NCT05614713

Brief Summary

Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 6, 2022

Last Update Submit

November 6, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Assessment of balance

    Assessment by using Biodex Balance System

    After 2 months of intervention

  • Assessment of functional mobility

    Assessment by using the Timed Up and Go test

    After 2 months of intervention

Study Arms (2)

Study group

EXPERIMENTAL

received a modified selected physical therapy program to increase sensory input.

Procedure: Modified physical therapy program to increase sensory input

Control group

ACTIVE COMPARATOR

received a selected physical therapy

Procedure: Selected physical therapy program

Interventions

Selected physical therapy programPROCEDURE

Gait training and balance training

Control group
Modified physical therapy program to increase sensory inputPROCEDURE

Gait training and balance training using sensory stimulating matts

Study group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system

You may not qualify if:

  • Visual or auditory problems. Fixed deformities of lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai E Abbass, Ph.D.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mai Elsayed Abbass

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

September 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 27, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

EG(1)