Osteoarthritis, KneePhase 1/2NCT01397981
Gait Retraining to Reduce Knee Osteoarthritis Pain
A Phase 1/2 study testing Gait retraining in people with Osteoarthritis, Knee, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Gait retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2012
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of medial compartment pain during the previous 6 weeks
- Radiographic evidence (AP X-ray) of medial compartment knee osteoarthritis (KL score of 3 or less)
- Ability to walk unaided for 25 minutes without rest
- Age > 18
Who cannot join
- BMI > 30
- Previous injury or surgery on foot, ankle, knee, hip, or back inhibiting ability to adopt different walking gait
- Use of shoe insert or hinged knee brace
- Corticosteroid injection within the previous 6 weeks
- Age > 80
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Evaluation of Haptic Technologies for Movement Retraining
The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to surgical treatments.
Read the detailed description
During the movement retraining session, you be given different combinations of haptic, visual, and auditory feedback in order to inform you on desired movement changes. This will take place at the Human Performance Laboratory at Stanford University. Motion analysis will be done while you perform movement activities (such as locomotion).
Prior to performing these movement tasks the investigators will attach reflective markers to your body using tape, pre-wrap and/or ace bandages. The investigators will record motion of your body's movements using infrared cameras which capture anatomical data from the reflective markers on your body.
The investigators will provide you with feedback to inform you of desired movement modifications. Haptic feedback devices such as vibration motors and skin stretch devices will be attached to your body via velcro straps and will be used to give "touch" feedback. There will be a computer monitor in front of you during testing to provide visual feedback. Sounds will be played using speakers near the testing area to provide auditory feedback.
The time needed for set up and performance of the above set of tests is approximately 90 minutes. You will be performing walking and other movements for only a small part of that time. The rest of the time will be spent preparing you for the experiment. After the investigators examine your movement data, if some of the data appear inaccurate or the investigators are unable to process the data, the investigators may ask you to repeat the movement analysis at a later time.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Gait retraining
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retrainingBehavioural
Changing the kinematics of walking
| Study group | Role | What they receive |
|---|---|---|
| Walking modification | Experimental | Changing kinematics for walking Receives: Behavioral: Gait retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Knee pain and function
Knee pain and function will be assessed through the standardized KOOS survey
Measured: four weeks
Secondary outcomes (1)
Learning retention, knee adduction moment
Learning retention of gait kinematics and knee joint loading including the knee adduction moment will be measured through motion capture and ground reaction force plates
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pete Bradley Shull, Stanford University
- Investigators
- Pete B Shull, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397981
- Sponsor's protocol ID
- SU-07142011-8086
- Status last verified
- Mar 2013
- First submitted
- 18 Jul 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shull PB, Lurie KL, Cutkosky MR, Besier TF. Training multi-parameter gaits to reduce the knee adduction moment with data-driven models and haptic feedback. J Biomech. 2011 May 17;44(8):1605-9. doi: 10.1016/j.jbiomech.2011.03.016. Epub 2011 Apr 2.
PubMed 21459384Wheeler JW, Shull PB, Besier TF. Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. J Biomech Eng. 2011 Apr;133(4):041007. doi: 10.1115/1.4003621.
PubMed 21428681Shull PB, Shultz R, Silder A, Dragoo JL, Besier TF, Cutkosky MR, Delp SL. Toe-in gait reduces the first peak knee adduction moment in patients with medial compartment knee osteoarthritis. J Biomech. 2013 Jan 4;46(1):122-8. doi: 10.1016/j.jbiomech.2012.10.019. Epub 2012 Nov 10.
PubMed 23146322
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Haptic Technologies for Movement Retraining
- ClinicalTrials.gov ID
- NCT01397981
- Acronym / sponsor ID
- SU-07142011-8086
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- 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.
The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to surgical treatments.
Detailed description
During the movement retraining session, you be given different combinations of haptic, visual, and auditory feedback in order to inform you on desired movement changes. This will take place at the Human Performance Laboratory at Stanford University. Motion analysis will be done while you perform movement activities (such as locomotion).
Prior to performing these movement tasks the investigators will attach reflective markers to your body using tape, pre-wrap and/or ace bandages. The investigators will record motion of your body's movements using infrared cameras which capture anatomical data from the reflective markers on your body.
The investigators will provide you with feedback to inform you of desired movement modifications. Haptic feedback devices such as vibration motors and skin stretch devices will be attached to your body via velcro straps and will be used to give "touch" feedback. There will be a computer monitor in front of you during testing to provide visual feedback. Sounds will be played using speakers near the testing area to provide auditory feedback.
The time needed for set up and performance of the above set of tests is approximately 90 minutes. You will be performing walking and other movements for only a small part of that time. The rest of the time will be spent preparing you for the experiment. After the investigators examine your movement data, if some of the data appear inaccurate or the investigators are unable to process the data, the investigators may ask you to repeat the movement analysis at a later time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking modification | Experimental | Behavioral: Gait retrainingChanging kinematics for walking |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms of medial compartment pain during the previous 6 weeks
- Radiographic evidence (AP X-ray) of medial compartment knee osteoarthritis (KL score of 3 or less)
- Ability to walk unaided for 25 minutes without rest
- Age > 18
Key exclusion criteria (5 listed)
- BMI > 30
- Previous injury or surgery on foot, ankle, knee, hip, or back inhibiting ability to adopt different walking gait
- Use of shoe insert or hinged knee brace
- Corticosteroid injection within the previous 6 weeks
- Age > 80
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 |
|---|---|---|
| Gait retrainingChanging the kinematics of walking | Behavioural | Walking modification |
Primary outcome
Measure: Knee pain and function
Time frame: four weeks
Knee pain and function will be assessed through the standardized KOOS survey
1 secondary outcome
Learning retention, knee adduction moment
Time frame: four 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 6 Mar 2013.
- Background: PubMed 21459384Shull PB, Lurie KL, Cutkosky MR, Besier TF. Training multi-parameter gaits to reduce the knee adduction moment with data-driven models and haptic feedback. J Biomech. 2011 May 17;44(8):1605-9. doi: 10.1016/j.jbiomech.2011.03.016. Epub 2011 Apr 2.
- Background: PubMed 21428681Wheeler JW, Shull PB, Besier TF. Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. J Biomech Eng. 2011 Apr;133(4):041007. doi: 10.1115/1.4003621.
- Results publication: PubMed 23146322Shull PB, Shultz R, Silder A, Dragoo JL, Besier TF, Cutkosky MR, Delp SL. Toe-in gait reduces the first peak knee adduction moment in patients with medial compartment knee osteoarthritis. J Biomech. 2013 Jan 4;46(1):122-8. doi: 10.1016/j.jbiomech.2012.10.019. Epub 2012 Nov 10.
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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.
Pete B Shull study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gait retraining in people with Osteoarthritis, Knee, run by Stanford University at 1 site in United States.
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 4 inclusion and 5 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 6 Mar 2013. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measure: Knee pain and function (time frame: four 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 NCT01397981, which also lists 3 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 6 Mar 2013.