Motion Coaching Technology for Physical Therapy in Low Back Pain.

NCT04411108 | Completed

• 1 other identifier: KaiaMC001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rating of exercise execution concerning specific body regions by physiotherapists

  7 days

Study Arms (2)

Exercise Instruction by PT and written handout

ACTIVE COMPARATOR

Other: Physiotherapist Exercise Instructions and written handouts

Exercise Instruction by Motion Coach Technology

EXPERIMENTAL

Other: Kaia Back Pain App

Interventions

Kaia Back Pain App OTHER

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

Exercise Instruction by Motion Coach Technology

Physiotherapist Exercise Instructions and written handouts OTHER

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

Exercise Instruction by PT and written handout

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaia Health Software: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

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

St Louis, Missouri, 63130, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 2, 2020
• Study Start: October 20, 2020
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)