NCT07265154

Brief Summary

Effect of Using Artificial Intelligence on Gait Training in Above Knee Amputation Patients

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 23, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 23, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

AmputationAbove Knee AmputationArtificial IntelligenceGait training

Outcome Measures

Primary Outcomes (3)

  • Medio-lateral Stability Index (MLSI)

    Medio-lateral Stability Index (MLSI) represents fluctuations from the horizontal around the mediolateral axis

    Day 0, Day 30

  • Anterior-posterior Stability Index (APSI)

    Anterior-posterior Stability Index (APSI) represents fluctuations from the horizontal around the anteroposterior axis

    Day 0, Day 30

  • Overall Stability Index (OSI)

    Overall Stability Index (OSI) a composite of MLSI and APSI so it is sensitive to changes in both directions

    Day 0, Day 30

Study Arms (2)

group A

EXPERIMENTAL

Gait Training Using Artificial Intelligence

Device: Artificial Intelligence

group B

NO INTERVENTION

Traditional Physical Therapy Program

Interventions

using artificial intelligence in gait training for above knee amputee

group A

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All patients have above-knee amputations.
  • All patients have no other neurological diseases affecting gait.
  • All patients have no other neurological diseases affecting muscle balance.
  • All patients have no other complications affecting joint ROM.

You may not qualify if:

  • Patients have any complications affecting joint ROM.
  • Patients have any neurological condition affecting muscle balance.
  • Patients have any neurological condition affecting gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy,

Banhā, Benha, 83523, Egypt

RECRUITING

Related Publications (9)

  • Hartley H, Cassidy E, Bunn L, Kumar R, Pizer B, Lane S, Carter B. Exercise and Physical Therapy Interventions for Children with Ataxia: A Systematic Review. Cerebellum. 2019 Oct;18(5):951-968. doi: 10.1007/s12311-019-01063-z.

  • Tatla SK, Radomski A, Cheung J, Maron M, Jarus T. Wii-habilitation as balance therapy for children with acquired brain injury. Dev Neurorehabil. 2014 Feb;17(1):1-15. doi: 10.3109/17518423.2012.740508. Epub 2012 Dec 11.

  • 1. Nehad A. Abo-Zaid, Nesma A Helmy, Nader I Elsayed, Amira H Mohammed. Wii Sport versus task-oriented training on gait in unilateral cerebral palsy: A randomized controlled trial. Conference: Journal of Human Sport and Exercise. Autumn Conferences of Sports Science2021.16. Proc2.36, doi: 10.14198/jhse.

    RESULT
  • Abo-Zaid NA, El-Gendy AM, Hewidy I, Essam Ali M, Sabbahi A. Influence of aerobic exercise on inhibitory control of executive functions in children with hemiplegic cerebral palsy: A randomized controlled trial. Clin Rehabil. 2024 Mar;38(3):337-346. doi: 10.1177/02692155231208578. Epub 2023 Oct 26.

  • 27. Nehad A Abo-zaid, Hebatallah M Zaghloul, Heba A Khalifa., Mohammed E Ali, Mohamed Y Abdelsamee. Efficacy of Lower Extremity Mirror Therapy on Balance in Children with Hemiplegic Cerebral Palsy: A Randomized Controlled Trial International Journal of Psychosocial Rehabilitation, 2020, Vol. 24, Issue 08

    RESULT
  • Nolan L, Grigorenko A, Thorstensson A. Balance control: sex and age differences in 9- to 16-year-olds. Dev Med Child Neurol. 2005 Jul;47(7):449-54. doi: 10.1017/s0012162205000873.

  • Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.

  • Dewar R, Love S, Johnston LM. Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Jun;57(6):504-20. doi: 10.1111/dmcn.12660. Epub 2014 Dec 18.

  • 45. Rafaela Ribeiro da Silva, Cristina Iwabe-Marchese. Using virtual reality for motor rehabilitation in a child with ataxic cerebral palsy: case report. Fisioter Pesq. 2015; 22(1):97-102, doi.org/10.590/1809-2950/13375322012015

    RESULT

Central Study Contacts

Mohammed E. Ali, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 4, 2025

Study Start

December 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations