The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight Bearing Absolute difference between lower limbs (ΔWBA)
研究概览
简要总结
The study investigates the effects of visual biofeedback, based on a sensorized system for the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal instructions of the physiotherapist, on weight bearing distribution in patients who underwent first total hip replacement. The study is a randomized controlled trial, with parallel groups, without blinding.
详细描述
Forty patients, who underwent first total hip replacement surgery were enrolled and divided into two groups on second postoperative day. Experimental group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images on three monitors. Control Group followed verbal instructions of physiotherapist during training. From 4th to 10th postoperative day both groups followed the same rehabilitation program including exercises to restore correct weight bearing.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •75 ≤ years of age,
- •absence of conditions that could alter the gait cycle,
- •absence of conditions that could reduce or alter visual ability,
- •etherometry ≤ 0.5 mm
- •Mini-Mental State Examination (MMSE) score ≥ 24.
排除标准
- 未提供
研究组 & 干预措施
Experimental Group
The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors.
干预措施: Visual biofeedback with the use of sensorized insoles (Device)
Control Group
The Control Group followed verbal instructions of physiotherapist during training.
干预措施: Standard rehabilitation based on physiotherapist's verbal instructions (Other)
结局指标
主要结局
Weight Bearing Absolute difference between lower limbs (ΔWBA)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Weight Bearing Absolute Surgical limb (WBAS)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform
Weight Bearing Percentage Healthy limb (WBPH)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Weight Bearing Absolute Healthy limb (WBAH)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Weight Bearing Percentage difference between lower limbs (ΔWBP)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Weight Bearing Percentage Surgical limb (WBPS)
时间窗: between the 4th and the 10th day post surgery
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
次要结局
- Mid Step Length Healthy limb (MSLH)(between the 4th and the 10th day post surgery)
- Sway Healthy limb (SWH)(between the 4th and the 10th day post surgery)
- Double Support Time (DST)(between the 4th and the 10th day post surgery)
- Six Minutes Walking Test (6MWT)(between the 4th and the 10th day post surgery)
- World Health Organization Quality of Life Questionnaire (WHOQOL)(between the 4th and the 10th day post surgery)
- Mid Step Length Surgical limb (MSLS)(between the 4th and the 10th day post surgery)
- Sway Surgical limb (SWS)(between the 4th and the 10th day post surgery)
- Numeric Rating Scale (NRS)(between the 4th and the 10th day post surgery)
研究者
Luca Marin
Principal Investigator
University of Pavia