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

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
physical therapy program
E-Link Upper Limb Exerciser
physical therapy program and E-Link Upper Limb Exerciser
Sponsored by
Princess Nourah Bint Abdulrahman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Biofeedback, Visual-Motor Integration, Visual Perception

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Disabled Children's Association

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

group A

group B

group C

Arm Description

Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months

Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months

group (C) physical therapy program and E-Link Upper Limb Exerciser

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed
it evaluates subject motor coordination through tracing within a confined space

Full Information

First Posted
August 4, 2018
Last Updated
August 9, 2018
Sponsor
Princess Nourah Bint Abdulrahman University
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1. Study Identification

Unique Protocol Identification Number
NCT03626077
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2017 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Nourah Bint Abdulrahman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Biofeedback, Visual-Motor Integration, Visual Perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months
Arm Title
group C
Arm Type
Experimental
Arm Description
group (C) physical therapy program and E-Link Upper Limb Exerciser
Intervention Type
Other
Intervention Name(s)
physical therapy program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
E-Link Upper Limb Exerciser
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
physical therapy program and E-Link Upper Limb Exerciser
Intervention Description
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 Outcome Measure Information:
Title
Beery-Buktenica Developmental Test of Visual-Motor Integration (6th edition) "change" is being assessed
Description
it evaluate the subject's ability to integrate visual and motor skills, through copying
Time Frame
10-15 minutes total, it is taken at baseline and after 3 months of treatment
Secondary Outcome Measure Information:
Title
Beery-Buktenica Developmental Test- Visual Perception test. "change" is being assessed
Description
it evaluates subject visual perception (VP) and motor coordination matching shapes to stimulus form
Time Frame
5 minutes, it is taken at baseline and after 3 months of treatment
Title
Beery-Buktenica Developmental Test-Motor Coordination test. "change" is being assessed
Description
it evaluates subject motor coordination through tracing within a confined space
Time Frame
5 minutes, it is taken at baseline and after 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem M Alwhaibi, PhD
Organizational Affiliation
Princess Nourah Bint Abdulrahman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disabled Children's Association
City
Riyadh
State/Province
Alnakeel
ZIP/Postal Code
11055
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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