NCT06721663

Brief Summary

To investigate the Effect of Multisensory environment stimulation therapy on postural control in spastic hemiplegic cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 3, 2024

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • biodex balance system

    EVALUATION OF POSTURAL BALANCE USINGTHE BIODEX BALANCE SYSTEM

    three months

  • The Pediatric Balance Scale

    used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

    three months

Secondary Outcomes (1)

  • multidirection reach test

    three months

Study Arms (2)

study group

EXPERIMENTAL
Other: Multisensory environment stimulation therapyOther: selected physical therapy intervention

control group

EXPERIMENTAL
Other: selected physical therapy intervention

Interventions

A Multi Sensory Environment is a dedicated space or room where sensory stimulation can be controlled (intensified or reduced), presented in isolation or combination, packaged for active or passive interaction

study group

therapeutic balance training and functional therapeutic exercises

control groupstudy group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Forty children with cerebral palsy,
  • Age will range as (9:12) years old
  • spastic hemiplegic cerebral palsy
  • Normal body mass index standardmore than 50th and less than 85th for age and sex compared to standard Egyptian growth charts adopted by the Faculty of Medicine, Cairo University and National Research Centre.
  • Gross motor function classification system: level I\&II

You may not qualify if:

  • difficulty to communicate or to understand program instructions
  • any other neurological deficits or orthopaedic abnormalities,
  • secondary musculoskeletal complication
  • vestibular problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama S Mahmoud

Al Jīzah, Select State, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

December 15, 2024

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations