Clinical trial NCT04411108: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Kaia Health Software
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
First posted: 2020-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Scoring of each individual exercise rated by a panel of physiotherapists
timeFrame: 7 days
Secondary outcomes:
measure: Rating of exercise execution concerning specific body regions by physiotherapists
timeFrame: 7 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO
state: Missouri
Study officials:
References: