Knee InjuriesNCT03116230

Gait Modification Treatments for Knee Pathology

A study testing Cutaneous Stimulation and Knee Sleeve in people with Knee Injuries and Knee Osteoarthritis, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Knee Injuries, Knee Osteoarthritis
What is being tested?: Cutaneous Stimulation and Knee Sleeve
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2018to 22 Jan 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80
Ambulatory
Symptomatic knee pain ≥ 3/10 on most of the past 30 days
Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.

Who cannot join

Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
BMI ≥ 35 kg/m2
Injection in the affected knee during the previous three months
Known neuropathy due to diabetes or other causes
Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology

Conditions: Knee Injuries, Knee Osteoarthritis
Being tested: Cutaneous Stimulation, Knee Sleeve
Keywords: Knee pathology
Medical subject headings: Knee Injuries, 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.
Knee SleeveDevice
Commercially-available knee sleeve.

Study groups in NCT03116230
Study group	Role	What they receive
Experimental Treatment A then B	Experimental	Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period. Receives: Device: Cutaneous Stimulation; Device: Knee Sleeve
Experimental Treatment B then A	Experimental	Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject, separated by a washout period. Receives: Device: Cutaneous Stimulation; Device: Knee Sleeve

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 (follow-up - baseline) in peak knee flexion moment (%Bodyweight*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.
Measured: Baseline and 4 week follow-up

Secondary outcomes (3)

Change in Pain
Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline and 4 week follow-up
Change in Function
Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline and 4 week follow-up
Change in Symptoms
Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline and 4-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201822 Jan 2019

First posted17 Apr 2017
Study start15 Jan 2018
Primary completion22 Jan 2019
Study completion22 Jan 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 Knee InjuriesStudies 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03116230
Sponsor's protocol ID: 40688
Status last verified: Jul 2021
First submitted: 11 Apr 2017
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
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Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis

All Knee Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology
ClinicalTrials.gov ID: NCT03116230
Acronym / sponsor ID: 40688
Conditions: Knee Injuries, Knee Osteoarthritis
Keywords: Knee pathology
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 15 Jan 2018 (actual)
Primary completion: 22 Jan 2019 (actual)
Study completion: 22 Jan 2019 (actual)
First posted: 17 Apr 2017 (actual)
Results: Posted 17 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental Treatment A then B	Experimental	Device: Cutaneous Stimulation, Device: Knee SleeveSubjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period.
Experimental Treatment B then A	Experimental	Device: Cutaneous Stimulation, Device: Knee SleeveSubjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject, separated by a washout period.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18-80
Ambulatory
Symptomatic knee pain ≥ 3/10 on most of the past 30 days
Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)

Key exclusion criteria (5 listed)

Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
BMI ≥ 35 kg/m2
Injection in the affected knee during the previous three months
Known neuropathy due to diabetes or other causes
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	Experimental Treatment A then B, Experimental Treatment B then A
Knee SleeveCommercially-available knee sleeve.	Device	Experimental Treatment A then B, Experimental Treatment B then A

Primary outcome

Change in Peak Knee Flexion Moment (%Bw*Ht)
Time frame: Baseline and 4 week follow-up
Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.

3 secondary outcomes

Change in Pain
Time frame: Baseline and 4 week follow-up
Change in Function
Time frame: Baseline and 4 week follow-up
Change in Symptoms
Time frame: Baseline and 4-week follow-up

Results and safety

Results posted to the registry on 17 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Treatment A Then B	19	15
Experimental Treatment B Then A	19	17

Primary outcome: Change in Peak Knee Flexion Moment (%Bw*Ht)

Time frame: Baseline and 4 week follow-up. Mean (Standard Deviation). Unit: %Bw*Ht

Measure	Treatment A (Cutaneous Stimulation) n = 32	Treatment B (Knee Sleeve) n = 32
Value	0.197 (0.374)	0.018 (0.725)

Treatment A (Cutaneous Stimulation): p = 0.005, t-test, 2 sided
Treatment B (Knee Sleeve): p = 0.64, t-test, 2 sided

Population analysed: Participants completing the study protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During active study participation, up to 4 weeks for each treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A (Cutaneous Stimulation)	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32
Treatment B (Knee Sleeve)	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Knee Injuries

Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
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RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis

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 and Knee Sleeve in people with Knee Injuries and Knee Osteoarthritis, 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 6 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 17 Aug 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 17 Aug 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: Baseline and 4 week follow-up). 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 NCT03116230.

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 17 Aug 2021.