Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
physical therapy program
E-Link Upper Limb Exerciser
physical therapy program and ELink Upper Limb Exerciser
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Biofeedback, eye-hand coordination, Peabody
Eligibility Criteria
Inclusion Criteria:
- Grade of spasticity between 1 to 1+ according to Modified ashworth Scale,
- The ability to handle objects independently was between level (I) and (II)
- According to Manual Ability Classification System (MACS)
- No history of epilepsy
- No botulinum toxin A treatment for the upper extremities in the previous 6 months
- Able to understand and follow verbal commands and instructions
Exclusion Criteria:
- Presence of visual or auditory impairments
- Significant tightness or fixed deformities in the upper limbs
- Severe spasticity
- Autism
- Severe cognitive impairment
Sites / Locations
- Disabled Children's AssociationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
group A
group B
group C
Arm Description
Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months
Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months
group (C) physical therapy program and E-Link Upper Limb Exerciser
Outcomes
Primary Outcome Measures
Change from Baseline Peabody Developmental Motor Scale at 3 months (2nd edition) (PDMS-2)
Peabody Developmental Motor Scale provides assessment and training or remediation of gross and fine motor skills for children. It composed of two scores (Gross Motor and Fine Motor) divided into six subtests (Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, Visual-Motor Integration).
scale ranges from 2, 1, or 0 ( 2 is the better outcome, 0 is the worse outcome)
Secondary Outcome Measures
Full Information
NCT ID
NCT03742999
First Posted
November 10, 2018
Last Updated
November 14, 2018
Sponsor
Princess Nourah Bint Abdulrahman University
1. Study Identification
Unique Protocol Identification Number
NCT03742999
Brief Title
Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy
Official Title
Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Nourah Bint Abdulrahman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate potential benefits of adding augmented biofeedback training to standard therapy in improving eye-hand coordination in children with hemiplegic cerebral palsy .Participants were divided randomly into three equal groups. Group (A) received specially designed program of physical therapy intervention strategies to facilitate visual motor integration and visual perception over a period of three months. Group (B) received augmented biofeedback training only, and group (C) received augmented biofeedback training and same physical therapy program as group (A).
Detailed Description
Children were assigned randomly into three groups of equal number (A, B and C). Children were selected randomly by collecting all names of children that matched the inclusion criteria of the study then upload the names and gender using an electronic program (SPSS) which divided the sample into three equal groups (A), (B) & (C). Group A: this group included fifteen children with spastic hemiplegic CP. Children of this group received specially designed program of physical therapy exercises to facilitate eye-hand coordination to improve visual-motor coordination and grasping skills, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip. The tools used in training program were: button strip, lacing strip and its lace, mottle with screw- on cap, markers with different colors, beads and its lacing, square cubes, pellets, papers, blunt scissors, colored cubes, different types of form board and its shapes. Adjusted chair and table were used to accommodate differences in children's body built. Children were trained for 60 minutes per session, three times a week for three consecutive months.
Group B: this group included fifteen children with spastic hemiplegic CP. Children of this group received training using the E-Link Upper Limb Exerciser for 60 minutes per session, three times a week for three consecutive months. Group C: this group included fifteen children with spastic hemiplegic CP. Children of this group received the same physical therapy program as conducted for group A, and training with E-Link Upper Limb Exerciser as conducted for group B. The training was for 60 minutes per session, three times a week for three consecutive months.
The participated children were assessed by the Peabody Developmental Motor Scale (2nd edition) (PDMS-2) Test before and after the three months of the treatment program. The average time required for evaluating each child was 40 min. The assessment and training methods were applied according to the instructions provided in the test and equipment manuals, no modifications were necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Biofeedback, eye-hand coordination, Peabody
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months
Arm Title
group C
Arm Type
Experimental
Arm Description
group (C) physical therapy program and E-Link Upper Limb Exerciser
Intervention Type
Procedure
Intervention Name(s)
physical therapy program
Intervention Description
this group received specially designed physical therapy program to facilitate eye-hand coordination and fine motor to improve VMI, VP and MC, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip. Children were trained for 60 minutes per session, three times a week for three consecutive months.
Intervention Type
Device
Intervention Name(s)
E-Link Upper Limb Exerciser
Intervention Description
The exercises in the E-Link Upper Limb Exerciser System are in the form of simple and exciting games such as soccer, hitting walls, space shooting, driving, arnd throwing balls into a bucket.Children were trained for 60 minutes per session, three times a week for three consecutive months
Intervention Type
Combination Product
Intervention Name(s)
physical therapy program and ELink Upper Limb Exerciser
Intervention Description
physical therapy program and E-Link Upper Limb Exerciser. Children were trained for 60 minutes per session, three times a week for three months
Primary Outcome Measure Information:
Title
Change from Baseline Peabody Developmental Motor Scale at 3 months (2nd edition) (PDMS-2)
Description
Peabody Developmental Motor Scale provides assessment and training or remediation of gross and fine motor skills for children. It composed of two scores (Gross Motor and Fine Motor) divided into six subtests (Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, Visual-Motor Integration).
scale ranges from 2, 1, or 0 ( 2 is the better outcome, 0 is the worse outcome)
Time Frame
10-15 minutes total, it is taken at base line and after 3 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Grade of spasticity between 1 to 1+ according to Modified ashworth Scale,
The ability to handle objects independently was between level (I) and (II)
According to Manual Ability Classification System (MACS)
No history of epilepsy
No botulinum toxin A treatment for the upper extremities in the previous 6 months
Able to understand and follow verbal commands and instructions
Exclusion Criteria:
Presence of visual or auditory impairments
Significant tightness or fixed deformities in the upper limbs
Severe spasticity
Autism
Severe cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem M Alwhaibi, PhD
Phone
+966599112273
Ext
+966599112273
Email
rmalwhaibi@pnu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Reem M Alwhaibi
Phone
+966599112273
Ext
+966599112273
Email
rmalwhaibi@pnu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem M Alwhaibi, PhD
Organizational Affiliation
Princess Nourah Bint Abdulrahman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disabled Children's Association
City
Riyadh
ZIP/Postal Code
25058
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem M Alwhaibi
Phone
+966599112273
Ext
+966599112273
Email
rmalwhaibi@pnu.edu.sa
First Name & Middle Initial & Last Name & Degree
Reham M Alsakhawi, phd
Phone
+966504182628
Email
RSMahmoud@pnu.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data from participants will be made available
IPD Sharing Time Frame
12 months after study completion
IPD Sharing Access Criteria
data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement.
Learn more about this trial
Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy
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