Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Hemiplegic Cerebral Palsy
• Interventions: Combination Product: physical therapy program and E-Link Upper Limb Exerciser; Device: E-Link Upper Limb Exerciser; Other: physical therapy program

• Registration Number: NCT03626077
• Lead Sponsor: Princess Nourah Bint Abdulrahman University

Brief Summary

The aim of this study was to investigate potential benefits of adding augmented biofeedback training to standard therapy in improving visual motor integration (VMI) visual perception (VP) and motor coordination (MC) 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 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. 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 Beery-Buktenica Developmental 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 Timeline

• Study Start: 2017-09-03
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2018-08
• Study First Submitted: 2018-08-04
• Study First Submitted QC: 2018-08-09
• Last Update Submitted: 2018-08-09
• Study First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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, and able to understand and follow verbal commands and instructions

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Exclusion Criteria

• presence of visual or auditory impairments, significant tightness or fixed deformities in the upper limbs, severe spasticity, autism, or severe cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	physical therapy program and E-Link Upper Limb Exerciser	group (C) physical therapy program and E-Link Upper Limb Exerciser
group B	E-Link Upper Limb Exerciser	Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months
group A	physical therapy program	Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months

Primary Outcome Measures

Name	Time	Method
Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed	10-15 minutes total, it is taken at baseline and after 3 months of treatment	it evaluate the subject's ability to integrate visual and motor skills, through copying

Secondary Outcome Measures

Name	Time	Method
Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed	5 minutes, it is taken at baseline and after 3 months of treatment	it evaluates subject visual perception (VP) and motor coordination matching shapes to stimulus form
Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed	5 minutes, it is taken at baseline and after 3 months of treatment	it evaluates subject motor coordination through tracing within a confined space

Trial Locations

Locations (1)

Disabled Children's Association; 🇸🇦 Riyadh, Alnakeel, Saudi Arabia