Validity and Reliability of Gait and Jump Parameters Measured by the iSen Device in Healthy Adults

NCT06994793 | Recruiting

• 1 other identifier: KirikkaleUni-iSenSağlıklı
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the validity and reliability of gait and jumping parameters measured with the iSen device in healthy adults. Gait analysis is a valuable tool for assessing general health, cognitive performance, quality of life, and mortality. It is commonly used by clinicians to assess functional limitations resulting from neurological or orthopedic conditions and to guide treatment plans. Traditional gait assessments primarily focus on walking speed, but additional parameters such as step length, step time, and gait symmetry are crucial for a comprehensive analysis. The study will also assess vertical jump performance, which is a surrogate measure of explosive lower limb strength and is commonly used in sports performance and injury prediction. The iSen device, a wearable and affordable sensor, will be compared to the validated BTS G-Walk system to evaluate the accuracy and consistency of its measurements. Participants aged 18-35 with no history of musculoskeletal, neurological, or systemic conditions will be included. The study will be conducted at Gazi University and Kırıkkale University, where participants will undergo assessments of gait and jump performance using both iSen and BTS G-Walk devices. A test-retest reliability protocol will be employed with a seven-day interval between measurements. The results will provide evidence on the suitability of the iSen device for reliable and valid gait and jump measurements in clinical settings

Conditions

Healthy Adults; Gait Analysis; Jumping Performance; Reliability and Validity

Keywords

Gait Analysis; Jumping Performance; iSen Device; Wearable Sensors; Reliability; Validity

Outcome Measures

Primary Outcomes (15)

• Gait Speed

  Gait speed (m/s) will be measured using the iSen system at baseline and one week later. At baseline, measurements will also be collected using the BTS G-Walk system for comparison to determine the validity of the iSen device in healthy adults.

  Baseline and 1 week later

• Cadence

  Cadence (steps/min) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.

  Baseline and 1 week later

• Step Length

  Step length (m) will be measured using the iSen system at baseline and one week later. At baseline, BTS G-Walk measurements will be used for validity comparison.

  Baseline and 1 week later

• Stance Phase Duration

  Stance phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

  Baseline and 1 week later

• Step Time

  Step time (s) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for comparison.

  Baseline and 1 week later

• Swing Phase Duration

  Swing phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

  Baseline and 1 week later

• Double Support Phase Duration

  Double support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation.

  Baseline and 1 week later

• Single Support Phase Duration

  Single support phase duration (%) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation

  Baseline and 1 week later

• Pelvic Angles

  Pelvic angles (degrees) will be measured using the iSen system at baseline and one week later. BTS G-Walk will be used at baseline for validation

  Baseline and 1 week later

• Jump Height

  Jump height (cm) will be measured during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only the iSen system one week later. The highest value from three jumps will be recorded.

  Baseline and 1 week later

• Take-off Force

  Take-off force (kN) during a countermovement jump will be measured with the iSen and BTS G-Walk systems at baseline, and with iSen only one week later. The trial with the highest value will be analyzed.

  Baseline and 1 week later

• Maximum Concentric Power

  Maximum concentric power (kN) during a countermovement jump will be measured using both iSen and BTS G-Walk systems at baseline, and only iSen at one week. The value from the best trial will be used for analysis.

  Baseline and 1 week later

• Landing Impact Force

  Landing impact force (kN) will be assessed using both the iSen and BTS G-Walk systems at baseline, and the iSen system only at one-week follow-up.

  Baseline and 1 week later

• Maximum Jump Velocity

  Maximum vertical velocity (m/s) during a countermovement jump will be measured using the iSen and BTS G-Walk systems at baseline, and only iSen one week later. The maximum value from three trials will be recorded.

  Baseline and 1 week later

• Take-off Velocity

  Take-off velocity (m/s) will be assessed during a countermovement jump using both the iSen and BTS G-Walk systems at baseline, and only iSen at 1-week follow-up. The highest value will be selected.

  Baseline and 1 week later

Study Arms (1)

Healthy Adults

Healthy adult volunteers aged 18 to 35 years with no history of lower extremity surgery or any musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants were recruited from university departments and underwent gait and jumping assessments using the iSen and BTS G-Walk devices.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy adult volunteers aged 18 to 35 years who have not undergone lower extremity surgery and have no musculoskeletal, neurological, or systemic conditions that could affect gait or jumping performance. Participants will be recruited from Gazi University and Kırıkkale University, Department of Physiotherapy and Rehabilitation.

You may qualify if:

• Age between 18 and 35 years. Voluntarily agree to participate in the study. No history of surgery in the lower extremities.

You may not qualify if:

• Any musculoskeletal, neurological, or systemic pathology that could affect gait or jumping performance.
• Inability to comply with study procedures.

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kirikkale University

Kırıkkale, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.

  PMID: 30747572 BACKGROUND

• Yazici MV, Cobanoglu G, Yazici G. Test-retest reliability and minimal detectable change for measures of wearable gait analysis system (G-Walk) in children with cerebral palsy. Turk J Med Sci. 2022 Jun;52(3):658-666. doi: 10.55730/1300-0144.5358. Epub 2022 Jun 16.

  PMID: 36326313 BACKGROUND

Central Study Contacts

Saniye AYDOGAN ARSLAN

CONTACT

+905053333457; fztsaniye1982@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 29, 2025
• Study Start: January 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)