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

Gonarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225182
• Other study ID #: 19-PP-19
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: June 2, 2022

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• traditional rehabilitation protocol
muscular strengthening protocol with traditional rehabilitation protocol without orthosis
• with instrumented Orthosis
8 weeks of muscular strengthening with the orthosis connected to the phone app associated

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change External Knee Moment Abduction (EKAM) during gait cycle from baseline at 8 weeks after rehabilitation	Assessment of knee external knee moment abduction	At the baseline (inclusion) and after 8 weeks of muscular strengthening