UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059860 |
|---|---|
| Receipt number | R000068450 |
| Scientific Title | Effects of Six Weeks of Balance Training With or Without Proximal-Shank Blood Flow Restriction on Pain, Ankle Muscle Strength, Perceived Instability, Dynamic Balance, Proprioception, and Functional Performance in Athletes With Chronic Ankle Instability: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/11/22 16:26:34 |
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Basic information
Public title
Effect of 6 Weeks of Balance Training With or Without Blood Flow Restriction on Pain, Muscle Strength, and Functional Performance in Athletes With Chronic Ankle Instability
Acronym
BFR-BT-CAI
Scientific Title
Effects of Six Weeks of Balance Training With or Without Proximal-Shank Blood Flow Restriction on Pain, Ankle Muscle Strength, Perceived Instability, Dynamic Balance, Proprioception, and Functional Performance in Athletes With Chronic Ankle Instability: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Six Weeks of Balance Training With or Without Proximal-Shank Blood Flow Restriction on Pain, Ankle Muscle Strength, Perceived Instability, Dynamic Balance, Proprioception, and Functional Performance in Athletes With Chronic Ankle Instability: A Randomized Controlled Trial (BFR-BT-CAI)
Region
| Asia(except Japan) |
Condition
Condition
Functional Ankle Instability
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether adding proximal-shabk blood flow restriction (BFR) to a 6-week progressive balance training program results in greater reductions in pain and perceived ankle instability, as well as larger improvements in dynamic postural control, compared to the same balance training program performed without BFR in athletes with chronic ankle instability (CAI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine whether adding proximal-shabk blood flow restriction (BFR) to a 6-week progressive balance training program results in greater reductions in pain and perceived ankle instability, as well as larger improvements in dynamic postural control, compared to the same balance training program performed without BFR in athletes with chronic ankle instability (CAI).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
6 weeks, 3 sessions/week, 30-45 min per session. Identical progressive unilateral balance exercises (single-leg stance, squats, hops, tuck jumps, ball tasks, unstable surfaces, eyes closed progressions) performed on the involved limb with a 10-cm wide pneumatic cuff applied to the proximal shank at 70-80% limb occlusion pressure (LOP). Cuff inflated continuously during the exercise block (15-20 min) and deflated during warm-up and cool-down.
Interventions/Control_2
Exactly the same 6-week, 3 sessions/week progressive unilateral balance training program as the experimental group (identical exercises, volume, intensity, and progression), but performed without any cuff application.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Male recreational or competitive athlete
At least two episodes of giving way at the ankle in the past 6 months
Unilateral chronic functional ankle instability
Key exclusion criteria
Key Exclusion Criteria
Bilateral chronic ankle instability
Mechanical ankle instability (positive anterior drawer or talar tilt test >1+ on clinical examination)
Acute ankle sprain or lower-extremity injury within the previous 3 months
History of fracture or surgery in the lower extremity
Neurological, vestibular, or severe visual impairment that affects balance
Diagnosed deep vein thrombosis, peripheral vascular disease, or any absolute contraindication to blood flow restriction
Hypertension (resting blood pressure >140/90 mmHg)
Current participation in a formal ankle rehabilitation or strength-training program
Inability or unwillingness to adhere to the 6-week supervised training protocol (3 sessions/week)
Any medical condition that, in the opinion of the investigator, would make BFR or intensive balance training unsafe
Female sex (study limited to male participants only)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport Scince
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport science
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
Homepage URL
ay.naderi@shahodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Physical Education
Address
Shahrood University of Technology
Tel
087 3366 4600
ay.naderi@shahroodut.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068450
