- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367477
Horizontal Versus Vertical Upper Extremity Function in Bilateral Cerebral Palsy
HORIZONTAL VERSUS VERTICAL UPPER EXTREMITY PERFORMANCE ON HAND SKILLS AND TRUNK CONTROL IN BILATERAL CEREBRAL PALSY
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.
Study Overview
Status
Conditions
Detailed Description
This study aims to investigate the effects of 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. The research will evaluate fine motor proficiency, upper extremity function and trunk stability from sitting through a controlled and structured intervention program.
Participants will undergo designed Occupational Therapy program will be applied for 90 minutes, three days per week for successive three months for the both groups by the researcher The study adopts a quasi-experimental design, with thirty participants allocated into two groups of an equal number, twenty children for each group. Two group will be identified as group (A) and group (B).
Data will be analyzed using paired t-test will be used for within group comparison before and after the intervention, for each variable and independent t-test was used to compare the demographic data and the baseline characteristics of both groups for all measured variables, pre and post treatments, with a significance level set at p < 0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 11511
- Faculty of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
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Active Comparator: Group (A)
Children in this group will receive a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.
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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.
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Experimental: Group (B)
Children in this group will receive the same designed OT program given to group (A) conducted on a vertical surface.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Fine motor proficiency
Time Frame: Before and after the three months of treatment
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Evaluated using the fine motor form of the Bruinink-Oseretsky test for motor proficiency 2nd edition (BOT-2)
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Before and after the three months of treatment
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Change in upper extremity function
Time Frame: Before and after the three months of treatment
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Evaluated using the Quality of Upper Extremity Skills Test (QUEST)
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Before and after the three months of treatment
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Change in trunk stability from sitting
Time Frame: Before and after the three months of treatment
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Evaluated using the Trunk Control Measurement Scale (TCMS) to assess static and anticipatory trunk control
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Before and after the three months of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: 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 Director: 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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/012/004404
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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