Ankle SprainNCT06962943
Auto-regulated Blood Flow Restriction in Athletes With Recurrent Ankle Sprain
A study testing Auto-regulated Blood Flow Restriction Training and Non-regulated Blood Flow Restriction Training in people with Ankle Sprain and Ankle Instability, run by Prince Sattam Bin Abdulaziz University at 1 site in United Arab Emirates.
Trial summary
Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprain, Ankle Instability
- What is being tested?
- Auto-regulated Blood Flow Restriction Training and Non-regulated Blood Flow Restriction Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Nov 2023to 2 Feb 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranges from 18 to 40 years.
- No other health related conditions such as diabetes or hypertension.
- Unilateral or bilateral CIA.
- Male Athletes.
Who cannot join
- Knee or hip injury within the last 3 months.
- Previous ankle surgery.
- Any contraindication for BFRT application such as venous insufficiency, arterial insufficiency, history of DVT.
- Spinal lesion affecting lower limb function.
- Females
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Walid Kamal Abdelbasset
Sharjah city, Emirate of Sharjah, 27272
About this study
Official title: The Additional Effect of Auto-Regulated Blood Flow Restriction Exercise on Functional Performance and Muscle Fatigability in Athletes With Recurrent Ankle Sprain: A Randomized Controlled Clinical Study
Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.
Read the detailed description
Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training.
This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.
At the Sharjah University Medical Campus, 45 athletes from Shabab Al Ahli Club, aged 18-40, participated in this randomized control study. The investigators randomly allocated the participants into three equal groups, with 15 individuals in each group. The investigators recruited the first group to an auto-regulated blood flow restriction training plus traditional treatment program (ARBFRT+TT), the second group to a non-regulated blood flow restriction training plus traditional treatment program (NRBFRT+TT), and the third group to a traditional treatment program only without BFRT (TT group). The investigators assessed extrinsic foot muscle strength using an isokinetic device and functional performance using Functional Ankle Disability Index (FADI) and Rate of perceived exertion scale (RPES), both pre- and post 6-week treatment.
- Conditions
- Ankle Sprain, Ankle Instability
- Being tested
- Auto-regulated Blood Flow Restriction Training, Non-regulated Blood Flow Restriction Training, Control group
- Keywords
- Ankle instability, Blood flow restriction, Fatigability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-regulated Blood Flow Restriction TrainingOther
This group was recruited to conduct auto-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used to automatically determine the individualized 50% arterial blood occlusion pressure for the BFRT group at the femoral artery, the cuff was connected to the smart tool device for the auto-regulated group to regulate the cuff pressure during muscle contraction and relaxation. The cuff was deflated in between exercises.
Non-regulated Blood Flow Restriction TrainingOther
This group was recruited to conduct a non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device in the non-regulated blood flow restriction training group and the pressure was stabilized as the initial pressure determined by the device in the non-regulated group. The cuff was deflated in between exercises.
Control groupOther
This group was recruited to conduct no blood flow restriction exercise 30 min, three times a week for 6 weeks. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device and the pressure was 0 (zero) in this group. The cuff was deflated in between exercises.
| Study group | Role | What they receive |
|---|---|---|
| Auto-regulated blood flow restriction training (ARBFRT+TT) | Experimental | This group was recruited to conduct auto-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist. Receives: Other: Auto-regulated Blood Flow Restriction Training |
| Non-regulated blood flow restriction training (NRBFRT+TT) | Active comparator | This group was recruited to conduct non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist. Receives: Other: Non-regulated Blood Flow Restriction Training |
| Control group | Placebo comparator | The control group was recruited to conduct no blood flow restriction exercise (Cuff with 0 pressure) 30-min, three times a week for 6 weeks. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
An isokinetic dynamometer (Physiomed Elektromedizin AG [TP Module, CON-TREX MJ], Schnaittach, Germany) was used for strength testing. Using the previously identified ankle evertors/invertors and plantarflexors/dorsiflexors muscles, the investigators assessed the average peak torque to body weight ratio (concentric/concentric) at an angular velocity of 60°/s. Calibration of the dynamometer was performed prior to evaluation. Submaximal three and maximal three exercise sessions were given to participants to acclimate them to the testing methodology. Each subject rested for two minutes before cycling through the active range of motion three times in a row at maximum concentric contraction. To provide sufficient recovery between contractions, a 5-minute rest interval was included in each test condition. It was expected that participants would give it their all when taking the exam. For every test, the appropriate ankle isokinetic device was used for strength testing.
Measured: 6 weeks
Secondary outcomes (2)
Foot and ankle disability index
For the purpose of clinical treatment and research investigations involving young people with chronic ankle instability, the foot and ankle disability index (FADI) self-report measure was advocated. Results showed that it was responsive, reliable, and valid for patients with chronic ankle instability. There are a total of 26 items: 22 that pertain to activities and 4 that are associated with pain. The activity item is assessed on a scale from 0 (very difficult) to 4 (very easy), whereas the FADI 4 pain items are graded from 0 (very terrible pain) to 4 (very little pain) (Hale and Hertel, 2005). The overall value of the FADI is 104 points. A score of 100% on the FADI indicated that there was no abnormality.
Measured: 6 weeks
Fatigability level
The Rating of Perceived Exertion scale (RPES) was used to assess the level of fatigability, which ranges from 0 to 10, was used to describe the amount of exhaustion experienced by the participants just before to their injuries. A score of 0 indicates that there was no effort at all, while a score of 10 indicates that the exertion was exceedingly intense. The quantity of typical physical activity, measured in hours per week, that was performed, was recorded in order to ascertain the degree of physical fitness achieved
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Nov 2023
- Primary completion30 Jan 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sharjah
- Responsible party
- Principal investigator, Walid Kamal Abdelbasset, PhD, Prince Sattam Bin Abdulaziz University
- Investigators
- Abdelbasset, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962943
- Sponsor's protocol ID
- REC-23-08-28-02-PG
- Other IDs
- University of Sharjah
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Effect of Auto-Regulated Blood Flow Restriction Exercise on Functional Performance and Muscle Fatigability in Athletes With Recurrent Ankle Sprain: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06962943
- Acronym / sponsor ID
- REC-23-08-28-02-PG
- Conditions
- Ankle Sprain, Ankle Instability
- Keywords
- Ankle instability, Blood flow restriction, Fatigability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Collaborators
- University of Sharjah
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 8 May 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.
Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.
Detailed description
Ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. Blood Flow Restriction Training (BFRT) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training.
This Randomized Controlled study explores the application of BFRT in addressing Chronic Ankle Instability (CAI), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.
At the Sharjah University Medical Campus, 45 athletes from Shabab Al Ahli Club, aged 18-40, participated in this randomized control study. The investigators randomly allocated the participants into three equal groups, with 15 individuals in each group. The investigators recruited the first group to an auto-regulated blood flow restriction training plus traditional treatment program (ARBFRT+TT), the second group to a non-regulated blood flow restriction training plus traditional treatment program (NRBFRT+TT), and the third group to a traditional treatment program only without BFRT (TT group). The investigators assessed extrinsic foot muscle strength using an isokinetic device and functional performance using Functional Ankle Disability Index (FADI) and Rate of perceived exertion scale (RPES), both pre- and post 6-week treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auto-regulated blood flow restriction training (ARBFRT+TT) | Experimental | Other: Auto-regulated Blood Flow Restriction TrainingThis group was recruited to conduct auto-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist. |
| Non-regulated blood flow restriction training (NRBFRT+TT) | Active comparator | Other: Non-regulated Blood Flow Restriction TrainingThis group was recruited to conduct non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist. |
| Control group | Placebo comparator | Other: Control groupThe control group was recruited to conduct no blood flow restriction exercise (Cuff with 0 pressure) 30-min, three times a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranges from 18 to 40 years.
- No other health related conditions such as diabetes or hypertension.
- Unilateral or bilateral CIA.
- Male Athletes.
Key exclusion criteria (5 listed)
- Knee or hip injury within the last 3 months.
- Previous ankle surgery.
- Any contraindication for BFRT application such as venous insufficiency, arterial insufficiency, history of DVT.
- Spinal lesion affecting lower limb function.
- Females
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 |
|---|---|---|
| Auto-regulated Blood Flow Restriction TrainingThis group was recruited to conduct auto-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used to automatically determine the individualized 50% arterial blood occlusion pressure for the BFRT group at the femoral artery, the cuff was connected to the smart tool device for the auto-regulated group to regulate the cuff pressure during muscle contraction and relaxation. The cuff was deflated in between exercises. | Other | Auto-regulated blood flow restriction training (ARBFRT+TT) |
| Non-regulated Blood Flow Restriction TrainingThis group was recruited to conduct a non-regulated blood flow restriction exercise for 30-min, three times a week for six weeks by a trained physiotherapist, the subjects were asked to perform the following exercises: standing single leg calf raises with lateral resistance using a band, seated soleus raise, single leg balance on the edge of a step clearing the front foot with band on the big toe. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device in the non-regulated blood flow restriction training group and the pressure was stabilized as the initial pressure determined by the device in the non-regulated group. The cuff was deflated in between exercises. | Other | Non-regulated blood flow restriction training (NRBFRT+TT) |
| Control groupThis group was recruited to conduct no blood flow restriction exercise 30 min, three times a week for 6 weeks. SmartCuff 3.0 BFRT tool was used, whilst the cuff was not connected to the device and the pressure was 0 (zero) in this group. The cuff was deflated in between exercises. | Other | Control group |
Primary outcome
Muscle Strength
Time frame: 6 weeks
An isokinetic dynamometer (Physiomed Elektromedizin AG [TP Module, CON-TREX MJ], Schnaittach, Germany) was used for strength testing. Using the previously identified ankle evertors/invertors and plantarflexors/dorsiflexors muscles, the investigators assessed the average peak torque to body weight ratio (concentric/concentric) at an angular velocity of 60°/s. Calibration of the dynamometer was performed prior to evaluation. Submaximal three and maximal three exercise sessions were given to participants to acclimate them to the testing methodology. Each subject rested for two minutes before cycling through the active range of motion three times in a row at maximum concentric contraction. To provide sufficient recovery between contractions, a 5-minute rest interval was included in each test condition. It was expected that participants would give it their all when taking the exam. For every test, the appropriate ankle isokinetic device was used for strength testing.
2 secondary outcomes
Foot and ankle disability index
Time frame: 6 weeks
Fatigability level
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
Abdelbasset principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-regulated Blood Flow Restriction Training and Non-regulated Blood Flow Restriction Training in people with Ankle Sprain and Ankle Instability, run by Prince Sattam Bin Abdulaziz University at 1 site in United Arab Emirates.
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 4 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: finished, as of the sponsor's last update on 14 May 2025. 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 United Arab Emirates. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Strength (time frame: 6 weeks). 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 14 May 2025.