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临床试验/NCT03116230
NCT03116230已完成不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Change in Peak Knee Flexion Moment (%Bw*Ht)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be told only that we are comparing two types of treatment for their knee pain.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Pain(Baseline and 4 week follow-up)
  • Change in Function(Baseline and 4 week follow-up)
  • Change in Symptoms(Baseline and 4-week follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Peter Andriacchi

Principal Investigator

Stanford University

研究点 (2)

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