Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

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

Detailed Description
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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.

Official Title
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Clinical and Instrumental Biomechanical Assessement and Rehabilitation of Patients With Knee Osteoarthritis:A Randomized Single Blind Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: rehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard rehabilitation<br>rehabilitation of knee osteoarthritis patients using standard techniques of massage and stretching and muscle strengthening and balance work | Other: rehabilitation<br>* .Patients in both groups will follow a 6-week protocol. It will include: For the experimental group: Isokinetic training: 2 sessions per week for 6 weeks Antigravity treadmill: 3 sessions per week for 6 weeks Posturography: 1 session per week for 6 weeks For the control group: Patients will receive a standard rehabilitation prescription comprising: Physiotherapy for pain relief, muscle stretching and strengthening for quadriceps/hamstrings, proprioceptive exercises, and self-programmed walking exercises. The use of a level 1 or 2 pain relief treatment will be allowed in case of significant pain.<br>|
| Experimental: instrumental rehabilitation<br>rehabilitation of knee osteoarthritis patients using isokinetic devices to strengthen the hamstrings and quadriceps and balance work using the posturograph and walking using the antigravity treadmill | Other: rehabilitation<br>* .Patients in both groups will follow a 6-week protocol. It will include: For the experimental group: Isokinetic training: 2 sessions per week for 6 weeks Antigravity treadmill: 3 sessions per week for 6 weeks Posturography: 1 session per week for 6 weeks For the control group: Patients will receive a standard rehabilitation prescription comprising: Physiotherapy for pain relief, muscle stretching and strengthening for quadriceps/hamstrings, proprioceptive exercises, and self-programmed walking exercises. The use of a level 1 or 2 pain relief treatment will be allowed in case of significant pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | WOMAC: is a valited self questionnaire for knee osteoarthritis, consisting of 24 items divised into 3 subscales: Pain: assessed by 5 items Stifness: assessed by 2 items Physical functioning: assessed by 17 items Wi will used the lickert scale for scoring, with 5 possible responses (none=0; minimal=1; moderate=2; Severe=3; extreme=4). The score ranges from 0 (normal knee) to 96 points ( major knee in daily life) WOMAC: is a valited self questionnaire for knee osteoarthritis, consisting of 24 items divised into 3 subscales: Pain: assessed by 5 items Stifness: assessed by 2 items Physical functioning: assessed by 17 items Wi will used the lickert scale for scoring, with 5 possible responses (none=0; minimal=1; moderate=2; Severe=3; extreme=4). The score ranges from 0 (normal knee) to 96 points ( major knee in daily life) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint amplitude measurements | using a goniometer to evaluate the extent of knee flexion and extension | 12 weeks | 
| muscle testing of hamstring and quadriceps | Muscle testing is employed to assess hamstring and quadriceps strength on a qualitative scale ranging from 0 to 5 | 12 weeks | 
| time up and go | is utilized to evaluate patient mobility and balance, measured in seconds. | 12 weeks | 
| VAS pain | the Visual Analog Scale (VAS), a graded scale ranging from 0 to 10 | 12 weeks | 
| quality of life index | the SF12 questionnaire is administered to assess quality of life | 12 weeks | 
| results of balance plateform assessement | assessing the surface area of the confidence ellipse (mm²), length of the stabilogram (mm), x and y coordinates of the center of pressure (mm), area ratio, and perimeter ratio | 12 weeks | 
| muscle testing of hamstring and quadriceps using an isokinetic dynamometer | to assess peak torque in newtons and body weight in newtons/kg, as well as to evaluate right-left deficits | 12 weeks | 
| walking test | measurements from an anti-gravity treadmill, including percentage of weight-bearing symmetry and step length in cm | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, knee, osteoarthritis