Blood Flow Restriction and Proprioception Training on Ankle Joint Sensations

NCT ID: NCT07030634

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-08-20

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group (A)

A (control group) received conventional physical therapy only

Group Type: ACTIVE_COMPARATOR

conventional physical therapy

Intervention Type: OTHER

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

Group (B)

Experimental Group B received conventional physical therapy with Low load blood flow restriction

Group Type: EXPERIMENTAL

conventional physical therapy

Intervention Type: OTHER

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 restriction

Intervention Type: OTHER

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 %.

Group (C)

received conventional physical therapy with proprioception training

Group Type: EXPERIMENTAL

conventional physical therapy

Intervention Type: OTHER

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

proprioception training

Intervention Type: OTHER

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.

Group (D)

received conventional physical therapy, Low load blood flow restriction and proprioception training.

Group Type: EXPERIMENTAL

conventional physical therapy

Intervention Type: OTHER

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 restriction

Intervention Type: OTHER

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 training

Intervention Type: OTHER

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.

Interventions

conventional physical therapy

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

Intervention Type: OTHER

Low load blood flow restriction

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 %.

Intervention Type: OTHER

proprioception training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed fekry ibrahim salman

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BFR and proprioception

Identifier Type: -

Identifier Source: org_study_id