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临床试验/NCT07030634
NCT07030634尚未招募不适用

Effect of Adding Blood Flow Restriction and Proprioception Training to Traditional Rehabilitation on Ankle Joint Sensations

Cairo University0 个研究点目标入组 60 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
peak torque of ankle muscles

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

peak torque of ankle muscles

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed fekry ibrahim salman

assistant professor

Cairo University

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