Clinical trial NCT03626077: Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Biofeedback
Visual-Motor Integration
Visual Perception
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed
timeFrame: 10-15 minutes total, it is taken at baseline and after 3 months of treatment
Secondary outcomes:
measure: Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed
timeFrame: 5 minutes, it is taken at baseline and after 3 months of treatment
measure: Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed
timeFrame: 5 minutes, it is taken at baseline and after 3 months of treatment
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Disabled Children's Association
state: Alnakeel
Study officials:
affiliation: Princess Nourah Bint Abdulrahman University
name: Reem M Alwhaibi, PhD
role: PRINCIPAL_INVESTIGATOR
References: