Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

NCT05585099 | Unknown

• 1 other identifier: 22-07-07
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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 \[improve in knee pain, physical function, and quadriceps muscles strength\]

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Numeric pain rating scale

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

  Change from baseline pain at 6 weeks

• Knee injury and osteoarthritis outcome score (KOOS)

  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.

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

• Thigh muscle strength test

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

  Change from baseline thigh muscle strength at 6 weeks.

Secondary Outcomes (10)

• 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.

• 4 square step test

  Change from baseline dynamic balance and coordination at six weeks

• Functional reach test

  Change from baseline static balance at six weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Participants will walk in retro walking exercise on lower body positive pressure treadmill.

Other: Exercise

Control

OTHER

Participants will walk in forward walking exercise on lower body positive pressure treadmill.

Other: Exercise

Interventions

Exercise OTHER

Participants will stand on lower body positive pressure treadmill and participate in walking exercise.

Also known as: Walking exercise

Control; Experimental

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant
• Other conditions that are Contra indication to lower body positive pressure.

Sponsors & Collaborators

• Qassim University: lead

Study Sites (2)

Qassim university medical city

Buraidah, Almuledia, 52373, Saudi Arabia

RECRUITING

Medical City in Qassim University

Buraidah, Saudi Arabia

RECRUITING

Related Publications (1)

• Almutairi SM, Almutairi MK, Alotaibi MM, Alshehri M, Alenazi AM. Effects of backward walking exercise using lower body positive pressure treadmill on knee symptoms and physical function in individuals with knee osteoarthritis: a protocol for RCT. J Orthop Surg Res. 2023 Apr 1;18(1):264. doi: 10.1186/s13018-023-03711-x.

  PMID: 37005596 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sattam M Almutairi, Ph.D

CONTACT

+966505102644; A.sattam@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 18, 2022
• Study Start: June 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)