Gait Analysis Using OneStep Smartphone Application

NCT05012891 | Unknown DMC

• 1 other identifier: 0008-20-RRH
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain of Left Foot (Finding); Chronic Pain of Right Foot (Finding)

Keywords

Gait analysis; Chronic pain; Smartphone app; Rehabilitation; Adherence and Compliance

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 6-Minute Walk Test (6MWT)

  Assessed at days 1, 14 and 28 of the follow-up period

• Timed Up and Go (TUG) Test

  Assessed at days 1, 14 and 28 of the follow-up period

• 10-Meter Walk Test (10MWT)

  Assessed at days 1, 14 and 28 of the follow-up period

Other Outcomes (4)

• Brief Pain Inventory (BPI)

  Assessed at days 1, 14 and 28 of the follow-up period

• Lower Extremity Functional Scale (LEFS)

  Assessed at days 1, 14 and 28 of the follow-up period

• ABC Confidence Scale

  Assessed at days 1 and 28 of the follow-up period

Study Arms (1)

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

Interventions

OneStep Smartphone Application OTHER

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 Population

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Signs and Symptoms; Chronic Pain; Patient Compliance

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dana Gefen Doron, MD

  Reuth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: August 19, 2021
• Study Start: July 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 30, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Locations

IL (1)