Instrumental Versus Standard Rehabilitation for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178380
• Other study ID #: knee osteoarthritis
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Mohammed V Souissi University
• Contact: Houda EL Moudane, phd student
• Phone: 0624016813
• Email: houda.0elmoudane[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Morocco	Houda EL Moudane	Rabat
Morocco	Houda EL Moudane	Salé

Sponsors (2)

Lead Sponsor	Collaborator
Mohammed V Souissi University	Ibn Sina University Hospital, Rabat, Morocco

Country where clinical trial is conducted

Morocco, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Joint amplitude measurements	using a goniometer to evaluate the extent of knee flexion and extension	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	muscle testing of hamstring and quadriceps using an isokinetic dynamometer	peak torque in newtons and body weight in newtons per kilogram	12 weeks
Secondary	walking test	support symmetry in percentage and step length in centimeters	12 weeks

External Links

•   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 pathology