Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2022
CompletedMarch 24, 2026
March 1, 2026
2.4 years
January 7, 2020
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
with instrumented Orthosis
EXPERIMENTALpatient will follow 8 weeks of muscular strengthening with the orthosis connected to the phone app associated
without instrumented Orthosis
ACTIVE COMPARATORpatient will follow 8 weeks of traditional muscular strengthening without orthosis
Interventions
muscular strengthening protocol with traditional rehabilitation protocol without orthosis
8 weeks of muscular strengthening with the orthosis connected to the phone app associated
Eligibility Criteria
You may qualify if:
- Person who signed informative consent
- Affiliated with the social security
- Male and female aged between 50 and 80
- Walk without assistance
- Smartphone's use
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06000, France
Related Publications (1)
Reneaud N, Zory R, Guerin O, Thomas L, Colson SS, Gerus P, Chorin F. Validation of 3D Knee Kinematics during Gait on Treadmill with an Instrumented Knee Brace. Sensors (Basel). 2023 Feb 6;23(4):1812. doi: 10.3390/s23041812.
PMID: 36850411RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier GUERIN, MD
Nice University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 13, 2020
Study Start
January 22, 2020
Primary Completion
June 2, 2022
Study Completion
June 2, 2022
Last Updated
March 24, 2026
Record last verified: 2026-03