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RecruitingNCT06178380Updated Jan 23, 2024

Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

An interventional study of rehabilitation in Knee Osteoarthritis, sponsored by Mohammed V Souissi University. Recruiting at 2 sites in Morocco. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Mohammed V Souissi University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 4 months after the study started (first participant enrolled Jul 2021, registered Nov 2023).
  • Started Jul 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • rehabilitation
  • knee
  • osteoarthritis
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 60 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Mohammed V Souissi University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with radiologically confirmed uni/ bilateral gonarthrosis

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    standard rehabilitation

    rehabilitation of knee osteoarthritis patients using standard techniques of massage, stretching, muscle strengthening and balance work

    Other: rehabilitation

  • Experimental
    instrumental rehabilitation

    rehabilitation of knee osteoarthritis patients using isokinetic, posturograph and antigravity treadmill

    Other: rehabilitation

Interventions

  • Otherrehabilitation

    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

06

What researchers measure

Primary outcomes

  1. Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

    Time frame: 12 weeks

Secondary outcomes

  1. Joint amplitude measurements

    using a goniometer to evaluate the extent of knee flexion and extension

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. time up and go

    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.

    Time frame: 12 weeks

  4. the Visual Analog Scale

    the Visual Analog Scale (VAS), a graded scale ranging from 0 to 100 millimeters, 0 no pain and 100 severe pain

    Time frame: 12 weeks

  5. quality of life index

    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.

    Time frame: 12 weeks

  6. results of balance plateform assessement

    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

    Time frame: 12 weeks

  7. muscle testing of hamstring and quadriceps using an isokinetic dynamometer

    peak torque in newtons and body weight in newtons per kilogram

    Time frame: 12 weeks

  8. walking test

    support symmetry in percentage and step length in centimeters

    Time frame: 12 weeks

07

Study locations

2 of 2 sites recruiting
  • Houda EL Moudane
    Rabat, Morocco
    Recruiting
    • Houda EL Moudane, phd student · Contacthouda.0elmoudane@gmail.com · 0624016813
    • Houda EL Moudane, phd student · Principal investigator
  • Houda EL Moudane
    Salé, Morocco
    Recruiting
    • Houda EL Moudane, phd student · Contacthouda.0elmoudane@gmail.com · 0624016813
    • Houda EL Moudane, phd student · Principal investigator
08

References and documents

Publications

  • 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. PubMed 29035179 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06178380
Lead sponsor
Mohammed V Souissi University
Collaborators
Ibn Sina University Hospital, Rabat, Morocco
Responsible party
EL Moudane Houda (principal Investigator, Mohammed V Souissi University) — Principal investigator
First posted
Dec 21, 2023
Start date
Jul 1, 2021
Primary completion
Jun 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jan 23, 2024

Study contacts

Houda EL Moudane, phd student
Contact
houda.0elmoudane@gmail.com
0624016813
Houda EL Moudane, phd student
principal investigator · Mohammed V Souissi University
Samia KARKOURI, PROFESSOR
study director · Mohammed V Souissi University
Latifa TAHIRI, PROFESSOR
study director · Mohammed V Souissi University
Sara SKALLI, Doctor
study chair · Mohammed V Souissi University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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