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Motion Coaching Technology for Physical Therapy in Low Back Pain.

K

Kaia Health Software

Status

Completed

Conditions

Low Back Pain

Treatments

Other: Physiotherapist Exercise Instructions and written handouts
Other: Kaia Back Pain App

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04411108
KaiaMC001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

22 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Exercise Instruction by PT and written handout
Active Comparator group
Treatment:
Other: Physiotherapist Exercise Instructions and written handouts
Exercise Instruction by Motion Coach Technology
Experimental group
Treatment:
Other: Kaia Back Pain App

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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