NCT05941117

Brief Summary

This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

June 25, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change happened in the dynamic balance from the baseline

    Biodex Balance System which is a device used to measure the balance of a person who stand on the platform of the device that give a measurement called over all stability index where 0 score means the best balance and the largest number indicate bad balance.

    one day after the end of treatment

Secondary Outcomes (2)

  • change happened in pain from the baseline

    one day after the end of treatment

  • change happened in the joint angle repositioning from baseline

    one day after the end of treatment

Study Arms (2)

weight bearing exercises group

ACTIVE COMPARATOR

20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises.

Combination Product: stretching exercisesCombination Product: Transcutaneous electrical nerve stimulationCombination Product: weight bearing strengthening exercises

non-weight bearing exercises group

ACTIVE COMPARATOR

20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises.

Combination Product: stretching exercisesCombination Product: Transcutaneous electrical nerve stimulationCombination Product: Non-weight bearing strengthening exercises

Interventions

stretching exercisesCOMBINATION_PRODUCT

stretching exercises for Hamstring, quadriceps and calf muscle for both lower limbs of the same patients. each exercise was repeated 5 times and each repetition hold for 30 seconds in the same session.

non-weight bearing exercises groupweight bearing exercises group

it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.

Also known as: TENS
non-weight bearing exercises groupweight bearing exercises group

strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of weight bearing from standing position each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.

weight bearing exercises group

strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of non-weight bearing from lying and setting positions each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.

non-weight bearing exercises group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient's age \> 50 years.
  • Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L).
  • Body mass index (BMI) from 20 to 30 kg/m2.
  • Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.
  • knee pain \> 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week.
  • Bilateral knee osteoarthritis.

You may not qualify if:

  • Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee.
  • Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests.
  • Intra articular knee injection of steroids in the past 6 months.
  • Patients who had received joint replacement surgery in either Knee or hip.
  • Patients with rheumatoid arthritis.
  • Patients who received physical therapy sessions on the knee in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching ExercisesTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD candidate

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 12, 2023

Study Start

October 25, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations