Chronic Pain of Left Foot (Finding)NCT05012891
Gait Analysis Using OneStep Smartphone Application
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
OneStep technology is a smartphone application, utilizing smartphone sensors to provide ongoing gait diagnostics. In this longitudinal study, 50 consecutive patients with lower-extremity disability or chronic pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain of Left Foot (Finding), Chronic Pain of Right Foot (Finding)
- What is being tested?
- OneStep Smartphone Application
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2020to 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a lower-extremity disability or chronic pain (unilateral or bilateral). (Chronic pain was defined as pain lasting more than 3 months)
Who may be able to join
- Men and women aged 18 to 65 years old.
- Able to walk independently or with assistance (human/walking aids).
- Able to speak and read fluently in Hebrew.
- Admitted for rehabilitation at a rehabilitation hospital day-care center following lower-extremity disability or chronic pain (unilateral or bilateral).
- Have undergone at least 4 weeks of rehabilitation, but require an additional (at least one month long) rehabilitation course.
- Subjects must be willing to use their own smartphone device to install the OneStep application for study procedures and to comply with the study protocol.
- The subjects' smartphone has to be compatible with the OneStep app hardware requirements.
Who cannot join
- Subject unable to step on the sore foot.
- Subject unfit to participate in the study based on the judgment of the study principal investigator.
- Subjects who are permanently wheelchair-bound.
- Subjects with known pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Analysis in Patients Undergoing Rehabilitation Due to Lower Extremity Disability or Chronic Pain, Using OneStep Smartphone Application.
OneStep technology is a smartphone application, utilizing smartphone sensors to provide ongoing gait diagnostics. In this longitudinal study, 50 consecutive patients with lower-extremity disability or chronic pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual rehabilitation treatments, during a one-month period. Analyzed gait data from the App will be linked with clinical data collected by a team of experts, in order to evaluate the potential use of this App as an objective means to characterize and quantify patients' gait characteristics along the follow-up period, and to objectively assess the patients' adherence and compliance with the rehabilitation regime.
Read the detailed description
Background:
Patient adherence is a crucial determinant of the rehabilitation process. After injury or surgery, many patients are given specific exercises to conduct unsupervised on their own to aid their recovery. Evidence suggests that noncompliance with the prescribed exercise regime is associated with poor rehabilitation outcomes. OneStep technology is a smartphone application (App), which uses smartphone sensors to provide ongoing gait diagnostics.
Study Objectives:
- To analyze gait-related parameters collected via the OneStep App in patients with lower extremity disability or chronic pain over a 4-week follow-up period during in-hospital physiotherapy sessions, self-exercises at home, and other daily activities,
- To objectively assess the patients' adherence and compliance with the prescribed rehabilitation regime. For the purposes of this research, adherence refers to the quantity and frequency of completed home exercises, while compliance refers to the quality of meeting the physiotherapists' walking-related recommendations.
- To assess gait parameters measured simultaneously on both feet, during standard walking-related tests, (performed under similar conditions on days 1, 14, 28, while using the OneStep App), for between and within-subject comparison.
- To compare between patients' subjective self-reports on performed physiotherapy workouts at home, the physiotherapists' own subjective assessments on their patients' adherence and compliance, and the objective data collected using the OneStep App
Methods:
Fifty consecutive patients with lower-extremity disability or pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual rehabilitation treatments, during a one-month period. The study participants will be asked to carry the smartphone with the preinstalled app on them at all times, specifically on their injured foot.
All participants will also be required to undertake standard walking tests at the study initiation day (day 1) and on days 14 and 28 under similar conditions for between and within-subject comparison. Only during these tests will the subjects be using two smartphones preinstalled with the OneStep App, one attached to each leg, for a more accurate gait symmetry assessment.
During these 3 sessions, the study participants, as well as their physiotherapists, will be asked to fill in the study questionnaires.
Hypothesis:
Data collected using the OneStep App will allow an accurate and informative follow-up on patients' adherence and compliance with the rehabilitation regime and assist the physiotherapists in improving the efficacy of the rehabilitation process.
- Being tested
- OneStep Smartphone Application
- Keywords
- Gait analysis, Chronic pain, Smartphone app, Rehabilitation, Adherence and Compliance
- Medical subject headings
- Signs and Symptoms, Chronic Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneStep Smartphone ApplicationOther
OneStep technology is a smartphone application (app) utilizing smartphone sensors to provide ongoing gait diagnostics. The eligible study participants will be asked to download and install the app on their own smartphones and carry the smartphone in their front pants pocket at all times.
The app will collect the required gait parameters but, will not present them (or any summary thereof) to the study participants or their physiotherapists, in order not to influence the rehabilitation plan.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Fifty (n=50) consecutive patients with lower-extremity disability or chronic pain (unilateral or bilateral), undergoing a rehabilitation course in a Day-Care Center setting. Receives: Other: OneStep Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Distance (General Gait Parameter)
The daily walking distance (in meters) as measured by the OneStep App
Measured: One month of follow-up
Walking Time (General Gait Parameter)
The daily walking time (in minutes) as measured by the OneStep App
Measured: One month of follow-up
Step Count (General Gait Parameter)
The daily step count (number of steps) as measured by the OneStep App
Measured: One month of follow-up
Step Time (Leg Specific Parameter)
The average daily step time (in seconds) as measured by the OneStep App
Measured: One month of follow-up
Motion of the Hip Joint (Leg Specific Parameter)
The daily range of hip joint motion (in degrees) as measured by the OneStep App while walking.
Measured: One month of follow-up
Patients' Adherence with the Rehabilitation Regime
The patients' adherence with the rehabilitation regime refers to the quantity and frequency of completed home exercises, converted into an adherence score. Patients' self-reports and physiotherapists' own assessments on patients' adherence will be collected using newly developed questionnaires, while the objective data on patients' adherence will be collected using the OneStep App.
Measured: One month of follow-up
Patients' Compliance with the Rehabilitation Regime
The patients' compliance with the rehabilitation regime refers to the quality of meeting the physiotherapists' walking-related recommendations, converted into a Compliance score. Patients' self-reports and physiotherapists' own assessments on patients' compliance will be collected using newly developed questionnaires, while the objective data on patients' compliance will be collected using the OneStep App.
Measured: One month of follow-up
Secondary outcomes (3)
6-Minute Walk Test (6MWT)
It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance (in meters) covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Each study subject will take this test 3 times: on days 1, 14, and 28 of the follow-up. During these tests, the study participants will be using 2 phones, each preinstalled with the OneStep application and placed on each foot for simultaneous data collection, for within and between-subject comparison.
Measured: Assessed at days 1, 14 and 28 of the follow-up period
Timed Up and Go (TUG) Test
The test measures, in seconds, the time taken by an individual to stand up from a standard armchair walk a distance of 3 meters, turn, walk back to the chair, and sit down again. The subjects are asked to wear their regular footwear and use their customary walking aids. No physical assistance is given. The subjects start the test with their back against the chair, their arms resting on the armrests, and their walking aid at hand. They are instructed that on the word "go" they are to get up and walk at a comfortable and safe pace to a line on the floor 3 meters away, turn, return to the chair and sit down again. Each subject walks through the test once before being timed in order to become familiar with the test. Each subject will take this test 3 times (days 1, 14, and 28). During these tests, the study participants will be using 2 phones, each preinstalled with the OneStep app and placed on each foot for simultaneous data collection, for within and between-subject comparison.
Measured: Assessed at days 1, 14 and 28 of the follow-up period
10-Meter Walk Test (10MWT)
The test is used to measure gait speed (in meters per second) of individuals with gait limitations. A 10-meter straight course will be marked at its beginning and end with tape on the floor. The study participant will be positioned 2 meters behind the first tape line. The subject will then be instructed to walk at a comfortable rate until one passes the second tape line. The timer is started when one crosses the first tape line and stopped when one crosses the second tape line. The 2-meter distances before and after the course serve to minimize the effect of acceleration and deceleration. The test is repeated 3 times and the average time is calculated. Each study subject will take these tests on 3 occasions (days 1, 14, and 28). During these tests, the study participants will be using 2 phones, each preinstalled with the OneStep application and placed on each foot for simultaneous data collection, for within and between-subject comparison.
Measured: Assessed at days 1, 14 and 28 of the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jul 2020
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Gefen Doron, Reuth Rehabilitation Hospital
- Investigators
- Dana Gefen Doron, MD, Principal investigator, Reuth Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012891
- Sponsor's protocol ID
- 0008-20-RRH
- Status last verified
- Apr 2022
- First submitted
- 12 Jul 2020
- Last updated
- 8 Apr 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 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis in Patients Undergoing Rehabilitation Due to Lower Extremity Disability or Chronic Pain, Using OneStep Smartphone Application.
- ClinicalTrials.gov ID
- NCT05012891
- Acronym / sponsor ID
- 0008-20-RRH
- Keywords
- Gait analysis, Chronic pain, Smartphone app, Rehabilitation, Adherence and Compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 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.
OneStep technology is a smartphone application, utilizing smartphone sensors to provide ongoing gait diagnostics. In this longitudinal study, 50 consecutive patients with lower-extremity disability or chronic pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual rehabilitation treatments, during a one-month period. Analyzed gait data from the App will be linked with clinical data collected by a team of experts, in order to evaluate the potential use of this App as an objective means to characterize and quantify patients' gait characteristics along the follow-up period, and to objectively assess the patients' adherence and compliance with the rehabilitation regime.
Detailed description
Background:
Patient adherence is a crucial determinant of the rehabilitation process. After injury or surgery, many patients are given specific exercises to conduct unsupervised on their own to aid their recovery. Evidence suggests that noncompliance with the prescribed exercise regime is associated with poor rehabilitation outcomes. OneStep technology is a smartphone application (App), which uses smartphone sensors to provide ongoing gait diagnostics.
