Chronic Pain of Left Foot (Finding)NCT05009303
Reliability and Validity of the OneStep Smartphone Application for Gait Analysis
An observational study of Chronic Pain of Left Foot (Finding) and Chronic Pain of Right Foot (Finding), run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial summary
Expanding the availability of quantitative tools for gait quality assessment is essential to enable clinicians to analyze patient's gait, monitor gait changes, and modify the rehabilitation process, when gold-standard tools are not available. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain of Left Foot (Finding), Chronic Pain of Right Foot (Finding)
- What is being tested?
- OneStep Smartphone App and C-Mill Treadmill
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2021to 30 Sep 2022
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A sample size of 100 participants (30 healthy individuals and 70 patients) was chosen for the study, which includes men and women, of different age groups, with various lower limb disability levels and functional capacities.
Who may be able to join
- Men and women aged 18 to 65.
- Able to walk independently or with assistance (human / walking aids).
- Able to speak and read in Hebrew fluently.
- Patients requiring lower limb rehabilitation course (inpatient/outpatient) due to lower limb disability or chronic pain
- Ability to successfully complete a routine 6-minute walking test (as part of treatment)
- Mini-Mental State Examination (MMSE) Score ≥ 24
Who cannot join
- Subjects requiring prosthetics or orthoses.
- Subject unable to step on their foot.
- Subject unfit to participate in the study according to the judgment of the principal investigator, including but not limited to:
- 3.1 Known pregnancy. 3.2 Existing cardio-pulmonary disease. 3.3 Balance impairment 3.4 visual disturbances (not rectified by glasses) 3.5 history of falls
- As walking on the treadmill with a walking aid will not be allowed, patients unable to walk without a walking aid will be excluded (use of handrails during walking will be permitted).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Reliability and Validity of the OneStep Smartphone Application for Gait Analysis During Treadmill Walking
Expanding the availability of quantitative tools for gait quality assessment is essential to enable clinicians to analyze patient's gait, monitor gait changes, and modify the rehabilitation process, when gold-standard tools are not available. The OneStep technology is a smartphone application (app), that uses smartphone sensors to provide ongoing gait diagnostics. This study aims to further evaluate the analytical capability of the OneStep algorithm in recording and analyzing gait parameters and test its reliability and validity. The study will take place at Reuth Rehabilitation Hospital. All participants will be using the App and the C-Mill treadmill (Motek, Amsterdam, Netherlands) built-in gait analysis system, during two separate treadmill walks of up to 15 minutes. All walking sessions will be recorded with two cameras. Data obtained from participants will be collected and analyzed for gait parameters. The study sample will include 30 healthy volunteers and 70 patients.
Read the detailed description
Background:
The current gold standard for gait analyses are laboratories equipped for three-dimensional gait analysis. However, a major drawback of these laboratories is their inability to examine gait in patients' own environment. Therefore, there is a need for an inexpensive, portable, easy-to-use, and reliable gait tracking method. Wearable devices and smartphones may provide a solution. The OneStep smartphone application (app) is one such technology. It can be downloaded to a smartphone, placed in the pants pocket, and once activated, can collect gait data while a subject is in motion. In an earlier study, the OneStep app has been used to collect data on patients with lower extremity disability or pain, during in-hospital physiotherapy sessions, self-exercises in the hospital or at home, and other daily activities, to assess patients' adherence to and compliance with the prescribed rehabilitation regimen.
Study Objectives:
The goal of this study is to expand the utilization of the OneStep app in gait parameters analysis by:
- Collecting and analyzing new walking parameters: main parts of the foot bearing weight; walking base; identification of which part hits the ground first during the initial contact; ankle and knee range of motion; pelvic movement
- Validating the OneStep app against standard gait measurement tools among both healthy volunteers and patients
- Assessing the test-retest reliability of the OneStep app gait measurements.
Method:
The study sample will include a total of 100 participants: 30 healthy volunteers and 70 patients. Each participant will have two sessions using the treadmill for walks of up to 15 minutes, with the second walking session used for test-retest reliability assessment. Healthy volunteers will complete the second session on the same day as the first session after a 10-minute break. Patients will complete the second session within one week of the first. A check-in phase will be performed at the beginning of each session, during which the participants (specifically the patients) will be instructed to rest for up to 10 min, to ensure their performance on treadmill is not affected by prior physical activities.
During both sessions, participants will use the C-Mill treadmill (Motek, Amsterdam, Netherlands) and will be equipped with 2 smartphones placed on each hip. As some patients will not be able to keep on walking for 15 minutes, a minimal duration of the required walk was set at 2 minutes. Sessions will be recorded using two high resolution video cameras. The phones will be placed in a participant's front pants pockets; for those without pockets, two leg harnesses will be provided with space to hold the phones.
