Knee OsteoarthritisNCT06178380
Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis
A study testing rehabilitation in people with Knee Osteoarthritis, run by Mohammed V Souissi University at 2 sites in Morocco.
Trial summary
A randomized clinical trial to evaluate the effectiveness of an instrumental rehabilitation protocol compared with standard protocol In patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesMorocco
- Study dates
- 1 Jul 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with radiologically confirmed uni/ bilateral gonarthrosis
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Morocco2 sites, 2 recruiting
- Recruiting
Houda EL Moudane
Rabat
Houda EL Moudane, phd student, 0624016813, houda.0elmoudane@gmail.com
Houda EL Moudane, phd student
- Recruiting
Houda EL Moudane
Salé
Houda EL Moudane, phd student, 0624016813, houda.0elmoudane@gmail.com
Houda EL Moudane, phd student
About this study
Official title: 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.
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- rehabilitation
- Keywords
- rehabilitation, knee, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| standard rehabilitation | Active comparator | rehabilitation of knee osteoarthritis patients using standard techniques of massage, stretching, muscle strengthening and balance work Receives: Other: rehabilitation |
| instrumental rehabilitation | Experimental | rehabilitation of knee osteoarthritis patients using isokinetic, posturograph and antigravity treadmill Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
Joint amplitude measurements
using a goniometer to evaluate the extent of knee flexion and extension
Measured: 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
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
muscle testing of hamstring and quadriceps using an isokinetic dynamometer
peak torque in newtons and body weight in newtons per kilogram
Measured: 12 weeks
walking test
support symmetry in percentage and step length in centimeters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jul 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed V Souissi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Sina University Hospital, Rabat, Morocco
- Responsible party
- Principal investigator, EL Moudane Houda, Mohammed V Souissi University
- Investigators
- Houda EL Moudane, phd student, Principal investigator, Mohammed V Souissi UniversitySamia KARKOURI, PROFESSOR, Study director, Mohammed V Souissi UniversityLatifa TAHIRI, PROFESSOR, Study director, Mohammed V Souissi UniversitySara SKALLI, Doctor, Study chair, Mohammed V Souissi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178380
- Sponsor's protocol ID
- knee osteoarthritis
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Biomechanical Assessement and Rehabilitation of Patients With Knee Osteoarthritis:A Randomized Single Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06178380
- Acronym / sponsor ID
- knee osteoarthritis
- Conditions
- Knee Osteoarthritis
- Keywords
- rehabilitation, knee, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed V Souissi UniversityUniversity, hospital or other
- Collaborators
- Ibn Sina University Hospital, Rabat, Morocco
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| standard rehabilitation | Active comparator | Other: rehabilitationrehabilitation of knee osteoarthritis patients using standard techniques of massage, stretching, muscle strengthening and balance work |
| instrumental rehabilitation | Experimental | Other: rehabilitationrehabilitation of knee osteoarthritis patients using isokinetic, posturograph and antigravity treadmill |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with radiologically confirmed uni/ bilateral gonarthrosis
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitationFor 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 | Other | instrumental rehabilitation, standard rehabilitation |
Primary outcome
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.
8 secondary outcomes
Joint amplitude measurements
Time frame: 12 weeks
muscle testing of hamstring and quadriceps
Time frame: 12 weeks
time up and go
Time frame: 12 weeks
the Visual Analog Scale
Time frame: 12 weeks
quality of life index
Time frame: 12 weeks
results of balance plateform assessement
Time frame: 12 weeks
muscle testing of hamstring and quadriceps using an isokinetic dynamometer
Time frame: 12 weeks
walking test
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Results publication: PubMed 29035179Lespasio 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.
- on this site we will find the definition of osteoarthritis of the knee and the risk factors as well as the diagnosis and treatment of this pathologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Knee Osteoarthritis, run by Mohammed V Souissi University at 2 sites in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Houda EL Moudane, phd student (0624016813, houda.0elmoudane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.