NCT06110104

Brief Summary

Osteoarthritis is one of the most common degenerative joint disease that affects approximately more than 300 million people worldwide

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

quadriceps torque,quadriceps endurance,balance,funcitional disability.

Outcome Measures

Primary Outcomes (4)

  • quadriceps torque

    hand-held dynamometer offers a reliable and valid method to quantify quadriceps strength in a clinical environmen .quadriceps peak torque obtained with an HHD is valid compared to an isokinetic dynamometer. it offers a less expensive and time-consuming way to obtain measures in a clinical environment. The torque peak (Nm) of the quadriceps will be measured by multiplying the force, acceleration of gravity and lever arm: \[force (kg) × 9.81 × lever arm (m)\]. Quadriceps torque (Nm) data were normalized by the body mass (kg) of each participant: torque (Nm)/body mass (kg).

    6 weeks

  • quadriceps endurance

    Fatigue resistance test assesses Quadriceps isometric endurance .The individuals will sit on a chair with their back straight and their hips and knees flexed at 90 degrees. A 5 kg weight will be secured with tape above the ankle (testing side), and leg alignment In relation to the horizontal plane measured by digital inclinometer.A stopwatch will use to record the time. The duration of time spent in this position is used to determine their knee extensor endurance capacity. If the knee extension position shifted at least five degrees from the horizontal plane , or the participant could not sustain the test leg in a horizontal position due to pain or fatigue, the test will be terminated.This Endurance testing protocol will be repeated three times, and the best effort will be taken for analysis. There is a rest period of three minutes between each testing trial. The same investigator will record the individuals' readings.

    6 weeks

  • balance

    Balance in knee osteoarthritis will be measured by Time up and go test During the test, all participants were asked to stand up from a chair without armrests and with a seat height of 44 cm, walk at a comfortable pace to a line 3 m away, cross the line and turn through 180°, walk back, and sit in their starting position. The use of an assistive device was allowed for those using one, but no verbal encouragement or personal assistance was given. After one pilot test, the average time of the two successive trials was recorded using a timer with an accuracy of 1/100 s.

    6 weeks

  • knee functional disability

    Functional disability will be assessed using the Arabic version of the Western Ontario and McMaster Universities Osteoarthritis index. The pain subscale includes five questions about pain .The stiffness subscale includes two questions about stiffness . The physical function subscale includes 17 questions about the degree of difficulty .Each of the 24 questions is graded either on a five-point Likert scale (0 to 4) or a 100 mm visual analogue scale (VAS)9ranging from 0 (no pain) to 100 (extreme pain).

    6 weeks

Study Arms (3)

control group

EXPERIMENTAL

they recieve Routine physiotherapy program comprises a combination of closed kinetic chain and open kinetic chain exercises, including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and leg press for 6 weeks.

Other: routine physiotherapy program for knee osteoarthritis

Retro-walking group

EXPERIMENTAL

they recieve routine physiotherapy and Retro-walking program which is about 10 min of supervised retro walking training 3 days a week for 6 weeks at their comfortable walking speed . The participants will be instructed to gradually increase their walking time up to 30 min over the 6-week period.

Other: routine physiotherapy program for knee osteoarthritisOther: Retro-walking program

whole body vibration group

EXPERIMENTAL

they recieve routine physiotherapy and whole body vibration which is 3 days per week for 6 weeks. During the training, the participants will perform static squat training barefoot on the platform with bent knees (30° and 60°). The distance between the feet was consistent with the shoulders. the duration time, sets and total time will be increased progressively over the 6-week.

Other: routine physiotherapy program for knee osteoarthritisOther: whole body vibration training

Interventions

The Routine physiotherapy program comprises a combination of closed kinetic chain and open kinetic chain exercises, including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and leg press for 6 weeks.

Retro-walking groupcontrol groupwhole body vibration group

Retro-walking program is about 10 min of supervised retro walking training 3 days a week for 6 weeks at their comfortable walking speed . The participants will be instructed to gradually increase their walking time up to 30 min over the 6-week period.

Retro-walking group

whole body vibration is 3 days per week for 6 weeks. During the training, the participants will perform static squat training barefoot on the platform with bent knees (30° and 60°). The distance between the feet was consistent with the shoulders. the duration time, sets and total time will be increased progressively over the 6-week.

whole body vibration group

Eligibility Criteria

Age40 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe estrogen via estrogen receptor mediates osteoarthritis cartilage degradation and accelerates the progression of cartilage loss increase disease risk in females more than males.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects are required to have a radiograph of the knee joints within 2 weeks of testing.
  • Weight-bearing, fixed flexion radiographs of the knee were taken in the AP views .
  • Radiographic evidence of knee OA.according to Kellgren and Lawrence classification scale (gradeIII) as 0,Normal and 4,Sever.
  • Particepants age are 40-55 . 5.Knee pain for at least 3 month , with pain presenting at least 3 days a week during last month.
  • functional limitations (patients with pain \&stiffnes), The Arabic version of the western womac (ArWOMAC) scores (average 37) 7.ability to ambulate independently for at least 10 meters. 8.Ability to follow simple structures.

You may not qualify if:

  • (BMI) more ≥ 30. 2.History of knee surgery to knee within past 3 months 3.A systemic arthritic condition. 4.Any other muscular, joint or neurological condition affecting lower limb function.
  • Physical therapy or an intra-articular injection in the knee within the past 3 months.
  • Change in pain medications in the previous month. 7.Healthy participants, impairment conditions unrelated to gait conditions such as cardio- and respiratory-related diseases, people with lower limb amputations, and lower prosthetic limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12462, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • manal mo ismail, PHD

    Cairo University

    STUDY CHAIR
  • sara mo samir, MSc

    Cairo University

    STUDY DIRECTOR
  • Ahmed om abd el naem, MSc

    faculty of physical therapy cairouniversity

    STUDY DIRECTOR
  • marwa ga amr, BSc

    faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: interventions; the first intervention: The Routine physiotherapy program comprises a combination of closed kinetic chain and open kinetic chain exercises, including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and leg press for 6 weeks. the other intervention : Retro-walking program is about 10 min of supervised retro walking training 3 days a week for 6 weeks at their comfortable walking speed . The participants will be instructed to gradually increase their walking time up to 30 min over the 6-week period. the last intervention is whole body vibration is 3 days per week for 6 weeks. During the training, the participants will perform static squat training barefoot on the platform with bent knees (30° and 60°). The distance between the feet was consistent with the shoulders. the duration time, sets and total time will be increased progressively over the 6-week.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
cairo university

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 31, 2023

Study Start

September 11, 2023

Primary Completion

September 11, 2023

Study Completion

September 23, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations