Insole-based Visual Biofeedback for Weight-bearing in Total Hip Replacement

• Sponsor: University of Pavia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04268082
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Replacement; Visual Biofeedback; Weight Bearing	Device: Visual biofeedback with the use of sensorized insoles; Other: Standard rehabilitation based on physiotherapist's verbal instructions	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Visual biofeedback with the use of sensorized insoles; Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol. The experimental group was re-educated to the correct gait dynamics by wearing the sensorized insoles and by using a specific software's graphical interface as a visual biofeedback.
Active Comparator: Control Group The Control Group followed verbal instructions of physiotherapist during training.	Other: Standard rehabilitation based on physiotherapist's verbal instructions; Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol.The Control group did not wear the insoles, but it carried out the rehabilitation programme under the physiotherapist supervision and with his verbal feedbacks.

Outcome Measures

Primary Outcome Measures

1. Weight Bearing Absolute difference between lower limbs (ΔWBA) [between the 4th and the 10th day post surgery]

   Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform

2. Weight Bearing Percentage difference between lower limbs (ΔWBP) [between the 4th and the 10th day post surgery]

   Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform

3. Weight Bearing Percentage Healthy limb (WBPH) [between the 4th and the 10th day post surgery]

   Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform

4. Weight Bearing Percentage Surgical limb (WBPS) [between the 4th and the 10th day post surgery]

   Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform

5. Weight Bearing Absolute Healthy limb (WBAH) [between the 4th and the 10th day post surgery]

   Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform

6. Weight Bearing Absolute Surgical limb (WBAS) [between the 4th and the 10th day post surgery]

   Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform

Secondary Outcome Measures

1. Mid Step Length Healthy limb (MSLH) [between the 4th and the 10th day post surgery]

   Mid Step Length Healthy limb in mm as reported by the stabilometric platform

2. Mid Step Length Surgical limb (MSLS) [between the 4th and the 10th day post surgery]

   Mid Step Length Surgical limb in mm as reported by the stabilometric platform

3. Sway Healthy limb (SWH) [between the 4th and the 10th day post surgery]

   Sway Healthy limb in mm as reported by the stabilometric platform

4. Sway Surgical limb (SWS) [between the 4th and the 10th day post surgery]

   Sway Surgical limb in mm as reported by the stabilometric platform

5. Double Support Time (DST) [between the 4th and the 10th day post surgery]

   Double Support Time in ms as reported by the stabilometric platform

6. Numeric Rating Scale (NRS) [between the 4th and the 10th day post surgery]

   Numeric Rating Scale

7. Six Minutes Walking Test (6MWT) [between the 4th and the 10th day post surgery]

   Six Minutes Walking Test in m

8. World Health Organization Quality of Life Questionnaire (WHOQOL) [between the 4th and the 10th day post surgery]

   World Health Organization Quality of Life Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Città di Pavia" University Hospital, Pavia, Italy	Pavia		Italy	27100

Sponsors and Collaborators

• University of Pavia

Investigators

• Principal Investigator: Luca Marin, PhD, University of Pavia, Pavia, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luca Marin, Principal Investigator, University of Pavia
• ClinicalTrials.gov Identifier: NCT04268082
• Other Study ID Numbers: 20180036031
• First Posted: Feb 13, 2020
• Last Update Posted: Feb 13, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight

Study Results

No Results Posted as of Feb 13, 2020