer chair in a relaxed position with the hip joint slightly flexed and the knee flexed about 45° so that the fulcrum of the dynamometer will be corresponded to the axis of the participant's ankle joint with the foot resting on the ankle attachment in a neutral position between dorsi flexion and planter flexion; standard toe straps will be used over the foot. Also, two straps will be wrapped around theextremity proximal to the patella and the pelvis to minimize movements of the trunk, hip, and knee during testing, which would interfere with the ankle measurement
limits of stability
Time frame: after three times weekly physiotherapy sessions for four consecutive weeks.
Before the start of each testing session, the Biodex will be calibrated according to the manufacturer's manual. The participants will be familiarized with testing procedures through free practical sessions to minimize the learning effects that occur during testing. All measurements will be performed at level eight of stability (the most suitable level), and the test duration will be set at 20 seconds for three successive trials. Each participant will be tested for stability index (SI) and limits of stability (LOS). The limits of stability (LOS) are defined as the area that the subject safely moves without changing the base of support. The stability index (SI) represents the patient's ability to control balance and motor control skills at 50% LOS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lateral Ankle Sprain
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Not yet recruiting
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
Ankle Sprains, Lateral Ankle Sprain
Recruiting
Mulligan Mobilization With Movement for Acute Lateral Ankle Sprains
Lateral Ankle Sprain
Recruiting
Dynamic Neuromuscular Stability Exercises With and Without Rhythmic Auditory Stimulation in Lateral Ankle Sprain
Ankle Sprain, Lateral Ankle Sprain
RecruitingObservational study
Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
Ankle Sprain, Hypermobility, Joint
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy, Low load blood flow restriction and proprioception training in people with Lateral Ankle Sprain, run by Cairo University.
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 8 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: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak torque of ankle muscles (time frame: after three times weekly physiotherapy sessions for four consecutive weeks.). 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 22 Jun 2025.