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Motion Coaching Technology for Physical Therapy in Low Back Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411108
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : August 12, 2022
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Kaia Health Software

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Kaia Back Pain App Other: Physiotherapist Exercise Instructions and written handouts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.
Actual Study Start Date : October 20, 2020
Actual Primary Completion Date : September 27, 2021
Actual Study Completion Date : September 27, 2021


Arm Intervention/treatment
Active Comparator: Exercise Instruction by PT and written handout Other: Physiotherapist Exercise Instructions and written handouts
Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week

Experimental: Exercise Instruction by Motion Coach Technology Other: Kaia Back Pain App
The Kaia Back Pain App provides instructions on exercise execution to participants for one week




Primary Outcome Measures :
  1. Scoring of each individual exercise rated by a panel of physiotherapists [ Time Frame: 7 days ]
    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.


Secondary Outcome Measures :
  1. Rating of exercise execution concerning specific body regions by physiotherapists [ Time Frame: 7 days ]
    For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411108


Locations
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United States, Missouri
Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO
Saint Louis, Missouri, United States, 63130
Sponsors and Collaborators
Kaia Health Software
Washington University School of Medicine
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Responsible Party: Kaia Health Software
ClinicalTrials.gov Identifier: NCT04411108    
Other Study ID Numbers: KaiaMC001
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations