Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05012891
Status:
UNKNOWN
Last Update Posted:
2022-04-08
First Post:
2020-07-12
Brief Title:
Gait Analysis Using OneStep Smartphone Application
Sponsor:
Reuth Rehabilitation Hospital
Organization:
Reuth Rehabilitation Hospital
Study Overview
Official Title:
Gait Analysis in Patients Undergoing Rehabilitation Due to Lower Extremity Disability or Chronic Pain Using OneStep Smartphone Application
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None