Motion Coaching Technology for Physical Therapy in Low Back Pain.

NCT ID: NCT04411108

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2021-09-27

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Instruction by PT and written handout

Group Type: ACTIVE_COMPARATOR

Physiotherapist Exercise Instructions and written handouts

Intervention Type: OTHER

Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week

Exercise Instruction by Motion Coach Technology

Group Type: EXPERIMENTAL

Kaia Back Pain App

Intervention Type: OTHER

The Kaia Back Pain App provides instructions on exercise execution to participants for one week

Interventions

Kaia Back Pain App

The Kaia Back Pain App provides instructions on exercise execution to participants for one week

Intervention Type: OTHER

Physiotherapist Exercise Instructions and written handouts

Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week

Intervention Type: OTHER

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Kaia Health Software

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

St Louis, Missouri, United States

Countries

United States

Other Identifiers

KaiaMC001

Identifier Type: -

Identifier Source: org_study_id