Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.

July 27, 2020 updated by: Foundation University Islamabad
Knee osteoarthritis is a very common disorder affecting majority of elderly population. There is considerable functional disability associated with this disorder. The financial burden associated with this disease is quite high. Although various forms of pharmacologic and non pharmacologic therapies exist for its management, but most of these interventions only deal with symptoms without taking into account the associated factors aggravating the condition. Research suggests that abnormal loading of an arthritic joint will only increase the pain and disability. Participation in a regular exercise program involving weight bearing activities is a successful way to reduce or prevent decline in functional abilities. But the major problem with this approach lies in its abnormal loading of joint leading to altered biomechanics resulting in more joint damage. To counter this problem, lower body positive pressure or anti gravity treadmills have been designed. These treadmills provide up to 80% body weight support, thus considerably un-weighing the joint while retaining proper joint biomechanics. So with the help of this specialized training unit, elderly population will be better equipped to cope with arthritic changes leading to greater functional independence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis is a very common chronic joint disease resulting in functional disability. Knee OA is considered to be most common form of arthritis in western countries. Knee OA is mainly characterized by presence of pain, radiographic evidence of reduced joint space, wear and tear of articular cartilage and formation of osteophytes i.e., new bone formation at the center and margins of joint. Pain and resultant joint changes causes a change in joint biomechanics and an eventual disuse of limb leading to muscle weakness and atrophy. According to an estimate from a study, knee OA nearly affects 10% of people older than 55 years of age, resulting in severe functional disability in a quarter of this affected population. In elderly population, knee OA poses almost the same risk of disability as caused by heart disease and a larger threat than due to any other medical condition. The prevalence of OA is reported to be as high as 28% in urban and 25% in rural areas of Pakistan.

Literature on knee OA treatment suggest that weight bearing activities in the form of walking are useful in the management of joint symptoms. Loading across the joint must be optimal so that there is no abnormal stress on any compartment of the joint. Abnormal valgus and varus stress results in 4 fold and 5 fold increase in lateral and medial compartments OA of the knee respectively. But this increased loading on an already worn joint can cause considerable pain and damage to the joint. For this purpose, aquatic exercises and hydrotherapy are usually used to counteract the forces acting on the joint. Then there are different types of harness systems and robotic devices to physically lift the patients for unloading the joint. But the problem with these interventions is that they do not account for proper joint kinematics necessary for optimal distribution of forces across the joints. For this purpose, anti gravity treadmills or lower body positive pressure treadmills are designed which take into account the proper joint kinematic s while partially un-weighing the joint. These treadmills are based on NASA technology used for astronauts to counteract the joint problems experienced by them.

These treadmills consist of an air tight chamber surrounding the lower body in which increased pressure is applied, so that the treadmill causes an upward lifting force. This results in successfully decreasing the body weight and gravitational forces on the lower extremity to an adjustable level with a high degree of consistency. Body weight can then be adjusted to as small increments as 1% and as large as 80% by using positive air pressure. This method is considered superior to other methods of un-weighing (harness systems and aquatic therapy) because there is uniform application of pressure over the lower limbs, thereby decreasing the creation of pressure points (common with harness systems) while retaining normal muscle activation and gait patterns (which are changed during water based activities).

This study will help the patients suffering from osteoarthritis to rehabilitate in a pain free environment focusing on proper joint kinematics.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 46000
        • Foundation University Institute of Rehabilitation Sciences.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female
  • Age group 50-75 years
  • Knee osteoarthritis GI, GII and G III (Kellgren & Lawrence system).

Exclusion Criteria:

  • Traumatic arthritis
  • Unstable cardiovascular state
  • Neuro-muscular disorders involving the lower extremity
  • History of surgery of lower limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti gravity treadmill training
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization followed by Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes.
Device: Anti gravity treadmill training
Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes
Other Names:
  • Lower Body Positive Pressure (LBPP) treadmill training
Procedure: Physical Therapy
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization
Active Comparator: Control
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization only
Procedure: Physical Therapy
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: 4 weeks
Numeric Pain Rating Scale will be used to measure patient's self perceived pain.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 4 weeks
Knee Injury and Osteoarthritis Outcome Score will be used to assess patients symptoms, physical functioning and quality of life.
4 weeks
36-Item Short Form Survey for Quality of Life
Time Frame: 4 weeks
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Collaborators

Higher Education Commission (Pakistan)

Investigators

  • Principal Investigator: Aamer Naeem, BSPT, PPDPT, MSOMPT, PhD*, Foundation University Islamabad
  • Principal Investigator: Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*, Foundation University Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2020/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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