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Inter- and Intra-Rater Reliability of a Wearable Inertial Sensor for Spatiotemporal Gait Assessment in Stroke Survivors

NCT07650331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2026-06-16

No results posted yet for this study

Summary

Background and Objective:

Stroke frequently impairs gait functionality, leading to significant limitations in functional independence and quality of life. Objective gait analysis is essential for evaluating clinical status and rehabilitation progress. While laboratory-bound, non-wearable systems are considered the gold standard, their high cost, complex infrastructure, and requirement for specialized personnel limit their routine implementation in daily clinical practice. Portable inertial measurement units have emerged as a practical, low-cost alternative for motion analysis outside traditional laboratory settings. However, evidence regarding specific commercial devices in pathological populations remains limited. This study aims to evaluate the inter-rater and intra-rater reliability of the commercially available Baiobit® lumbar-mounted inertial sensor for measuring spatiotemporal gait parameters in stroke survivors.

Methodology:

A prospective, single-group, repeated-measures design was conducted at a specialized neurorehabilitation clinic (Neuron Clinic, Madrid). A convenience sample of 22 adults diagnosed with subacute or chronic stroke who were able to ambulate independently was included. Gait assessments were performed by two trained evaluators across two separate sessions spaced 24 to 48 hours apart. During each session, the Baiobit® sensor was secured to the participants' sacral region (S1-S2) using an adjustable belt. Participants performed three 10-meter walking trials at their comfortable, self-selected pace for each evaluator. Reliability was quantified using Intraclass Correlation Coefficients (ICC), Standard Error of Measurement (SEM), and Minimal Detectable Change (MDC).

Expected Outcomes:

It is hypothesized that the Baiobit® inertial sensor will demonstrate adequate relative and absolute inter- and intra-rater reliability across spatiotemporal gait parameters, supporting its viability as an objective monitoring tool in routine stroke rehabilitation clinical settings.

Conditions

Sponsors & Collaborators

  • Neuron, Spain

    lead OTHER

Principal Investigators

  • Alejandro Herrera Rojas, Physical Therapist · Neuron, Spain

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-04-20
Completion
2026-05-14

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650331 on ClinicalTrials.gov