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Completed

NCT Number: NCT07233031

Effectiveness of Universal Exercise Unit Exercise on Upper Limb Strength Using Biodex Isokinetic

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

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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, 11432, Egypt

About this study

This study is designed to answer the following question:

Is there an effect of designed program in universal exercise unit on upper limb function and strength in children with spastic hemiplegia? Purpose of The Study The purpose 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.

Null Hypothesis Is there is no role of designed program in the universal exercise unit on the upper limb in children with spastic hemiplegia.

The study was concluded forty children with spastic hemiplegic cerebral palsy from both sexes had been selected from according to the following criteria:

  • children ages were ranged from 5-9 years old.
  • The children had spasticity grades 1, 1+ degree according to Modified Ashworth scale
  • The children were selected to be in level I and II GMFCs
  • The children were selected to be in level II MACs participants had been excluded if they had the following:
  • Visual or hearing impairment
  • Orthopedic surgery of upper limbs for the last 6 months
  • Cardiopulmonary diseases Children were equally assigned into two groups using simple randomization, control group (A) and study group (B). Each group would consist of 20 children with spastic hemiplegia CP.

Group (A): Children in this group received a selected physical therapy program. Group (B): Children in this group received the selected physical therapy program in addition to a designed physical therapy program in UEU.

Evaluation was carried out for each child individually before and after 3 months of treatment.

A-For Assessment

  • The Quality of Upper Extremity Skill Test (Quest) The QUEST test included 34 items in four domains of (dissociated movement, grasp, weight bearing and protective extension).

Each child was instructed to hold the position for at least two seconds. 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)

  • The Biodex Isokinetic system The testing session had been started with a warm up procedure, consisting of shoulder movements in all directions, push up-exercises against the wall and stretching. For the testing procedure, the closed chain attachment was fixed to the isokinetic dynamometer in a horizontal position. Essentially, this device converts rotational motion at the dynamometer into linear motion, allowing closed kinematic chain or linear movements The evaluation was carried out for each child individually before and after three month of treatment.

Tested muscles were elbow flexors, elbow extensor, shoulder flexors, shoulder extensors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Experimental

Procedure

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

Control (Standard treatment)

Other

traditional physio therapy program.

Primary outcomes

  1. The Quality of Upper Extremity Skill Test

    Time frame: 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)

    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.

Secondary outcomes

  1. The Biodex Isokinetic system

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

    The testing session had been started with a warm up procedure, consisting of shoulder movements in all directions, push up-exercises against the wall and stretching Tested muscles were elbow flexors, elbow extensor, shoulder abductors, shoulder adductors

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

ROLE OF DESIGNED PROGRAM IN UNIVERSAL EXERCISE UNIT ON UPPER LIMB IN CHILDREN WITH SPASTIC HEMIPLEGIA

Acronym: UEU/CP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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