Motion Coaching Technology for Physical Therapy in Low Back Pain.

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411108
• Other study ID #: KaiaMC001
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: August 2022
• Source: Kaia Health Software
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Kaia Back Pain App
The Kaia Back Pain App provides instructions on exercise execution to participants for one week
• Physiotherapist Exercise Instructions and written handouts
Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week

Locations

Country	Name	City	State
United States	Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Kaia Health Software	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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