NCT05855681

Brief Summary

The goal of this clinical trial is to investigate the effect of adding strengthening exercise for hip rotators and ankle muscles to knee exercises on pain, function, muscles strength , and knee proprioception in patients with knee osteoarthritis. The main question it aims to answer is:

  • What is the effect of adding strengthening exercise for hip rotators and ankle muscles to knee exercises on pain, function, strength of hip rotators and ankle muscles, and knee proprioception in patients with knee osteoarthritis?" Adult male and female diagnosed with unilateral or bilateral knee osteoarthritis, referred from orthopedic surgeons according to inclusion and exclusion criteria will be enrolled in this study, randomly allocated to groups and received exercise for 4 weeks.
  • Control group Patients in this group will receive knee exercises in the form of stretching for hamstring and calf. Strengthening exercises in form of strengthening exercise for quadriceps.
  • Experimental group In addition to the same knee exercise of control group patients will receive strengthening exercise for hip rotators and ankle muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

May 4, 2023

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • pain level

    assessed by visual analogue scale

    4 weeks

  • functional level

    assessed by Knee injury and Osteoarthritis Outcome Score

    4 weeks

  • knee proprioception

    assessed by joint position sense

    4 weeks

Secondary Outcomes (3)

  • Hip internal and external rotator strength

    4 weeks

  • Ankle dorsi flexors, planter flexor, invertor and evertor strength

    4 weeks

  • Quadriceps strength

    4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

patients will receive strengthening exercise for hip rotators and ankle muscles in addition to quadriceps strengthening . stretching exercise for hamstring and calf muscle also will be received

Other: therapeutic exercises

control group

OTHER

patients will receive strengthening exercises for quadriceps and stretching exercise for hamstring and calf muscle.

Other: therapeutic exercises

Interventions

strengthening exercise and stretching exercise

control groupexperimental group

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic Knee osteoarthritis with pain for more than 3 months.
  • Age between 40-55 years .
  • BMI 25 - 34.9
  • Kellgren \_ Lawrence grad1,2,3 .
  • Subjects must be referred to the outpatient clinic of the faculty of Physical Therapy, Cairo University with a confirmed diagnosis of unilateral or bilateral (knee with primary affection included) knee osteoarthritis and having one or more of the following criteria:
  • Morning stiffness for less than 30 min.
  • Crepitus on active knee movement.
  • Palpable or radiographic bony enlargement.
  • Tenderness at joint margins or joint line.
  • Knee pain over 30 mm on the Visual analogue scale.

You may not qualify if:

  • \- 1- Physical therapy treatment for hip, knee and ankle in the last month. 2-Steroid knee injections in the previous 3 months. 3- hyaluronic acid intraarticular injections in the previous 6 months. 4- History of knee, ankle or hip surgery in the last 2 years. 5- Severe knee malalignment in varus or valgus that requires use of any gait-assistive device.
  • Neurological disease in lower limb 7- Inflammatory arthritis (eg: rheumatoid arthritis). 8- Ankle instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes Assessor) (assessor by research assistant, patients and statistician)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Triple blinded Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 11, 2023

Study Start

August 1, 2023

Primary Completion

October 15, 2023

Study Completion

October 15, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations