NCT07367477

Brief Summary

The goal of this quasi-experimental study is to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy; could include any of the following: both gender, age ranged from 5 years to 8 years. The main question it aims to answer \[is/are\]: There will be no significant difference effect between horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress58%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 16, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 26, 2026

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Fine motor proficiency

    Evaluated using the fine motor form of the Bruinink-Oseretsky test for motor proficiency 2nd edition (BOT-2)

    Before and after the three months of treatment

  • Change in upper extremity function

    Evaluated using the Quality of Upper Extremity Skills Test (QUEST)

    Before and after the three months of treatment

  • Change in trunk stability from sitting

    Evaluated using the Trunk Control Measurement Scale (TCMS) to assess static and anticipatory trunk control

    Before and after the three months of treatment

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

Children in this group will receive a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.

Procedure: a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.

Group (B)

EXPERIMENTAL

Children in this group will receive the same designed OT program given to group (A) conducted on a vertical surface.

Procedure: a designed occupational therapy program to improvement hand skills conducted on a vertical surface.

Interventions

The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a vertical surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months.

Group (B)

The treatment session will be started by the following exercises for 30 minutes as preparation for hand skill training and the second part of the session will be exercises facilitating fine motor skills a horizontal surface for one hour, Three sessions per week will last for 90 minutes, for successive Three months.

Group (A)

Eligibility Criteria

Age5 Years - 8 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with BSCP, their chronological age will be ranged from 5 years to 8 years.
  • Their level of motor function will be I or II according to Gross Motor Function Classification System - Expanded and Revised.
  • The degree of spasticity for these children will ranged from grade 1 to 1⁺ according to Modified Ashworth Scale.
  • Their level of fine motor function will be I or II according to The Bimanual Fine Motor Function.
  • All children's level of segmental trunk control will be level 7 (full trunk control) according to Segmental Assessment of Trunk Control.
  • They will be able to follow instructions during evaluation and treatment.

You may not qualify if:

  • Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.
  • Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities.
  • Uncontrolled seizures.
  • Visual or hearing impairment.
  • Receiving special medication affecting muscle and /or mental function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, 11511, Egypt

Location

Study Officials

  • Kamal El Sayed Shoukry, Professor Doctor

    Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University

    STUDY CHAIR
  • Nanees Essam Mohamed, Professor Doctor

    Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University

    STUDY DIRECTOR
  • Gehan Mosaad Abd El-Maksoud, Professor Doctor

    Department of physical therapy for growth and developmental disorder in children and its surgery, Faculty of physical therapy, Cairo University

    STUDY DIRECTOR

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
SPONSOR INVESTIGATOR
PI Title
Physical Therapy Specialist

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

June 16, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 26, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations