Low Back PainNCT04411108
Motion Coaching Technology for Physical Therapy in Low Back Pain.
A study testing Kaia Back Pain App and Physiotherapist Exercise Instructions and written handouts in people with Low Back Pain, run by Kaia Health Software at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Kaia Back Pain App and Physiotherapist Exercise Instructions and written handouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Department of Orthopaedic Surgery, Division of Spine Surgery, Washington University in St. Louis, MO
St Louis, Missouri, 63130
About this study
Official title: Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.
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
- Being tested
- Kaia Back Pain App, Physiotherapist Exercise Instructions and written handouts
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaia Back Pain AppOther
The Kaia Back Pain App provides instructions on exercise execution to participants for one week
Physiotherapist Exercise Instructions and written handoutsOther
Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
| Study group | Role | What they receive |
|---|---|---|
| Exercise Instruction by PT and written handout | Active comparator | Not described Receives: Other: Physiotherapist Exercise Instructions and written handouts |
| Exercise Instruction by Motion Coach Technology | Experimental | Not described Receives: Other: Kaia Back Pain App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
Rating of exercise execution concerning specific body regions by physiotherapists
For predefined segments for every exercise, a panel of physiotherapists scores execution quality on a scale of 0-3
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start20 Oct 2020
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaia Health Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411108
- Sponsor's protocol ID
- KaiaMC001
- Status last verified
- Aug 2022
- First submitted
- 14 May 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Motion Coaching Technology for Physical Therapy in Treating Patients With Chronic, Nonspecific Low Back Pain. A Pilot Project.
- ClinicalTrials.gov ID
- NCT04411108
- Acronym / sponsor ID
- KaiaMC001
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kaia Health SoftwareIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaia Back Pain AppThe Kaia Back Pain App provides instructions on exercise execution to participants for one week | Other | Exercise Instruction by Motion Coach Technology |
| Physiotherapist Exercise Instructions and written handoutsParticipants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week | Other | Exercise Instruction by PT and written handout |
Primary outcome
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.
1 secondary outcome
Rating of exercise execution concerning specific body regions by physiotherapists
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaia Back Pain App and Physiotherapist Exercise Instructions and written handouts in people with Low Back Pain, run by Kaia Health Software at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring of each individual exercise rated by a panel of physiotherapists (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.