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OpenTrials
Completed

NCT Number: NCT04411108

Motion Coaching Technology for Physical Therapy in Low Back Pain.

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO

St Louis, Missouri, 63130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Kaia Back Pain App

Other

The Kaia Back Pain App provides instructions on exercise execution to participants for one week

Physiotherapist Exercise Instructions and written handouts

Other

Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week

Primary outcomes

  1. Scoring of each individual exercise rated by a panel of physiotherapists

    Time frame: 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.

Secondary outcomes

  1. Rating of exercise execution concerning specific body regions by physiotherapists

    Time frame: 7 days

    For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3

Sponsors and collaborators

Lead sponsor

Kaia Health Software

Industry

Collaborators

  • Washington University School of Medicine

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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