NCT04299568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

March 5, 2020

Last Update Submit

July 27, 2020

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale

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

    4 weeks

Secondary Outcomes (2)

  • Knee Injury and Osteoarthritis Outcome Score

    4 weeks

  • 36-Item Short Form Survey for Quality of Life

    4 weeks

Study Arms (2)

Anti gravity treadmill training

EXPERIMENTAL

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 trainingProcedure: Physical Therapy

Control

ACTIVE COMPARATOR

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

Procedure: Physical Therapy

Interventions

Anti gravity treadmill trainingDEVICE

Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes

Also known as: Lower Body Positive Pressure (LBPP) treadmill training
Anti gravity treadmill training
Physical TherapyPROCEDURE

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

Anti gravity treadmill trainingControl

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, 46000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 31403571BACKGROUND

  • 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.

    PMID: 31380828BACKGROUND

  • 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.

    PMID: 31045790BACKGROUND

  • 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.

    PMID: 30277892BACKGROUND

  • 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.

    PMID: 29325839BACKGROUND

  • 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.

    PMID: 27327921BACKGROUND

  • 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.

    PMID: 25647537BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Aamer Naeem, BSPT, PPDPT, MSOMPT, PhD*

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

  • Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 6, 2020

Study Start

February 28, 2020

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)