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Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

Primary Purpose

Gonarthrosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
traditional rehabilitation protocol
with instrumented Orthosis
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gonarthrosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Person who signed informative consent
  • Affiliated with the social security
  • Male and female aged between 50 and 80
  • Walk without assistance
  • Smartphone's use

Exclusion criteria:

  • Person under protective measure
  • Orthopedics issues
  • Neurologic issues (MMSE Test < 24)
  • Knee or hip prothesis
  • Person with NSAIDs and analgesics treatment with an effective intake less than 48 hours before the evaluation
  • Predominant patello-femoral arthritis
  • Symptomatic hip OA
  • Knee infection
  • Knee injuries

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

with instrumented Orthosis

without instrumented Orthosis

Arm Description

patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated

patient will follow 8 weeks of traditional muscular strengthening without orthosis

Outcomes

Primary Outcome Measures

Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation
Assessment of knee external knee moment abduction

Secondary Outcome Measures

Full Information

First Posted
January 7, 2020
Last Updated
January 9, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04225182
Brief Title
Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
Official Title
Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The management of knee osteoarthritis via a physical activity protocol for rehabilitation has convincing results. However, the effectiveness of these protocols could be improved with a connected instrumented knee brace with an exercise protocol adapted for the patient which is supervise by an online physiotherapist to check the progression during home-based rehabilitation.
Detailed Description
The management of knee osteoarthritis via physical activity protocol for rehabilitation has convincing results. The aim of this study is to determine the improvement of the effectiveness of a home-based rehabilitation with and without instrumented knee brace for moderated gonarthrosis patients. The study will focus during one years on 80 moderated gonarthrosis patients with a Kellgren and Lawrence (K&L) score between 2 and 3, aged between 50 and 80. Each patient will practice an 8 weeks progressive home exercise program with 3 session per weeks. The effectiveness of this protocol will be quantified with a gait analysis with kinematics, kinetics and electromyography, before and after the progressive home exercise protocol. The statistical analysis will focus on ANOVA and correlation between control group and instrumented knee brace group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with instrumented Orthosis
Arm Type
Experimental
Arm Description
patient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated
Arm Title
without instrumented Orthosis
Arm Type
Active Comparator
Arm Description
patient will follow 8 weeks of traditional muscular strengthening without orthosis
Intervention Type
Device
Intervention Name(s)
traditional rehabilitation protocol
Intervention Description
muscular strengthening protocol with traditional rehabilitation protocol without orthosis
Intervention Type
Device
Intervention Name(s)
with instrumented Orthosis
Intervention Description
8 weeks of muscular strengthening with the orthosis connected to the phone app associated
Primary Outcome Measure Information:
Title
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation
Description
Assessment of knee external knee moment abduction
Time Frame
At the baseline (inclusion) and after 8 weeks of muscular strengthening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Person who signed informative consent Affiliated with the social security Male and female aged between 50 and 80 Walk without assistance Smartphone's use Exclusion criteria: Person under protective measure Orthopedics issues Neurologic issues (MMSE Test < 24) Knee or hip prothesis Person with NSAIDs and analgesics treatment with an effective intake less than 48 hours before the evaluation Predominant patello-femoral arthritis Symptomatic hip OA Knee infection Knee injuries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier GUERIN, MD
Phone
0492034394
Email
guerin.o@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic CHORIN, PhD
Phone
0492034924
Ext
0033
Email
chorin.f@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GUERIN, MD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

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