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

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).

Study Overview

• Status: Unknown
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Procedure: physical therapy program; Device: E-Link Upper Limb Exerciser; Combination product: physical therapy program and ELink Upper Limb Exerciser

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reem M Alwhaibi, PhD; Phone Number: +966599112273 +966599112273; Email: rmalwhaibi@pnu.edu.sa
• Study Contact Backup: Name: Reem M Alwhaibi; Phone Number: +966599112273 +966599112273; Email: rmalwhaibi@pnu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 25058
    • Recruiting
    • Disabled Children's Association
    • Contact: Reem M Alwhaibi; Phone Number: +966599112273 +966599112273; Email: rmalwhaibi@pnu.edu.sa
    • Contact: Reham M Alsakhawi, phd; Phone Number: +966504182628; Email: RSMahmoud@pnu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: group A; Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months	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.
ACTIVE_COMPARATOR: group B; Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)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
EXPERIMENTAL: group C; group (C) physical therapy program and E-Link Upper Limb Exerciser	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Princess Nourah Bint Abdulrahman University
• Investigators: Principal Investigator: Reem M Alwhaibi, PhD, Princess Nourah bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): December 20, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (ACTUAL): November 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Biofeedback; eye-hand coordination; Peabody
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 205-w-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No