Clinical trial NCT05012891: Gait Analysis Using OneStep Smartphone Application
Official title: Gait Analysis in Patients Undergoing Rehabilitation Due to Lower Extremity Disability or Chronic Pain, Using OneStep Smartphone Application.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain of Left Foot (Finding)
Chronic Pain of Right Foot (Finding)
Keywords: Gait analysis
Chronic pain
Smartphone app
Rehabilitation
Adherence and Compliance
Lead sponsor: Reuth Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief 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 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking Distance (General Gait Parameter)
timeFrame: One month of follow-up
measure: Walking Time (General Gait Parameter)
timeFrame: One month of follow-up
measure: Step Count (General Gait Parameter)
timeFrame: One month of follow-up
measure: Step Time (Leg Specific Parameter)
timeFrame: One month of follow-up
measure: Motion of the Hip Joint (Leg Specific Parameter)
timeFrame: One month of follow-up
measure: Patients' Adherence with the Rehabilitation Regime
timeFrame: One month of follow-up
measure: Patients' Compliance with the Rehabilitation Regime
timeFrame: One month of follow-up
Secondary outcomes:
measure: 6-Minute Walk Test (6MWT)
timeFrame: Assessed at days 1, 14 and 28 of the follow-up period
measure: Timed Up and Go (TUG) Test
timeFrame: Assessed at days 1, 14 and 28 of the follow-up period
measure: 10-Meter Walk Test (10MWT)
timeFrame: Assessed at days 1, 14 and 28 of the follow-up period
Other outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Assessed at days 1, 14 and 28 of the follow-up period
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Assessed at days 1, 14 and 28 of the follow-up period
measure: ABC Confidence Scale
timeFrame: Assessed at days 1 and 28 of the follow-up period
measure: Video Documentation
timeFrame: Recorded on days 1, 14 and 28 of the follow-up period
Locations:
city: Tel Aviv
country: Israel
facility: Reuth Rehabilitation Hospital
Study officials:
affiliation: Reuth Rehabilitation Hospital
name: Dana Gefen Doron, MD
role: PRINCIPAL_INVESTIGATOR
References: