Reliability and Validity of the OneStep Smartphone Application for Gait Analysis

NCT05009303 | Unknown DMC

• 1 other identifier: 0003-21-RRH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Expanding the availability of quantitative tools for gait quality assessment is essential to enable clinicians to analyze patient's gait, monitor gait changes, and modify the rehabilitation process, when gold-standard tools are not available. The OneStep technology is a smartphone application (app), that uses smartphone sensors to provide ongoing gait diagnostics. This study aims to further evaluate the analytical capability of the OneStep algorithm in recording and analyzing gait parameters and test its reliability and validity. The study will take place at Reuth Rehabilitation Hospital. All participants will be using the App and the C-Mill treadmill (Motek, Amsterdam, Netherlands) built-in gait analysis system, during two separate treadmill walks of up to 15 minutes. All walking sessions will be recorded with two cameras. Data obtained from participants will be collected and analyzed for gait parameters. The study sample will include 30 healthy volunteers and 70 patients.

Conditions

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

Keywords

gait analysis; chronic pain; smartphone app; rehabilitation; validation; test-retest reliability

Outcome Measures

Primary Outcomes (8)

• Cadence

  Number of steps per minute \[in steps per minute\]

  A walking session of up to 15 minutes

• Gait Speed

  Time one takes to walk a specified distance \[Expressed as ratio between distance and time, in meters per second\]

  A walking session of up to 15 minutes

• Stride Length

  Distance \[in cm\] covered when one takes two steps, one with each foot, measured from ipsilateral heel contact to the next ipsilateral heel contact (right-to-right or left-to-left heel)

  A walking session of up to 15 minutes

• Step Length

  The distance \[in cm\] between the heel strike of one foot and the heel strike of the opposite foot (measured separately for each foot)

  A walking session of up to 15 minutes

• Swing Phase Duration

  The swing phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. \[Expressed in seconds or as percentage of the gait cycle\] (measured separately for each foot)

  A walking session of up to 15 minutes

• Stance Phase Duration

  The stance phase of gait begins when the foot first touches the ground and ends when the same foot leaves the ground. \[Expressed in seconds or as percentage of the gait cycle\] (measured separately for each foot)

  A walking session of up to 15 minutes

• Single Limb Support Duration

  Part of the swing phase where only one limb in in contact with the ground \[Expressed in seconds or as percentage of the stance phase\] (measured separately for each foot)

  A walking session of up to 15 minutes

• Double Limb Support Duration

  Part of the swing phase where both limbs are in contact with the ground \[Expressed in seconds or as percentage of the stance phase\]

  A walking session of up to 15 minutes

Study Arms (1)

Participants

Thirty healthy individuals and seventy patients suffering from chronic pain or disability in one or both of their lower extremities

Device: OneStep Smartphone App and C-Mill Treadmill

Interventions

OneStep Smartphone App and C-Mill Treadmill DEVICE

OneStep technology is a smartphone application that utilizes smartphone sensors to provide ongoing gait diagnostics. Each participant will have two sessions, during which, they will walk on a C-Mill smart treadmill for up to 15 minutes (with a minimum of 2 minutes), while carrying 2 smartphones and being recorded via two video cameras. The second walking session, conducted under similar conditions, will be used for test-retest reliability.

Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample size of 100 participants (30 healthy individuals and 70 patients) was chosen for the study, which includes men and women, of different age groups, with various lower limb disability levels and functional capacities.

You may qualify if:

• Men and women aged 18 to 65.
• Able to walk independently or with assistance (human / walking aids).
• Able to speak and read in Hebrew fluently.
• Patients requiring lower limb rehabilitation course (inpatient/outpatient) due to lower limb disability or chronic pain
• Ability to successfully complete a routine 6-minute walking test (as part of treatment)
• Mini-Mental State Examination (MMSE) Score ≥ 24

You may not qualify if:

• Subjects requiring prosthetics or orthoses.
• Subject unable to step on their foot.
• Subject unfit to participate in the study according to the judgment of the principal investigator, including but not limited to:
• Known pregnancy. 3.2 Existing cardio-pulmonary disease. 3.3 Balance impairment 3.4 visual disturbances (not rectified by glasses) 3.5 history of falls
• As walking on the treadmill with a walking aid will not be allowed, patients unable to walk without a walking aid will be excluded (use of handrails during walking will be permitted).

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Signs and Symptoms; Chronic Pain

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

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: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 17, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

IL (1)