The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Hip Replacement
- Sponsor
- University of Pavia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Weight Bearing Absolute difference between lower limbs (ΔWBA)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Luca Marin
Principal Investigator
University of Pavia
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Weight Bearing Absolute difference between lower limbs (ΔWBA)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: between the 4th and the 10th day post surgery
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Secondary Outcomes
- 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)