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

NCT07650331 | Completed

• 1 other identifier: Baiobit validation in stroke
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

Stroke; Gait rehabilitation; Inertial measurement units; Validation

Outcome Measures

Primary Outcomes (1)

• Intra-rater reliability of spatiotemporal gait parameters

  Relative and absolute consistency of spatiotemporal gait metrics derived from repeated measurements taken by the same evaluator

  Up to 48 hours

Secondary Outcomes (1)

• Inter-rater reliability of spatiotemporal gait parameters

  Day 1 and day 2

Study Arms (1)

Participants

All the participants included

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a convenience sample of adult stroke survivors receiving outpatient physical therapy and neurorehabilitation care. Participants include individuals with a confirmed diagnosis of either ischemic or hemorrhagic stroke, in both subacute and chronic stages (time since onset greater than one month), who retain the functional capacity to ambulate independently on overground surfaces without physical assistance. All participants are recruited from the outpatient facilities of a specialized neurorehabilitation center (Neuron Clinics) located in Madrid, Spain.

You may qualify if:

• adults aged 18-85 years
• confirmed diagnosis of stroke
• ability to ambulate (FAC \> 4), regardless of foot-up use
• Capacity to walk 10m without stopping and repeat the trials 6 times across the session
• Cognitive ability to understand the study instruction and provide written informed consent

You may not qualify if:

• clinical instability or acute medical conditions that compromise gait safety
• concomitant neurological conditions other than stroke
• severe musculoskeletal disorders that interfere with gait analysis
• balance or coordination impairments secondary to visual or auditory deficits
• recent use of substances or medications that impair bait, balance, or postural control
• pregnancy
• cognitive or behavioral impairments that prevent the proper performance of the test

Sponsors & Collaborators

• Neuron, Spain: lead

Study Sites (1)

Neuron Madrid Río

Madrid, Madrid, 28045, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alejandro Herrera Rojas, Physical Therapist

  Neuron, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: October 10, 2025
• Primary Completion: April 20, 2026
• Study Completion: May 14, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be uploaded once analyzed
• Access Criteria: Anybody

Locations

ES (1)