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Completed

NCT Number: NCT03626077

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

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).

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Disabled Children's Association

Riyadh, Alnakeel, 11055, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical therapy program

Other

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.

E-Link Upper Limb Exerciser

Device

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.

physical therapy program and E-Link Upper Limb Exerciser

Combination Product

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 outcomes

  1. Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed

    Time frame: 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 outcomes

  1. Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed

    Time frame: 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

  2. Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed

    Time frame: 5 minutes, it is taken at baseline and after 3 months of treatment

    it evaluates subject motor coordination through tracing within a confined space

Sponsors and collaborators

Lead sponsor

Princess Nourah Bint Abdulrahman University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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