Recruiting

Positive Pressure Treadmill

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT04747444

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Anti-Gravity Treadmill

Study Details

Brief summary:

Our goal is to compare the serum biomarker changes of joint disease that occur in response to partially off-loaded (50%) walking exercise to regular (100%) walking exercise while on a Lower Body Positive Pressure (LBPP) treadmill. Secondly we are determining the relationship between changes in the concentration of these serum biomarkers and participant reported knee pain while walking on a LBPP treadmill.

Conditions

Knee Osteoarthritis

Study ID

NCT04747444

Start date

Jun 1, 2019

Status verified date

Feb, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 50 years
  • Diagnosis of unilateral or bilateral knee osteoarthritis
  • Clinical AND/OR radiographic knee osteoarthritis.

Exclusion Criteria:

  • Age < 50 years
  • History of lower extremity total joint arthroplasty
  • Current cardiovascular disease or hypertension that is uncontrolled
  • History of neurological disorder that effects lower extremity function (i.e., stroke, peripheral neuropathy, multiple sclerosis, Parkinson's disease)
  • Current ankle or hip pain
  • Currently pregnant for female participants
  • Weight over 400 lbs (181.4 kg), height less than 4'8" (142 cm) or over 6'4" (193 cm), 18.5" (47 cm) hip width, or 58" (147 cm) hip circumference

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: 100% body weight walking

Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 100% full body weight loading

other: 50% body weight walking

Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 50% full body weight loading

Interventions

Anti-Gravity Treadmill

Treadmill in which the body weight percent placed on the lower extremities can be controlled

Primary outcome measure

  • Change in Cartilage oligomeric matrix protein serum concentration [ Time Frame: baseline, and 45 minutes of walking ]
  • Change in Knee Joint Pain [ Time Frame: baseline, and 45 minutes of walking ]

Central Contacts and Locations

Central contacts

Prakash Jayabalan, MD, PhD

3122387326pjayabalan@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Prakash Jayabalan

312-238-7326pjayabalan@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Feb 10, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2021-02-10.