An observational study in Chronic Pain of Left Foot (Finding) and Chronic Pain of Right Foot (Finding), sponsored by Reuth Rehabilitation Hospital. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Reuth Rehabilitation Hospital · Observational
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.
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:
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.
2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 12 is below the median of 126 across 687 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Reuth Rehabilitation Hospital is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a lower-extremity disability or chronic pain (unilateral or bilateral).
(Chronic pain was defined as pain lasting more than 3 months)
Exclusion Criteria:
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.
Other: OneStep Smartphone Application
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.
Walking Distance (General Gait Parameter)
The daily walking distance (in meters) as measured by the OneStep App
Time frame: One month of follow-up
Walking Time (General Gait Parameter)
The daily walking time (in minutes) as measured by the OneStep App
Time frame: One month of follow-up
Step Count (General Gait Parameter)
The daily step count (number of steps) as measured by the OneStep App
Time frame: One month of follow-up
Step Time (Leg Specific Parameter)
The average daily step time (in seconds) as measured by the OneStep App
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One month of follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a multidimensional measurement tool, which contains a figure of the body on which patients can mark their painful sites. The 4-item BPI Pain Severity Subscale is used to measure overall pain: at its worst, at its least, on average (all - over the last 24 hours) and at present, using a 0-10 numeric rating scale, where 0 indicates no pain and 10 corresponds to "severe or excruciating pain as bad as you can imagine". The BPI has seven Numeric Rating Scales (NRS) that show how the pain interferes with function, mood, and enjoyment.
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
Lower Extremity Functional Scale (LEFS)
The LEFS is a 20-item self-report measure of physical function. Each item is rated on a five-point scale (0-4), with lower scores representing greater difficulty. Total scores can range from 0 to 80. Function is defined as follows: extreme difficulty or unable to perform activity (0-19 points), quite a bit of difficulty (20-39 points), moderate difficulty (40-59 points), a little bit of difficulty (60-79 points), and no difficulty (80 points).
Time frame: Assessed at days 1, 14 and 28 of the follow-up period
ABC Confidence Scale
Self administered 16 question assessment in which subjects are instructed to answer each question with a percentage of confidence that they will not fall while performing a given task from 0%-100%, with 0% being "not confident" and 100% being "confident". Scores 80% or higher indicate a high level of physical functioning, 50-80% indicate a moderate level of physical functioning and scores less than 50% indicate a low level of physical functioning.
Time frame: Assessed at days 1 and 28 of the follow-up period
Video Documentation
Subjects will be videotaped during their performance in the Six Minute Walk Test, Ten Meter Walk Test and Timed Up and Go Test to visually assess and document any changes in gait parameters, from baseline measurements. The videotaping procedures will focus only on the subject's lower extremities.
Time frame: Recorded on days 1, 14 and 28 of the follow-up period
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reuth Rehabilitation Hospital