N/A
N=38
Gait Modification Treatments for Knee Pathology
Knee Injuries · Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03116230 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Peak Knee Flexion Moment (%Bw*Ht) — 0.197; 0.018 %Bw*Ht — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cutaneous Stimulation (Device); Knee Sleeve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Knee Flexion Moment (%Bw*Ht) |
0.197; 0.018 | 0.005 sig |
| SECONDARY Change in Pain |
1.476; -0.391 | — |
| SECONDARY Change in Function |
4.48; 0.64 | — |
| SECONDARY Change in Symptoms |
3.571; -0.781 | — |
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. walking, jogging, stair ascending and descending), muscle function, and pain/function.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03116230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.