Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

January 21, 2024 updated by: EL Moudane Houda, Mohammed V Souissi University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Morocco
      • Rabat, Morocco
        • Recruiting
        • Houda EL Moudane
        • Contact:
        • Principal Investigator:
          • Houda EL Moudane, phd student
      • Salé, Morocco
        • Recruiting
        • Houda EL Moudane
        • Contact:
        • Principal Investigator:
          • Houda EL Moudane, phd student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard rehabilitation
rehabilitation of knee osteoarthritis patients using standard techniques of massage, stretching, muscle strengthening and balance work
Other: rehabilitation

For the experimental group:

Isokinetic training Antigravity treadmill Posturography

For the control group:

Patients will receive a standard rehabilitation prescription comprising:

Physiotherapy , muscle stretching and strengthening , proprioceptive exercises, and self-programmed
Experimental: instrumental rehabilitation
rehabilitation of knee osteoarthritis patients using isokinetic, posturograph and antigravity treadmill
Other: rehabilitation

For the experimental group:

Isokinetic training Antigravity treadmill Posturography

For the control group:

Patients will receive a standard rehabilitation prescription comprising:

Physiotherapy , muscle stretching and strengthening , proprioceptive exercises, and self-programmed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 12 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is an assessment tool developed to measure pain, stiffness, and physical function in individuals with osteoarthritis, primarily in the knee and hip. Patients' responses to each question are typically scored on a scale ranging from 0 to 4, where 0 signifies "no symptoms" and 4 signifies "severe symptoms." Scores obtained in each subscale can be combined to provide a total score or used individually to assess specific aspects of osteoarthritic symptoms.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint amplitude measurements
Time Frame: 12 weeks
using a goniometer to evaluate the extent of knee flexion and extension
12 weeks
muscle testing of hamstring and quadriceps
Time Frame: 12 weeks
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
Time Frame: 12 weeks

is utilized to evaluate patient mobility and balance, measured in seconds,Less than 13.5 seconds: Low risk of falling; the person has good walking speed and functional mobility.

13.5 seconds or more: High risk of falling; the person does not have good walking speed or functional mobility.
12 weeks
the Visual Analog Scale
Time Frame: 12 weeks
the Visual Analog Scale (VAS), a graded scale ranging from 0 to 100 millimeters, 0 no pain and 100 severe pain
12 weeks
quality of life index
Time Frame: 12 weeks
the SF12 questionnaire is administered to assess quality of life,The minimum value is 0, and the maximum value is 100,Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
12 weeks
results of balance plateform assessement
Time Frame: 12 weeks
the surface area of the confidence ellipse in square millimeters , length of the stabilogram in millimeters, x and y coordinates of the center of pressure in millimeters
12 weeks
muscle testing of hamstring and quadriceps using an isokinetic dynamometer
Time Frame: 12 weeks
peak torque in newtons and body weight in newtons per kilogram
12 weeks
walking test
Time Frame: 12 weeks
support symmetry in percentage and step length in centimeters
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed V Souissi University

Collaborators

Ibn Sina University Hospital, Rabat, Morocco

Investigators

  • Principal Investigator: Houda EL Moudane, phd student, Mohammed V Souissi University
  • Study Director: Samia KARKOURI, PROFESSOR, Mohammed V Souissi University
  • Study Director: Latifa TAHIRI, PROFESSOR, Mohammed V Souissi University
  • Study Chair: Sara SKALLI, Doctor, Mohammed V Souissi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Knee Osteoarthritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe