Osteo Arthritis KneeNCT04299568
Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.
A study testing Anti gravity treadmill training and Physical Therapy in people with Osteo Arthritis Knee, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Anti gravity treadmill training and Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2020to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female
- Age group 50-75 years
- Knee osteoarthritis GI, GII and G III (Kellgren \& Lawrence system).
Who cannot join
- Traumatic arthritis
- Unstable cardiovascular state
- Neuro-muscular disorders involving the lower extremity
- History of surgery of lower limb
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
About this study
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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Anti gravity treadmill training, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti gravity treadmill trainingDevice
Also called Lower Body Positive Pressure (LBPP) treadmill training
Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes
Physical TherapyProcedure or surgery
Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Anti gravity treadmill training; Procedure: 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 Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale will be used to measure patient's self perceived pain.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
36-Item Short Form Survey for Quality of Life
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Feb 2020
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Higher Education Commission (Pakistan)
- Responsible party
- Sponsor
- Investigators
- Aamer Naeem, BSPT, PPDPT, MSOMPT, PhD*, Principal investigator, Foundation University IslamabadMuhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299568
- Sponsor's protocol ID
- FUI/CTR/2020/1
- Status last verified
- Jul 2020
- First submitted
- 5 Mar 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31403571Liang 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.
PubMed 31380828Liang 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.
PubMed 31045790Peeler 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.
PubMed 30277892Peeler 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.
PubMed 29325839Bugbee 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.
PubMed 27327921Peeler 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.
PubMed 25647537
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-gravity Treadmill Training on Knee Osteoarthritis in Geriatric Population.
- ClinicalTrials.gov ID
- NCT04299568
- Acronym / sponsor ID
- FUI/CTR/2020/1
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Collaborators
- Higher Education Commission (Pakistan)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti gravity treadmill training | Experimental | Device: Anti gravity treadmill training, Procedure: Physical TherapyHeat 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. |
| Control | Active comparator | Procedure: Physical TherapyHeat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization only |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female
- Age group 50-75 years
- Knee osteoarthritis GI, GII and G III (Kellgren \& Lawrence system).
Key exclusion criteria (4 listed)
- Traumatic arthritis
- Unstable cardiovascular state
- Neuro-muscular disorders involving the lower extremity
- History of surgery of lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti gravity treadmill trainingAlso: Lower Body Positive Pressure (LBPP) treadmill trainingLower Body Positive Pressure (LBPP) treadmill training for 15 minutes | Device | Anti gravity treadmill training |
| Physical TherapyHeat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization | Procedure or surgery | Anti gravity treadmill training, Control |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
Numeric Pain Rating Scale will be used to measure patient's self perceived pain.
2 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 4 weeks
36-Item Short Form Survey for Quality of Life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 31403571de 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.
- Background: PubMed 31380828Liang 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.
- Background: PubMed 31045790Liang 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.
- Background: PubMed 30277892Peeler 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.
- Background: PubMed 29325839Peeler 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.
- Background: PubMed 27327921Bugbee 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.
- Background: PubMed 25647537Peeler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aamer Naeem, BSPT, PPDPT, MSOMPT, PhD* principal investigator
Foundation University Islamabad
Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD* principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti gravity treadmill training and Physical Therapy in people with Osteo Arthritis Knee, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299568, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.