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

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

Augmented Biofeedback Training Combined With Physical Therapy Program Improves Visual-motor Integration, Visual Perception and Motor Coordination in Children With Spastic Hemiplegic Cerebral Palsy: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626077
• Other study ID #: 205-S-37
• Status: Completed
• Phase: N/A
• Start date: September 3, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: August 2018
• Source: Princess Nourah Bint Abdulrahman University
• Contact: n/a
• 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 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, and 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, or severe cognitive impairment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Other:
• 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 E-Link 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	Alnakeel

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	Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed	it evaluate the subject's ability to integrate visual and motor skills, through copying	10-15 minutes total, it is taken at baseline and after 3 months of treatment
Secondary	Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed	it evaluates subject visual perception (VP) and motor coordination matching shapes to stimulus form	5 minutes, it is taken at baseline and after 3 months of treatment
Secondary	Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed	it evaluates subject motor coordination through tracing within a confined space	5 minutes, it is taken at baseline and after 3 months of treatment