- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233031
Effectiveness of Universal Exercise Unit Exercise on Upper Limb Strength Using Biodex Isokinetic (UEU/CP)
ROLE OF DESIGNED PROGRAM IN UNIVERSAL EXERCISE UNIT ON UPPER LIMB IN CHILDREN WITH SPASTIC HEMIPLEGIA
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11432
- Outpatient Clinic of the Faculty of Physical Therapy, Cairo University's
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control (standard treatment)
children in control group received standard physiotherapy
|
traditional physio therapy program.
|
|
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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The evaluation was carried out for each child individually before and after three month of treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Naglaa A Zaky, professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/004849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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