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Motion Coaching Technology for Physical Therapy in Low Back Pain.

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kaia Back Pain App
Physiotherapist Exercise Instructions and written handouts
Sponsored by
Kaia Health Software
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise Instruction by PT and written handout

Exercise Instruction by Motion Coach Technology

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2020
Last Updated
August 9, 2022
Sponsor
Kaia Health Software
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04411108
Brief Title
Motion Coaching Technology for Physical Therapy in Low Back Pain.
Official Title
Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaia Health Software
Collaborators
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Instruction by PT and written handout
Arm Type
Active Comparator
Arm Title
Exercise Instruction by Motion Coach Technology
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Kaia Back Pain App
Intervention Description
The Kaia Back Pain App provides instructions on exercise execution to participants for one week
Intervention Type
Other
Intervention Name(s)
Physiotherapist Exercise Instructions and written handouts
Intervention Description
Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
Primary Outcome Measure Information:
Title
Scoring of each individual exercise rated by a panel of physiotherapists
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Rating of exercise execution concerning specific body regions by physiotherapists
Description
For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Motion Coaching Technology for Physical Therapy in Low Back Pain.

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