Motion Coaching Technology for Physical Therapy in Low Back Pain.

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Kaia Back Pain App; Other: Physiotherapist Exercise Instructions and written handouts

• Registration Number: NCT04411108
• Lead Sponsor: Kaia Health Software

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-02
• Study Start: 2020-10-20
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Instruction by Motion Coach Technology	Kaia Back Pain App	-
Exercise Instruction by PT and written handout	Physiotherapist Exercise Instructions and written handouts	-

Primary Outcome Measures

Name	Time	Method
Scoring of each individual exercise rated by a panel of physiotherapists	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 Outcome Measures

Name	Time	Method
Rating of exercise execution concerning specific body regions by physiotherapists	7 days	For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO; 🇺🇸 Saint Louis, Missouri, United States