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Clinical Trials/NCT05585099
NCT05585099RecruitingNot Applicable

Effects of Retro Walking Exercise Using Lower Body Positive Pressure on Knee Pain and Physical Function in People With Knee Osteoarthritis

Qassim University3 sites in 1 country26 target enrollmentStarted: June 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
26
Locations
3
Primary Endpoint
Thigh muscle strength test

Study Overview

Brief Summary

The goal of this clinical trial is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on knee pain, physical function, and quadriceps muscle strength in people with mild to moderate knee OA. The secondary aim is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on mobility function, balance, and self-reported health outcomes in people with mild to moderate knee OA. The main questions it aims to answer are:

  • Does retro walking exercise improve knee pain, physical function and Quadriceps muscle strength compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?
  • Does retro walking exercise improve Mobility function, balance, and self-reported health outcomes compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?

Participants will walk (retro versus forward) on a lower body positive pressure treadmill.

If there is a comparison group: Researchers will compare [retro walking compares to forward walking] to see if [improve in knee pain, physical function, and quadriceps muscles strength]

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Mild to moderate knee osteoarthritis
  • Edge bigger or equal 40 years
  • Knee pain reported by participants in the past 30 days
  • One or both knees osteoarthritis graded with Kellgren & Lawrence grade 1 - 3

Exclusion Criteria

  • If they didn't meet the inclusion criteria
  • History of hip, knee or ankle injury or surgery within the last year
  • Kellgren & Lawrence grade > 3 of severe knee OA
  • Diagnosed with rheumatoid arthritis
  • History of knee injection with any medicine that reduce pain within the last year
  • History of other medical condition that would disturb normal walking function
  • Receive physical therapy in the last three months
  • Other conditions that are Contra indication to lower body positive pressure.

Outcomes

Primary Outcomes

Thigh muscle strength test

Time Frame: Change from baseline thigh muscle strength at 6 weeks.

A Biodex isokinetic dynamometer (Model 4Pro) connected to a computer will be used to assess bilateral knee's flexor and extensor isometric muscle strength.

Numeric pain rating scale

Time Frame: Change from baseline pain at 6 weeks

The NPRS is an 11-point scale with "0" representing "no pain" and "10" representing "most imaginable pain" used to assess pain intensity.

Knee injury and osteoarthritis outcome score (KOOS)

Time Frame: Change from baseline pain, symptoms, and level of disability at 6 weeks.

The KOOS is a self-reported, knee-specific questionnaire that is aimed to measure knee pain, symptoms, and level of disability during the last week.

Secondary Outcomes

  • Functional reach test(Change from baseline static balance at six weeks)
  • Patient Health Questionnaire -9(Change from baseline depression at six week)
  • 10-Meter Walk Test(Change from baseline walking speed at six weeks)
  • Rapid Assessment of Physical Activity(Change from baseline physical activity at six week)
  • 4 square step test(Change from baseline dynamic balance and coordination at six weeks)
  • 6 minute walk test(Change from baseline aerobic capacity and endurance at six week)
  • Five times sit to stand test(Change from baseline balance at 6 weeks.)
  • 3-M Backward Walk Test(Change from baseline backward walking at six weeks.)
  • Timed up and go test(Change from baseline Functional mobility at six weeks.)
  • Medical Outcomes Study Short Form 12 (SF-12)(Change from baseline quality of life at six weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sattam Almutairi

Assistant professor

Qassim University

Study Sites (3)

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