Effect of Using Adaptive Seating Equipment on Hand Function (hemiparesis)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Traditional seat group
Adaptive seating equipment group
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adaptive seating equipment group
Traditional seat group
Arm Description
Study group who received the same selected program for hand function on adaptive swiss ball seating
Control group who received a specially selected physical therapy program for hand function on a standard chair seating.
Outcomes
Primary Outcome Measures
change is being assessed in grasping score
Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome
change is being assessed in visual motor integration score
Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651283
Brief Title
Effect of Using Adaptive Seating Equipment on Hand Function
Acronym
hemiparesis
Official Title
Effect of Using Adaptive Seating Equipment on Grasping and Visual Motor Integration in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objective: The purpose 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. Subjects: A total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls), aged 3-6 years participated in this study. They were randomly assigned into control and study groups of equal numbers each consisted of fifteen children (n=15). Methods: Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment (3 sessions per week), to assess 2 subtests (the grasping skills and visual motor integration skills) for all children of both groups. Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Study group who received the same selected program for hand function on adaptive swiss ball seating.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive seating equipment group
Arm Type
Experimental
Arm Description
Study group who received the same selected program for hand function on adaptive swiss ball seating
Arm Title
Traditional seat group
Arm Type
Active Comparator
Arm Description
Control group who received a specially selected physical therapy program for hand function on a standard chair seating.
Intervention Type
Other
Intervention Name(s)
Traditional seat group
Other Intervention Name(s)
Occupational therapy program for upper limb while the child sitting on chair
Intervention Description
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):
Building towers and shapes with different textures weights and bright colors.
Inserting different shapes in the correct hole.
Dropping pellets.
Stringing beads.
Copying square and triangle.
Opening the bottle and close it.
Folding and Crumpling paper.
Cutting paper by scissors.
Tracing line and connecting dots.
Reaching above the level of shoulder.
Reaching across the midline.
Squeezing water out of a sponge.
Buttoning and unbuttoning button.
Playing clapping games.
Turning pages in a book.
Lacing string.
Picking up a small piece of food and bringing it into the palm.
Moving a penny from the palm to the fingers.
Removing socks.
Brush the teeth.
Intervention Type
Other
Intervention Name(s)
Adaptive seating equipment group
Other Intervention Name(s)
Occupational therapy program for upper limb while the child sitting on adaptive seating equipment ( swiss ball)
Intervention Description
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):
Building towers and shapes with different textures weights and bright colors.
Inserting different shapes in the correct hole.
Dropping pellets.
Stringing beads.
Copying square and triangle.
Opening the bottle and close it.
Folding and Crumpling paper.
Cutting paper by scissors.
Tracing line and connecting dots.
Reaching above the level of shoulder.
Reaching across the midline.
Squeezing water out of a sponge.
Buttoning and unbuttoning button.
Playing clapping games.
Turning pages in a book.
Lacing string.
Picking up a small piece of food and bringing it into the palm.
Moving a penny from the palm to the fingers.
Removing socks.
Brush the teeth.
Primary Outcome Measure Information:
Title
change is being assessed in grasping score
Description
Assessment of grasping using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Time Frame
Change from Baseline grasping score assessed at 3 months
Title
change is being assessed in visual motor integration score
Description
Assessment of visual motor integration using Peabody Developmental Motor Scale 2 the higher score means a better outcome
Time Frame
Change from Baseline visual motor integration score assessed at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Abbass, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Mahrous, Msc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elham Salem, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of physical therapy, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Effect of Using Adaptive Seating Equipment on Hand Function
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