NCT07730086

Brief Summary

This observational study will evaluate whether a smartphone's built-in accelerometer can provide accurate and repeatable measurements of walking in children with unilateral spastic cerebral palsy. Thirty-five children aged 6 to 12 years will complete two walking trials along a 10-meter indoor walkway at their usual comfortable speed. During each trial, a smartphone will be secured over the lower back at the L4-L5 level to record body acceleration using the Phyphox application. At the same time, a video camera will record the child's walking for analysis using Kinovea software. Measurements obtained from the smartphone will be compared with measurements obtained from video analysis. The study will assess walking velocity, cadence, stride timing, and gait asymmetry. The two repeated walking trials will also be used to determine whether the smartphone measurements are consistent when the test is repeated during the same session. The study does not involve any treatment or change to the child's usual medical or physical therapy care. The purpose is to determine whether smartphone-based gait assessment may be a practical, low-cost method for evaluating walking in children with unilateral spastic cerebral palsy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 16, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Smartphone AccelerometryGait AnalysisSpatiotemporal Gait ParametersUnilateral Spastic Cerebral PalsyHemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

  • Walking Velocity Measured by Smartphone Accelerometry

    Walking velocity, expressed in meters per second, will be calculated by dividing the 10-meter walking distance by the time required to complete the walkway. Velocity derived from smartphone linear accelerometry using the Phyphox application will be compared with velocity obtained from frame-by-frame 2-dimensional video analysis using Kinovea software.

    Baseline

  • Cadence Measured by Smartphone Accelerometry

    Cadence, expressed as steps per minute, will be calculated from acceleration peak intervals recorded by the smartphone using the Phyphox application. Smartphone-derived cadence will be compared with cadence determined by visual frame-by-frame analysis of the simultaneous Kinovea video recording.

    Baseline

  • Gait Asymmetry Index

    The Gait Asymmetry Index will be calculated using temporal gait data from the affected and unaffected lower limbs. The index will quantify the degree of asymmetry between the two sides. Smartphone-derived asymmetry values will be compared with values obtained from the simultaneous Kinovea video analysis. Higher values indicate greater gait asymmetry.

    Baseline

Study Arms (1)

Children With Unilateral Spastic Cerebral Palsy

A convenience sample of 35 children aged 6 to 12 years with unilateral spastic cerebral palsy and Gross Motor Function Classification System levels I or II. All participants will complete two 10-meter walking trials while smartphone accelerometry and simultaneous 2-dimensional video gait analysis are performed. No treatment will be assigned or modified.

Diagnostic Test: Smartphone-Embedded Gait Assessment

Interventions

A Samsung Galaxy A7 smartphone will be secured horizontally over the participant's lower back at the L4-L5 vertebral level using an adjustable waist belt. The smartphone's built-in linear accelerometer and the Phyphox application will record movement during two 10-meter walking trials performed at a comfortable, self-selected speed. Simultaneous video recordings will be analyzed using Kinovea software as the reference method. Walking velocity, cadence, stride timing, and gait asymmetry will be calculated. The two trials will be separated by a seated rest period of 5 to 10 minutes.

Children With Unilateral Spastic Cerebral Palsy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of children aged 6 to 12 years with a clinical diagnosis of unilateral spastic cerebral palsy will be recruited from the Deraya University outpatient clinic. Eligible participants will be classified as Gross Motor Function Classification System level I or II and must be able to walk independently for 10 meters without physical assistance or handheld mobility aids. Participants must also be able to understand and follow simple verbal instructions required for gait assessment.

You may qualify if:

  • Clinical diagnosis of unilateral spastic cerebral palsy.
  • Chronological age ranging from 6 to 12 years.
  • Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
  • Ability to comprehend and execute simple verbal instructions during clinical evaluation.

You may not qualify if:

  • History of lower extremity corrective orthopedic surgery or joint casting within the preceding 12 months.
  • Botulinum Toxin Type A injections administered to the lower limbs within the past 6 months.
  • Fixed structural bony deformities or rigid joint contractures in the lower extremities.
  • Severe, uncorrected visual or auditory deficits that threaten safety or test execution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university, faculty of pharmacy

Minya, Menia Governorate, Egypt

RECRUITING

Related Publications (7)

  • Schow, E., Bugge, C., & Jensen, K. (2014). Trunk accelerometry using a smartphone for standard clinical gait evaluation: A reliability study. Journal of NeuroEngineering and Rehabilitation, 11(1), 37.

    BACKGROUND
  • Plotnik M, Giladi N, Hausdorff JM. A new measure for quantifying the bilateral coordination of human gait: effects of aging and Parkinson's disease. Exp Brain Res. 2007 Aug;181(4):561-70. doi: 10.1007/s00221-007-0955-7. Epub 2007 May 15.

    PMID: 17503027BACKGROUND
  • Fernández-González, P., Carratalá-Tejada, M., Monge-Pereira, E., & Miangolarra-Page, J. C. (2020). Reliability and validation of 2D video analysis using Kinovea software for assessment of spatiotemporal gait parameters. Medical Engineering & Physics, 78, 45-51.

    BACKGROUND
  • Almqvist, L., & Riad, J. (2020). Accelerometer-based gait analysis in children with cerebral palsy: Validation and clinical utility of spatiotemporal parameters. Developmental Medicine & Child Neurology, 62(7), 834-840.

    BACKGROUND
  • Silsupadol P, Teja K, Lugade V. Reliability and validity of a smartphone-based assessment of gait parameters across walking speed and smartphone locations: Body, bag, belt, hand, and pocket. Gait Posture. 2017 Oct;58:516-522. doi: 10.1016/j.gaitpost.2017.09.030. Epub 2017 Sep 23.

    PMID: 28961548BACKGROUND
  • Balsalobre-Fernandez C, Tejero-Gonzalez CM, del Campo-Vecino J, Bavaresco N. The concurrent validity and reliability of a low-cost, high-speed camera-based method for measuring the flight time of vertical jumps. J Strength Cond Res. 2014 Feb;28(2):528-33. doi: 10.1519/JSC.0b013e318299a52e.

    PMID: 23689339BACKGROUND
  • Staacks, S., Hütz, S., Heinke, H., & Stampfer, J. (2018). Advanced smartphone-based experiments with phyphox. Physics Education, 53(4), 045009.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 28, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations