Clinical trial NCT06178380: Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis
Official title: Clinical and Instrumental Biomechanical Assessement and Rehabilitation of Patients With Knee Osteoarthritis:A Randomized Single Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: rehabilitation
knee
osteoarthritis
Lead sponsor: Mohammed V Souissi University
Sponsor class: OTHER
Collaborators: name: Ibn Sina University Hospital, Rabat, Morocco
First posted: 2023-12-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized single blind clinical trial is a research study design used to evaluate the effectiveness of a medical intervention or treatment. In this type of trial, participants are randomly assigned to one of two a more groups, one groupe receives the experimental treatment, while the other group may receive a placebo or standard treatment, depending on the study's design

- the term "single blind" refers to the fact that , in this trial the participants do not know whether they are receiving the experimental treatment or a control treatment this is done to minimize the potential for bias in reporting their symptoms or outcomes
Primary purpose: OTHER

Brief summary: A randomized clinical trial to evaluate the effectiveness of an instrumental rehabilitation protocol compared with standard protocol In patients with knee osteoarthritis.

Detailed description: This is a randomized clinical trial designed to compare two intervention aimed at reducing and improving knee function in patients with knee osteoarthritis

- sixty subjects suffering from knee osteoarthritis will be recruited; 30 per group.

A: instrumental rehabilitation B:standard rehabilitation All patients who meet the clinical inclusion and exclusion criteria will have a standard radiography

* selected patients will be invited to participate and will be informed of the purpose and conduct of the study
* patients will be randomized to either the instrumental rehabilitation programme groupe or the standard rehabilitation group
* patients in both groups will have a protocol that will be extended over 6 weeks
* participants will be assessed primarily for function and pain, as well as other secondary endpoints , at baseline at 3 weeks and at 12 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with radiologically confirmed uni/ bilateral gonarthrosis

Exclusion Criteria:

* Will be excluded from our study:
* Subjects with congestive gonarthrosis (joint effusion at clinical examination).
* Patients followed for chronic inflammatory rheumatism.
* Patients who are candidates for surgery for knee osteoarthritis
* Patients with a pathology causing a limitation in walking distance apart from gonarthrosis.
* Amputees of one or both lower limbs.

Primary outcomes:
measure: Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 weeks
Secondary outcomes:
measure: Joint amplitude measurements
timeFrame: 12 weeks
measure: muscle testing of hamstring and quadriceps
timeFrame: 12 weeks
measure: time up and go
timeFrame: 12 weeks
measure: the Visual Analog Scale
timeFrame: 12 weeks
measure: quality of life index
timeFrame: 12 weeks
measure: results of balance plateform assessement
timeFrame: 12 weeks
measure: muscle testing of hamstring and quadriceps using an isokinetic dynamometer
timeFrame: 12 weeks
measure: walking test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Houda EL Moudane
city: Salé
country: Morocco
facility: Houda EL Moudane
Study officials:
affiliation: Mohammed V Souissi University
name: Houda EL Moudane, phd student
role: PRINCIPAL_INVESTIGATOR
affiliation: Mohammed V Souissi University
name: Samia KARKOURI, PROFESSOR
role: STUDY_DIRECTOR
affiliation: Mohammed V Souissi University
name: Latifa TAHIRI, PROFESSOR
role: STUDY_DIRECTOR
affiliation: Mohammed V Souissi University
name: Sara SKALLI, Doctor
role: STUDY_CHAIR
References:
citation: Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.