Skip to main content
Clinical Trials/NCT04225182
NCT04225182
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country65 target enrollmentStarted: January 22, 2020Last updated:
ConditionsGonarthrosis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
1
Primary Endpoint
Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation

Time Frame: At the baseline (inclusion) and after 8 weeks of muscular strengthening

Assessment of knee external knee moment abduction

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials