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临床试验/NCT04411108
NCT04411108已完成不适用

Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.

Kaia Health Software1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Scoring of each individual exercise rated by a panel of physiotherapists

研究概览

简要总结

In this study, we will compare exercise execution between two groups of patients: (1) individuals who undergo instruction session by a PT and then perform exercises with a written handout at home and (2) individuals who use the mHealth motion coach at home. Participants will perform the same 4 exercises. Both groups will be instructed to exercise at home, supported either by the handouts or the Motion Coach technology and then return after 1 week for assessment.

For the assessment, standardized videos will be used to capture pose during exercise execution. Group 1 will perform the exercises with the written handout; group 2 will perform the exercises with the motion coach. Rating will be performed by a panel of PT professionals on the overall assessment of each exercises and on the three segments mentioned below that are exercise specific. The first group with PT instruction and written handout portion will be compared to the second group with the motion coach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 22 - 65
  • •English speaking
  • •Absence of neurologic deficits as assessed by the clinician, with 5/5 strength in all muscle groups in the lower extremities and no sensory deficits in the lower extremities
  • •Pain located in the low back or posterior pelvic region
  • •Self-reported mean pain score >4 in the past 1 week as assessed by VAS pain score from 0-10
  • •Pain duration >1 month to 5 years
  • •Ambulatory w/out assist prior to enrollment

排除标准

  • •Red flag signs including fevers, unexplained weight loss, personal history of cancer, tuberculosis exposure, history of spinal infection, history of thoracolumbar spine fracture in the past year as assessed by the clinician.
  • •Use of assistive ambulatory device
  • •Pregnancy
  • •Formal physical therapy within the past 6 months
  • •Neurologic symptoms including weakness or sensory changes in the bilateral lower extremities as assessed by the clinician.
  • •Pain radiating below the posterior pelvic region into either lower extremity
  • •Unwilling or unable to commit to study procedures
  • •Physically incapable of completing PT exercises safely as determined by clinician

研究组 & 干预措施

Exercise Instruction by PT and written handout

Active Comparator

干预措施: Physiotherapist Exercise Instructions and written handouts (Other)

Exercise Instruction by Motion Coach Technology

Experimental

干预措施: Kaia Back Pain App (Other)

结局指标

主要结局

Scoring of each individual exercise rated by a panel of physiotherapists

时间窗: 7 days

A panel of 5 physiotherapists each rates every repetition recorded as acceptable or not. If greater than 90% are rated as acceptable, the exercise will be assessed as acceptable.

次要结局

  • Rating of exercise execution concerning specific body regions by physiotherapists(7 days)

研究者

发起方
Kaia Health Software
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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