NCT07233031

Brief Summary

The aim of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia. forty children with spastic hemiplegia cerebral palsy from both sexes had been selected from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University . Children were divided into two groups of equal numbers; 20 patients in each group. Group A: Children in this group received a selected physical therapy program. Group B: Children in this group received a designed physical therapy program in UEU in addition to the selected physical therapy program. A-Materials for evaluation 1- For the Quality Of Upper Extremity Skill Test (QUEST),2- Biodex Isokinetic systems.Evaluation was carried out for each child individually before and after 3 months of treatment

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 Apr 2024

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

April 10, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

universal exercise unit , muscle strength

Outcome Measures

Primary Outcomes (1)

  • The Quality of Upper Extremity Skill Test

    The Quality of Upper Extremity Skill est test included 34 items in four domains of dissociated movement, grasp, weight bearing and protective extension. All children in this study were assessed in the four domains. The total number of 'yes' and 'no' responses provide the raw score for each domain. This is then weighted and transformed into a final score range of zero to 100.

    The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)

Secondary Outcomes (1)

  • The Biodex Isokinetic system

    The evaluation was carried out for each child individually before and after three month of treatment.

Study Arms (2)

control (standard treatment)

ACTIVE COMPARATOR

children in control group received standard physiotherapy

Other: Control (Standard treatment)

experimental

EXPERIMENTAL

a designed physical therapy program in Universal exercise that began with testing one repetition maximum (1-RM). One repetition maximum (1-RM) was determined through the chest press. children had been targeted upper limb strengthening program

Procedure: Experimental

Interventions

ExperimentalPROCEDURE

designed physical therapy program in Universal exercise unit for strengthening upper limb. fundamental beginning position for every exercise. Total session time in the UEU was approximately 30 minutes. The resisted exercise targeted shoulder flexor and extensor muscles, shoulder abductor and adductor muscles and for elbow extensor muscles

experimental

traditional physio therapy program.

control (standard treatment)

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their ages were ranged from 5-9 years old.
  • They had spasticity grades 1, 1+ degree according to Modified Ashworth scale
  • They were selected to be in level I and II GMFCs They were selected to be in level II MACs

You may not qualify if:

  • Visual or hearing impairment
  • Orthopedic surgery of upper limbs for the last 6 months
  • Cardiopulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of the Faculty of Physical Therapy, Cairo University's

Cairo, 11432, Egypt

Location

Study Officials

  • Naglaa A Zaky, professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: for group A: The session time ranged between 50-60 minutes according to child cooperation and numbers of repetitions the child could do for group B: Each child performed 1 or 2 sets of 8-15 repetitions with a light to moderate load (about 60% 1- RM)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer in physical therapy faculty, department of pediatric and its surgery

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

April 10, 2024

Primary Completion

April 20, 2025

Study Completion

September 1, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations