NCT06531044

Brief Summary

This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 28, 2024

Last Update Submit

July 28, 2024

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyBalanceGross Motor Coordination

Outcome Measures

Primary Outcomes (2)

  • balance.

    Biodex Balance System will be used to assess balance.

    1 day - one session

  • gross motor coordination.

    \- Gross Motor - BOT -2 will be used to assess gross motor coordination.

    1 day - one session

Study Arms (1)

1 of children with cerebral palsy

Children with spastic cerebral palsy will be enrolled in this study upon fulfilling the following inclusion criteria: They were scored Level I on the Gross Motor Function Classification System (GMFCS).

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with spastic cerebral palsy

You may qualify if:

  • They were scored Level I on the Gross Motor Function Classification System (GMFCS).
  • The subjects' age was from five to eleven years.
  • They were at least 1-meter-tall and not less 20 Kg.
  • They had to comprehend verbal commands.
  • They were score 1 to 1+ based on Modified Ashworth' Scale.

You may not qualify if:

  • Contracture, deformity and/or tightness in upper or lower limbs.
  • Botulinum toxin in the last year.
  • Recent fracture.
  • Vertigo or dizziness.
  • Epilepsy.
  • Osteoporosis.
  • Recent operation in the six months at least (according to the type of operation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai University

Ismailia, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Alaa N Kora, PhD

CONTACT

01002701815alaan.kora@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

March 6, 2024

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

EG(1)