Motion Coaching Technology for Physical Therapy in Low Back Pain.

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Physiotherapist Exercise Instructions and written handouts; Other: Kaia Back Pain App

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise Instruction by PT and written handout	Other: Physiotherapist Exercise Instructions and written handouts; Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
Experimental: Exercise Instruction by Motion Coach Technology	Other: Kaia Back Pain App; The Kaia Back Pain App provides instructions on exercise execution to participants for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoring of each individual exercise rated by a panel of physiotherapists	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.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaia Health Software
• Collaborators: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KaiaMC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No