NCT06989034

Brief Summary

The goal of this observational case-control study is to examine the relationship between sensory processing abilities, postural stability, and selective motor control (SMC) in children aged 6-10 years with hemiplegic cerebral palsy (CP). The study compares outcomes in children with hemiplegic CP to age-matched typically developing children (TDC). It aims to determine how differences in sensory processing may relate to motor control and balance deficits in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

May 17, 2025

Last Update Submit

May 17, 2025

Conditions

Keywords

sensory processing abilitiesPostural stabilityselective voluntary motor controlunilateral cerebral palsychild sensory profile 2

Outcome Measures

Primary Outcomes (3)

  • ensory Profile 2 (SP2) Total and Subscale Scores

    Scores across sensory domains and behavioral responses will be compared between groups and correlated with motor outcomes.

    Single assessment session (within a 1-day visit)

  • HUMAC Balance Scores (COP, LOS, mCTSIB)

    Quantitative balance parameters will be analyzed between groups.

    Single assessment session (within a 1-day visit)

  • TASC and SCALE Scores

    Selective motor control scores (range 0-2 per joint movement) will be summed and analyzed.

    Single assessment session (within a 1-day visit)

Study Arms (2)

The hemiplegic cerebral palsy (CP) group

The hemiplegic cerebral palsy (CP) group consists of 30 children diagnosed with spastic hemiplegic CP, a type of CP characterized by motor impairment predominantly on one side of the body. These children were aged between 6 and 10 years and had GMFCS levels I or II, indicating mild to moderate functional limitations. They exhibited mild spasticity, as indicated by Modified Ashworth Scale scores of 1 or 1+, and were able to follow simple instructions. The hemiplegic CP group was included to investigate sensory processing, postural stability, and selective voluntary motor control (SVMC) impairments associated with spastic hemiplegia.

Other: Child Sensory Profile 2 (SP2) for Sensory processing abilitiesOther: HUMAC Balance System for Postural stability evaluationOther: Selective Motor Control Evaluation for the upper and lower extremities

typically developing children (TDC) group

The control group consisted of 30 typically developing children (TDC) who were matched to the hemiplegic CP group based on age and sex. The control group served as a comparison to the CP group, allowing for the evaluation of typical sensory processing, postural stability, and selective voluntary motor control patterns in children without any clinical motor impairments. The children in the control group were expected to perform within typical developmental ranges for sensory and motor function, providing a baseline for assessing the motor and sensory processing deficits in the hemiplegic CP group.

Other: Child Sensory Profile 2 (SP2) for Sensory processing abilitiesOther: HUMAC Balance System for Postural stability evaluationOther: Selective Motor Control Evaluation for the upper and lower extremities

Interventions

Sensory processing abilities are evaluated using the Child Sensory Profile 2 (SP2), an 86-item caregiver questionnaire assessing six sensory systems (auditory, visual, touch, movement, body position, and oral) and three behavioral domains (conduct, social-emotional, and attentional).

The hemiplegic cerebral palsy (CP) grouptypically developing children (TDC) group

Postural stability is assessed using the HUMAC Balance System, incorporating tests such as: * The Modified Clinical Test of Sensory Integration of Balance (mCTSIB) * Limits of Stability (LOS) at difficulty levels 4 and 6 * Center of Pressure (COP) metrics

The hemiplegic cerebral palsy (CP) grouptypically developing children (TDC) group

Selective voluntary motor control is evaluated using the following tools: * Test of Arm Selective Control (TASC) for the upper extremities * Selective Control Assessment of the Lower Extremity (SCALE) for the lower extremities

The hemiplegic cerebral palsy (CP) grouptypically developing children (TDC) group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population divided into two groups. The first group includes 30 children diagnosed with spastic hemiplegic cerebral palsy (CP), a condition characterized by motor impairments affecting one side of the body due to early brain damage. These children are recruited from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. The second group includes 30 age- and sex-matched typically developing children (TDC) who have no known neurological, orthopedic, or sensory processing disorders. These children are selected from mainstream schools in Luxor Governorate and are expected to exhibit typical development in sensory processing, motor control, and postural stability. The children in the CP group are part of a clinical setting with prior diagnoses and care, while the TDC group is sourced from an educational setting. The study aims to compare sensory processing abilities, postural stability, and selective motor control

You may qualify if:

  • Diagnosis of spastic hemiplegic cerebral palsy
  • Age between 6 and 10 years
  • GMFCS levels I or II
  • Modified Ashworth Scale score of 1 or 1+ (mild spasticity)
  • Ability to follow simple instructions
  • Caregiver with sufficient English language proficiency

You may not qualify if:

  • Botulinum toxin injections within the past 6 months
  • Visual or auditory impairments
  • Orthopedic or neurosurgical intervention to limbs or spine
  • Musculoskeletal deformities
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic, Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyMotor Skills Disorders

Interventions

Sp2 Transcription Factor

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sp Transcription FactorsKruppel-Like Transcription FactorsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsTranscription Factors

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 25, 2025

Study Start

January 15, 2023

Primary Completion

August 22, 2023

Study Completion

January 2, 2024

Last Updated

May 25, 2025

Record last verified: 2025-04

Locations