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

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Anti gravity treadmill training
Physical Therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anti gravity treadmill training

Control

Arm Description

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.

Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization only

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Numeric Pain Rating Scale will be used to measure patient's self perceived pain.

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2020
Last Updated
July 27, 2020
Sponsor
Foundation University Islamabad
Collaborators
Higher Education Commission (Pakistan)
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1. Study Identification

Unique Protocol Identification Number
NCT04299568
Brief Title
Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.
Official Title
Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
Collaborators
Higher Education Commission (Pakistan)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor who will be responsible for collecting the data from the participants in the study will be unaware to the allocation of the participants to the group.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti gravity treadmill training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization only
Intervention Type
Device
Intervention Name(s)
Anti gravity treadmill training
Other Intervention Name(s)
Lower Body Positive Pressure (LBPP) treadmill training
Intervention Description
Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale will be used to measure patient's self perceived pain.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Description
Knee Injury and Osteoarthritis Outcome Score will be used to assess patients symptoms, physical functioning and quality of life.
Time Frame
4 weeks
Title
36-Item Short Form Survey for Quality of Life
Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aamer Naeem, BSPT, PPDPT, MSOMPT, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31403571
Citation
de Heer HD, Kaufman A, Repka CP, Rojas K, Charley B, Bounds R. AlterG Anti-Gravity Treadmill Accuracy of Unloading Is Affected by Support Frame Height. J Strength Cond Res. 2021 Oct 1;35(10):2910-2914. doi: 10.1519/JSC.0000000000003223.
Results Reference
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PubMed Identifier
31380828
Citation
Liang J, Guo Y, Zheng Y, Lang S, Chen H, You Y, O'Young B, Ou H, Lin Q. The Lower Body Positive Pressure Treadmill for Knee Osteoarthritis Rehabilitation. J Vis Exp. 2019 Jul 22;(149). doi: 10.3791/59829.
Results Reference
background
PubMed Identifier
31045790
Citation
Liang J, Lang S, Zheng Y, Wang Y, Chen H, Yang J, Luo Z, Lin Q, Ou H. The effect of anti-gravity treadmill training for knee osteoarthritis rehabilitation on joint pain, gait, and EMG: Case report. Medicine (Baltimore). 2019 May;98(18):e15386. doi: 10.1097/MD.0000000000015386.
Results Reference
background
PubMed Identifier
30277892
Citation
Peeler J, Leiter J, MacDonald P. Effect of Body Weight-Supported Exercise on Symptoms of Knee Osteoarthritis: A Follow-up Investigation. Clin J Sport Med. 2020 Nov;30(6):e178-e185. doi: 10.1097/JSM.0000000000000668.
Results Reference
background
PubMed Identifier
29325839
Citation
Peeler J, Ripat J. The effect of low-load exercise on joint pain, function, and activities of daily living in patients with knee osteoarthritis. Knee. 2018 Jan;25(1):135-145. doi: 10.1016/j.knee.2017.12.003. Epub 2018 Jan 8.
Results Reference
background
PubMed Identifier
27327921
Citation
Bugbee WD, Pulido PA, Goldberg T, D'Lima DD. Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):E167-73.
Results Reference
background
PubMed Identifier
25647537
Citation
Peeler J, Christian M, Cooper J, Leiter J, MacDonald P. Managing Knee Osteoarthritis: The Effects of Body Weight Supported Physical Activity on Joint Pain, Function, and Thigh Muscle Strength. Clin J Sport Med. 2015 Nov;25(6):518-23. doi: 10.1097/JSM.0000000000000173.
Results Reference
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Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.

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