Data obtained from all participants will be collected and analyzed for gait parameters. Patients were instructed to walk at a comfortable gait speed. Healthy volunteers were given a specific walking protocol of 15 minutes each, which consisted of 14 selected gait types with different speeds and walking styles.
- Being tested
- OneStep Smartphone App and C-Mill Treadmill
- Keywords
- gait analysis, chronic pain, smartphone app, rehabilitation, validation, test-retest reliability
- Medical subject headings
- Signs and Symptoms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneStep Smartphone App and C-Mill TreadmillDevice
OneStep technology is a smartphone application that utilizes smartphone sensors to provide ongoing gait diagnostics. Each participant will have two sessions, during which, they will walk on a C-Mill smart treadmill for up to 15 minutes (with a minimum of 2 minutes), while carrying 2 smartphones and being recorded via two video cameras. The second walking session, conducted under similar conditions, will be used for test-retest reliability.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Thirty healthy individuals and seventy patients suffering from chronic pain or disability in one or both of their lower extremities Receives: Device: OneStep Smartphone App and C-Mill Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
Number of steps per minute [in steps per minute]
Measured: A walking session of up to 15 minutes
Gait Speed
Time one takes to walk a specified distance [Expressed as ratio between distance and time, in meters per second]
Measured: A walking session of up to 15 minutes
Stride Length
Distance [in cm] covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel)
Measured: A walking session of up to 15 minutes
Step Length
The distance [in cm] between the heel strike of one foot and the heel strike of the opposite foot (measured separately for each foot)
Measured: A walking session of up to 15 minutes
Swing Phase Duration
The swing phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. [Expressed in seconds or as percentage of the gait cycle] (measured separately for each foot)
Measured: A walking session of up to 15 minutes
Stance Phase Duration
The stance phase of gait begins when the foot first touches the ground and ends when the same foot leaves the ground. [Expressed in seconds or as percentage of the gait cycle] (measured separately for each foot)
Measured: A walking session of up to 15 minutes
Single Limb Support Duration
Part of the swing phase where only one limb in in contact with the ground [Expressed in seconds or as percentage of the stance phase] (measured separately for each foot)
Measured: A walking session of up to 15 minutes
Double Limb Support Duration
Part of the swing phase where both limbs are in contact with the ground [Expressed in seconds or as percentage of the stance phase]
Measured: A walking session of up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 May 2021
- Primary completion1 Mar 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain of Left Foot (Finding)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Gefen-Doron, MD, Principal investigator, Reuth Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009303
- Sponsor's protocol ID
- 0003-21-RRH
- Status last verified
- May 2022
- First submitted
- 29 Jul 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reliability and Validity of the OneStep Smartphone Application for Gait Analysis During Treadmill Walking
- ClinicalTrials.gov ID
- NCT05009303
- Acronym / sponsor ID
- 0003-21-RRH
- Keywords
- gait analysis, chronic pain, smartphone app, rehabilitation, validation, test-retest reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 17 Aug 2021 (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.
Expanding the availability of quantitative tools for gait quality assessment is essential to enable clinicians to analyze patient's gait, monitor gait changes, and modify the rehabilitation process, when gold-standard tools are not available. The OneStep technology is a smartphone application (app), that uses smartphone sensors to provide ongoing gait diagnostics. This study aims to further evaluate the analytical capability of the OneStep algorithm in recording and analyzing gait parameters and test its reliability and validity. The study will take place at Reuth Rehabilitation Hospital. All participants will be using the App and the C-Mill treadmill (Motek, Amsterdam, Netherlands) built-in gait analysis system, during two separate treadmill walks of up to 15 minutes. All walking sessions will be recorded with two cameras. Data obtained from participants will be collected and analyzed for gait parameters. The study sample will include 30 healthy volunteers and 70 patients.
Detailed description
Background:
The current gold standard for gait analyses are laboratories equipped for three-dimensional gait analysis. However, a major drawback of these laboratories is their inability to examine gait in patients' own environment. Therefore, there is a need for an inexpensive, portable, easy-to-use, and reliable gait tracking method. Wearable devices and smartphones may provide a solution. The OneStep smartphone application (app) is one such technology. It can be downloaded to a smartphone, placed in the pants pocket, and once activated, can collect gait data while a subject is in motion. In an earlier study, the OneStep app has been used to collect data on patients with lower extremity disability or pain, during in-hospital physiotherapy sessions, self-exercises in the hospital or at home, and other daily activities, to assess patients' adherence to and compliance with the prescribed rehabilitation regimen.
Study Objectives:
The goal of this study is to expand the utilization of the OneStep app in gait parameters analysis by:
- Collecting and analyzing new walking parameters: main parts of the foot bearing weight; walking base; identification of which part hits the ground first during the initial contact; ankle and knee range of motion; pelvic movement
- Validating the OneStep app against standard gait measurement tools among both healthy volunteers and patients
- Assessing the test-retest reliability of the OneStep app gait measurements.
