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Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06178380
Enrollment
60
Registered
2023-12-21
Start date
2021-07-01
Completion date
2024-12-01
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

rehabilitation, knee, osteoarthritis

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.

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

Sponsors

Ibn Sina University Hospital, Rabat, Morocco
CollaboratorOTHER
Mohammed V Souissi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)12 weeksThe 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.

Secondary

MeasureTime frameDescription
muscle testing of hamstring and quadriceps12 weeksMuscle testing is employed to assess hamstring and quadriceps strength on a qualitative scale ranging from 0 to 5
time up and go12 weeksis 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.
the Visual Analog Scale12 weeksthe Visual Analog Scale (VAS), a graded scale ranging from 0 to 100 millimeters, 0 no pain and 100 severe pain
Joint amplitude measurements12 weeksusing a goniometer to evaluate the extent of knee flexion and extension
results of balance plateform assessement12 weeksthe 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
muscle testing of hamstring and quadriceps using an isokinetic dynamometer12 weekspeak torque in newtons and body weight in newtons per kilogram
walking test12 weekssupport symmetry in percentage and step length in centimeters
quality of life index12 weeksthe 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.

Countries

Morocco

Contacts

Primary ContactHouda EL Moudane, phd student
houda.0elmoudane@gmail.com0624016813

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026