Study Objectives:
- To analyze gait-related parameters collected via the OneStep App in patients with lower extremity disability or chronic pain over a 4-week follow-up period during in-hospital physiotherapy sessions, self-exercises at home, and other daily activities,
- To objectively assess the patients' adherence and compliance with the prescribed rehabilitation regime. For the purposes of this research, adherence refers to the quantity and frequency of completed home exercises, while compliance refers to the quality of meeting the physiotherapists' walking-related recommendations.
- To assess gait parameters measured simultaneously on both feet, during standard walking-related tests, (performed under similar conditions on days 1, 14, 28, while using the OneStep App), for between and within-subject comparison.
- To compare between patients' subjective self-reports on performed physiotherapy workouts at home, the physiotherapists' own subjective assessments on their patients' adherence and compliance, and the objective data collected using the OneStep App
Methods:
Fifty consecutive patients with lower-extremity disability or pain, will be using the One-Step App, downloaded to their personal smartphones, in parallel with the usual rehabilitation treatments, during a one-month period. The study participants will be asked to carry the smartphone with the preinstalled app on them at all times, specifically on their injured foot.
All participants will also be required to undertake standard walking tests at the study initiation day (day 1) and on days 14 and 28 under similar conditions for between and within-subject comparison. Only during these tests will the subjects be using two smartphones preinstalled with the OneStep App, one attached to each leg, for a more accurate gait symmetry assessment.
During these 3 sessions, the study participants, as well as their physiotherapists, will be asked to fill in the study questionnaires.
Hypothesis:
Data collected using the OneStep App will allow an accurate and informative follow-up on patients' adherence and compliance with the rehabilitation regime and assist the physiotherapists in improving the efficacy of the rehabilitation process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: OneStep Smartphone ApplicationFifty (n=50) consecutive patients with lower-extremity disability or chronic pain (unilateral or bilateral), undergoing a rehabilitation course in a Day-Care Center setting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a lower-extremity disability or chronic pain (unilateral or bilateral). (Chronic pain was defined as pain lasting more than 3 months)
Key inclusion criteria (7 listed)
- Men and women aged 18 to 65 years old.
- Able to walk independently or with assistance (human/walking aids).
- Able to speak and read fluently in Hebrew.
- Admitted for rehabilitation at a rehabilitation hospital day-care center following lower-extremity disability or chronic pain (unilateral or bilateral).
- Have undergone at least 4 weeks of rehabilitation, but require an additional (at least one month long) rehabilitation course.
Key exclusion criteria (4 listed)
- Subject unable to step on the sore foot.
- Subject unfit to participate in the study based on the judgment of the study principal investigator.
- Subjects who are permanently wheelchair-bound.
- Subjects with known pregnancy.
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 ApplicationOneStep technology is a smartphone application (app) utilizing smartphone sensors to provide ongoing gait diagnostics. The eligible study participants will be asked to download and install the app on their own smartphones and carry the smartphone in their front pants pocket at all times. The app will collect the required gait parameters but, will not present them (or any summary thereof) to the study participants or their physiotherapists, in order not to influence the rehabilitation plan. | Other | Study Population |
Primary outcome
Walking Distance (General Gait Parameter)
Time frame: One month of follow-up
The daily walking distance (in meters) as measured by the OneStep App
Walking Time (General Gait Parameter)
Time frame: One month of follow-up
The daily walking time (in minutes) as measured by the OneStep App
Step Count (General Gait Parameter)
Time frame: One month of follow-up
The daily step count (number of steps) as measured by the OneStep App
Step Time (Leg Specific Parameter)
Time frame: One month of follow-up
The average daily step time (in seconds) as measured by the OneStep App
Motion of the Hip Joint (Leg Specific Parameter)
Time frame: One month of follow-up
The daily range of hip joint motion (in degrees) as measured by the OneStep App while walking.
Patients' Adherence with the Rehabilitation Regime
Time frame: One month of follow-up
The patients' adherence with the rehabilitation regime refers to the quantity and frequency of completed home exercises, converted into an adherence score. Patients' self-reports and physiotherapists' own assessments on patients' adherence will be collected using newly developed questionnaires, while the objective data on patients' adherence will be collected using the OneStep App.
Patients' Compliance with the Rehabilitation Regime
Time frame: One month of follow-up
The patients' compliance with the rehabilitation regime refers to the quality of meeting the physiotherapists' walking-related recommendations, converted into a Compliance score. Patients' self-reports and physiotherapists' own assessments on patients' compliance will be collected using newly developed questionnaires, while the objective data on patients' compliance will be collected using the OneStep App.
3 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
Timed Up and Go (TUG) Test
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
10-Meter Walk Test (10MWT)
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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 7 inclusion and 4 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 8 Apr 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?
Walking Distance (General Gait Parameter) (time frame: One month of follow-up). The study lists 7 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 8 Apr 2022.