Gait Analysis Using OneStep Smartphone Application

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain of Left Foot (Finding); Chronic Pain of Right Foot (Finding)
• Intervention / Treatment: Other: OneStep Smartphone Application

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:

1. 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,
2. 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.
3. 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.
4. 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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Reuth Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

1. Men and women aged 18 to 65 years old.
2. Able to walk independently or with assistance (human/walking aids).
3. Able to speak and read fluently in Hebrew.
4. Admitted for rehabilitation at a rehabilitation hospital day-care center following lower-extremity disability or chronic pain (unilateral or bilateral).
5. Have undergone at least 4 weeks of rehabilitation, but require an additional (at least one month long) rehabilitation course.
6. 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.
7. The subjects' smartphone has to be compatible with the OneStep app hardware requirements.

Exclusion Criteria:

1. Subject unable to step on the sore foot.
2. Subject unfit to participate in the study based on the judgment of the study principal investigator.
3. Subjects who are permanently wheelchair-bound.
4. Subjects with known pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Distance (General Gait Parameter)	The daily walking distance (in meters) as measured by the OneStep App	One month of follow-up
Walking Time (General Gait Parameter)	The daily walking time (in minutes) as measured by the OneStep App	One month of follow-up
Step Count (General Gait Parameter)	The daily step count (number of steps) as measured by the OneStep App	One month of follow-up
Step Time (Leg Specific Parameter)	The average daily step time (in seconds) as measured by the OneStep App	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.	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.	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.	One month of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Assessed at days 1, 14 and 28 of the follow-up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	Recorded on days 1, 14 and 28 of the follow-up period

Collaborators and Investigators

• Sponsor: Reuth Rehabilitation Hospital
• Investigators: Principal Investigator: Dana Gefen Doron, MD, Reuth Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Chronic pain; Gait analysis; Smartphone app; Adherence and Compliance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 0008-20-RRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No