- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04651283
Effect of Using Adaptive Seating Equipment on Hand Function (hemiparesis)
Effect of Using Adaptive Seating Equipment on Grasping and Visual Motor Integration in Children With Hemiparetic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis.
In this study, a total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls) aged 3-6 years, they were selected from general hospitals and private centers in kafr El-Sheikh government, randomly assigned to either the control group (n=15), who received a specially selected physical therapy program for hand function on standard chair seating, or the study group (n=15), who received the same selected program for hand function but on adaptive Swiss ball seating. Both groups received 3 sessions per week for 3 successive months. Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment, to assess 2 subtests (grasping skills and visual motor integration skills).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with hemiparetic cerebral palsy.
- The age of the selected children ranged from 3 to 6 years old.
- Degree of spasticity ranged from 1 to 1+, according to Modified Ashworth' Scale (Bohannon and Smith, 1987)
- They were able to follow instructions and understand commands included in both assessment and training procedures.
- They were able to sit independent with trunk control.
Exclusion Criteria:
- Children exposed to orthopedic surgeries or potolinium toxins injection in the last 6 mounth before intervention.
- Children with fixed upper limb deformities
- Children with hearing or visual impairments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Adaptive seating equipment group
Study group who received the same selected program for hand function on adaptive swiss ball seating
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Each child in the study group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
Other Names:
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Active Comparator: Traditional seat group
Control group who received a specially selected physical therapy program for hand function on a standard chair seating.
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Each child in the control group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change is being assessed in grasping score
Time Frame: Change from Baseline grasping score assessed at 3 months
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Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome
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Change from Baseline grasping score assessed at 3 months
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change is being assessed in visual motor integration score
Time Frame: Change from Baseline visual motor integration score assessed at 3 months
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Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome
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Change from Baseline visual motor integration score assessed at 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mai Abbass, Ph.D., Cairo University
- Principal Investigator: Ahmed Mahrous, Msc, Cairo University
- Study Chair: Elham Salem, Ph.D., 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC\012\001765
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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