Osteoarthritis, KneeNCT02884414
Gait Modifications and Cutaneous Stimulation
A study testing Cutaneous stimulation in people with Osteoarthritis, Knee, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cutaneous stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 35 kg/m^2
- For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain
- Full weight-bearing status
Who cannot join
- Non-ambulatory
- Use of walking aid
- For healthy volunteers - history of surgical intervention at any joint of the lower extremity
- Inability to cooperate with study protocol due to medical or psychiatric reasons
- Inability to provide informed consent
- For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation
The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cutaneous stimulation
- Keywords
- Knee Pathology
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous stimulationDevice
A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous Stimulation | Experimental | Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external. Receives: Device: Cutaneous stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Knee Flexion Moment (%Bw*Ht)
Within-subject change in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention).
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Peter Andriacchi, Stanford University
- Investigators
- Thomas Andriacchi, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884414
- Sponsor's protocol ID
- 37562
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2016
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation
- ClinicalTrials.gov ID
- NCT02884414
- Acronym / sponsor ID
- 37562
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 8 Jan 2021
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 quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutaneous Stimulation | Experimental | Device: Cutaneous stimulationCutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI < 35 kg/m^2
- For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain
- Full weight-bearing status
Key exclusion criteria (6 listed)
- Non-ambulatory
- Use of walking aid
- For healthy volunteers - history of surgical intervention at any joint of the lower extremity
- Inability to cooperate with study protocol due to medical or psychiatric reasons
- Inability to provide informed consent
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 |
|---|---|---|
| Cutaneous stimulationA non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject. | Device | Cutaneous Stimulation |
Primary outcome
Change in Peak Knee Flexion Moment (%Bw*Ht)
Time frame: Immediate
Within-subject change in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Thomas Andriacchi, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutaneous stimulation 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 3 inclusion and 6 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 8 Jan 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Peak Knee Flexion Moment (%Bw*Ht) (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2021.