Method:
The study sample will include a total of 100 participants: 30 healthy volunteers and 70 patients. Each participant will have two sessions using the treadmill for walks of up to 15 minutes, with the second walking session used for test-retest reliability assessment. Healthy volunteers will complete the second session on the same day as the first session after a 10-minute break. Patients will complete the second session within one week of the first. A check-in phase will be performed at the beginning of each session, during which the participants (specifically the patients) will be instructed to rest for up to 10 min, to ensure their performance on treadmill is not affected by prior physical activities.
During both sessions, participants will use the C-Mill treadmill (Motek, Amsterdam, Netherlands) and will be equipped with 2 smartphones placed on each hip. As some patients will not be able to keep on walking for 15 minutes, a minimal duration of the required walk was set at 2 minutes. Sessions will be recorded using two high resolution video cameras. The phones will be placed in a participant's front pants pockets; for those without pockets, two leg harnesses will be provided with space to hold the phones.
Data obtained from all participants will be collected and analyzed for gait parameters. Patients were instructed to walk at a comfortable gait speed. Healthy volunteers were given a specific walking protocol of 15 minutes each, which consisted of 14 selected gait types with different speeds and walking styles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: OneStep Smartphone App and C-Mill TreadmillThirty healthy individuals and seventy patients suffering from chronic pain or disability in one or both of their lower extremities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A sample size of 100 participants (30 healthy individuals and 70 patients) was chosen for the study, which includes men and women, of different age groups, with various lower limb disability levels and functional capacities.
Key inclusion criteria (6 listed)
- Men and women aged 18 to 65.
- Able to walk independently or with assistance (human / walking aids).
- Able to speak and read in Hebrew fluently.
- Patients requiring lower limb rehabilitation course (inpatient/outpatient) due to lower limb disability or chronic pain
- Ability to successfully complete a routine 6-minute walking test (as part of treatment)
Key exclusion criteria (5 listed)
- Subjects requiring prosthetics or orthoses.
- Subject unable to step on their foot.
- Subject unfit to participate in the study according to the judgment of the principal investigator, including but not limited to:
- 3.1 Known pregnancy. 3.2 Existing cardio-pulmonary disease. 3.3 Balance impairment 3.4 visual disturbances (not rectified by glasses) 3.5 history of falls
- As walking on the treadmill with a walking aid will not be allowed, patients unable to walk without a walking aid will be excluded (use of handrails during walking will be permitted).
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 |
|---|---|---|
| OneStep Smartphone App and C-Mill TreadmillOneStep technology is a smartphone application that utilizes smartphone sensors to provide ongoing gait diagnostics. Each participant will have two sessions, during which, they will walk on a C-Mill smart treadmill for up to 15 minutes (with a minimum of 2 minutes), while carrying 2 smartphones and being recorded via two video cameras. The second walking session, conducted under similar conditions, will be used for test-retest reliability. | Device | Participants |
Primary outcome
Cadence
Time frame: A walking session of up to 15 minutes
Number of steps per minute [in steps per minute]
Gait Speed
Time frame: A walking session of up to 15 minutes
Time one takes to walk a specified distance [Expressed as ratio between distance and time, in meters per second]
Stride Length
Time frame: A walking session of up to 15 minutes
Distance [in cm] covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel)
Step Length
Time frame: A walking session of up to 15 minutes
The distance [in cm] between the heel strike of one foot and the heel strike of the opposite foot (measured separately for each foot)
Swing Phase Duration
Time frame: A walking session of up to 15 minutes
The swing phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. [Expressed in seconds or as percentage of the gait cycle] (measured separately for each foot)
Stance Phase Duration
Time frame: A walking session of up to 15 minutes
The stance phase of gait begins when the foot first touches the ground and ends when the same foot leaves the ground. [Expressed in seconds or as percentage of the gait cycle] (measured separately for each foot)
Single Limb Support Duration
Time frame: A walking session of up to 15 minutes
Part of the swing phase where only one limb in in contact with the ground [Expressed in seconds or as percentage of the stance phase] (measured separately for each foot)
Double Limb Support Duration
Time frame: A walking session of up to 15 minutes
Part of the swing phase where both limbs are in contact with the ground [Expressed in seconds or as percentage of the stance phase]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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.
Dana Gefen-Doron, MD principal investigator
Reuth Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain of Left Foot (Finding) and Chronic Pain of Right Foot (Finding), run by Reuth Rehabilitation Hospital at 1 site in Israel.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 May 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 Israel. 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?
Results are not available in the source record.
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?
Cadence (time frame: A walking session of up to 15 minutes). The study lists 8 primary outcomes in all. 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 18 May 2022.