Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742999
• Other study ID #: 205-w-37
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: November 2018
• Source: Princess Nourah Bint Abdulrahman University
• Contact: Reem M Alwhaibi, PhD
• Phone: +966599112273
• Email: rmalwhaibi[@]pnu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 1, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Procedure:
• physical therapy program
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.

Device:
• E-Link Upper Limb Exerciser
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

Combination Product:
• physical therapy program and ELink Upper Limb Exerciser
physical therapy program and E-Link Upper Limb Exerciser. Children were trained for 60 minutes per session, three times a week for three months

Locations

Country	Name	City	State
Saudi Arabia	Disabled Children's Association	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	10-15 minutes total, it is taken at base line and after 3 months of treatment