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临床试验/NCT05090423
NCT05090423已完成不适用

The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Ankle range of motion

研究概览

简要总结

Approximately 40% of acute ankle sprain would develop into chronic ankle instability (CAI). Chronic ankle instability is characterized by pain, repeated sprains and giving way. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Also, the other study indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear.

Therefore, the aim of the study is to investigate the effect of additional neurodynamic intervention on the ankle range of motion, mechanosensitivity, balance performance and self-reported function.

详细描述

Chronic ankle instability (CAI) is characterized by pain, repeated sprains and giving way. Approximately 40% of acute ankle sprain would develop into chronic ankle instability. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Pahor et al., indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear. Purpose: The aim of the study is to investigate the effects of neurodynamic intervention on the mechanosensitivity, balance performance and self-reported function in patients with CAI. Study design: A randomized controlled trial design. Single-blinded. Methods: Forty subjects between 20-50 with CAI were recruited and randomized into either the exercise only group or the neurodynamic intervention with exercise (neurodynamic) group. The sample size was calculated based on the PPT data of Lorenzo-Sanchez-Aguilera et al's, which requires 20 subjects in each group to reach a statistical power of 0.8. Both groups were receive 12 interventions within 6-8 weeks. The exercise only group performed balance training, while the neurodynamic group received balance training and neurodynamic intervention for the common peroneal nerve. Outcome measures included demographic data, pressure pain threshold, active knee extension range of motion (ROM) of the slump test with ankle plantarflexion and inversion (AKEOST), hamstrings flexibility, ankle range of motion, Y balance test and foot and ankle ability measure (FAAM).

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of at least two ankle sprains in the same leg, of which the first sprain is more than one year
  • Leading to at least one interrupted day of desired physical activity
  • The Cumberland Ankle Instability Tool (CAIT) ≦ 24
  • Slump test in ankle plantar flexion with inversion: positive

排除标准

  • Surgical treatments
  • Previous fractures in either lower extremity
  • Any concomitant lower extremity pathology, for example, vascular disease, osteoarthritis and rheumatoid arthritis
  • Significant pain or injury to the lumbar or cervical spine
  • Regular use of medication: anti-inflammatory drugs, painkiller, steroid or muscle relaxants
  • Previous manual therapy or exercise interventions received on the lower extremity within the previous 3 months

结局指标

主要结局

Ankle range of motion

时间窗: post 6 weeks intervention

Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.

Mechanosensitivity: Pain pressure threshold

时间窗: post 6 weeks intervention

Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.

Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion

时间窗: post 6 weeks intervention

The subjects sit on the edge of the bed without touching ground with their feet. The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.

Balance performance

时间窗: post 6 weeks intervention

The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.

Self-reported function: The Foot and Ankle Ability Measures (FAAM)

时间窗: post 6 weeks intervention

The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability

Pressure Pain Threshold- Anterior Talofibular Ligament

时间窗: Within one week after 12 treatment sessions

Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the anterior talofibular ligament. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

Pressure Pain Threshold- Calcaneofibular Ligament

时间窗: Within one week after 12 treatment sessions

Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the calcaneofibular ligament. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion

时间窗: Within one week after 12 treatment session

The subjects sat on the edge of the bed without touching the ground with their feet. The physical therapist assisted the subjects in maintaining a neutral pelvis position. First, the subjects were asked to flex the neck, trunk, and finally the lumbar to tighten the back. Second, while the subjects plantarflexed and inverted the ankle, they performed the knee extension movement, and the angle of knee motion was recorded. Participants performed three practice trials followed by three test trials and averaged the three tests.

Pressure Pain Threshold- Peroneal Brevis Muscle

时间窗: Within one week after 12 treatment sessions

Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the peroneal brevis muscle. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

Pressure Pain Threshold- Peroneal Longus Muscle

时间窗: Within one week after 12 treatment sessions

Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the peroneal longus muscle. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

Pressure Pain Threshold- Common Peroneal Nerve

时间窗: Within one week after 12 treatment sessions

Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the common peroneal nerve. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

次要结局

  • Y Balance Test- Anterior Direction(Within one week after 12 treatment sessions)
  • The Foot and Ankle Ability Measures- Sports(Within one week after 12 treatment sessions)
  • The Foot and Ankle Ability Measures- Activity of Life(Within one week after 12 treatment sessions)
  • Weight Bearing Lunge Test(Within one week after 12 treatment sessions)
  • Hamstring Flexibility(Within one week after 12 treatment sessions)
  • The Foot and Ankle Ability Measures- Activity of Life (Self- Awareness Score)(Within one week after 12 treatment sessions)
  • The Foot and Ankle Ability Measures- Sports (Self- Awareness Score)(Within one week after 12 treatment sessions)
  • Y Balance- Posterolateral Direction(Within one week after 12 treatment sessions)
  • Y Balance- Posteromedial Direction(Within one week after 12 treatment sessions)

研究者

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

Yi-Fen Shih

Professor

National Yang Ming Chiao Tung University

研究点 (1)

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