NCT06473298

Brief Summary

The study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.

Trial Health

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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 Jul 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 7, 2024

Last Update Submit

June 22, 2024

Conditions

Keywords

Visual Light Tracking

Outcome Measures

Primary Outcomes (1)

  • Effect of Visual light tracking intervention on quality of walking, selective motor control and sensory processing of the study group compared to control group with different intervention.

    The quality of walking as step length will be assessed using Kinovea software. Selective motor control will be assessed using Selective Control Assessment of the Lower Extremity (points). Sensory processing will be assessed using the Sensory Profile Caregiver Questionnaire(points).

    Baseline

Study Arms (2)

Visual light tracking program

EXPERIMENTAL

Visual light tracking program

Other: Visual Light Tracking

Selective physical therapy program

EXPERIMENTAL

Selective physical therapy program

Other: Visual Light Tracking

Interventions

visual light tracking program consists of 10 tasks every task lasts for 6 minutes and may be repeated for the child especially in the first sessions to give him trials to him/her to understand the exercise.

Selective physical therapy programVisual light tracking program

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranged from (4-7 years).
  • They will be able to walk independently.
  • They will have intact auditory pathways.
  • They will have intact visual pathways.
  • They will have a mild degree of spasticity graded from 1 to 1+ according to the modified Ashworth scale
  • They will be mentally stable.

You may not qualify if:

  • Any other neuromuscular disorders.
  • Convulsion.
  • Botox injection
  • Fixed deformities of lower limbs and spine.
  • Selective dorsal rhizotomy (SDR).
  • Children with spasticity more than 1+ according to the modified Ashworth scale.
  • Children with visual disorders such as squint myopia.
  • children with auditory problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Mahmoud Ahmed Abdelmoneim, B.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor's degree in Physical Therapy

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 25, 2024

Study Start

July 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations