NCT06178380

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 23, 2024

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

November 3, 2023

Last Update Submit

January 21, 2024

Conditions

Keywords

rehabilitationkneeosteoarthritis

Outcome Measures

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.

    12 weeks

Secondary Outcomes (8)

  • Joint amplitude measurements

    12 weeks

  • muscle testing of hamstring and quadriceps

    12 weeks

  • time up and go

    12 weeks

  • the Visual Analog Scale

    12 weeks

  • quality of life index

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

standard rehabilitation

ACTIVE COMPARATOR

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

Other: rehabilitation

instrumental rehabilitation

EXPERIMENTAL

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

Other: rehabilitation

Interventions

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

instrumental rehabilitationstandard rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with radiologically confirmed uni/ bilateral gonarthrosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Houda EL Moudane

Rabat, Morocco

RECRUITING

Houda EL Moudane

Salé, Morocco

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Houda EL Moudane, phd student

    Mohammed V Souissi University

    PRINCIPAL INVESTIGATOR
  • Samia KARKOURI, PROFESSOR

    Mohammed V Souissi University

    STUDY DIRECTOR
  • Latifa TAHIRI, PROFESSOR

    Mohammed V Souissi University

    STUDY DIRECTOR
  • Sara SKALLI, Doctor

    Mohammed V Souissi University

    STUDY CHAIR

Central Study Contacts

Houda EL Moudane, phd student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Masking is a technique used to keep treatment information indisclosed to the study participants while allowing researchers and treatment administration to know this information: study participants are not informed about the treatment they are receiving, they do not know whether they are receiving the experimental treatment under investigation or if they are in the control group , which may receive a placebo or standard treatment . This helps reduce potential bias related to participant expectations
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

November 3, 2023

First Posted

December 21, 2023

Study Start

July 1, 2021

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 23, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations