Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742999
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Reem M Alwhaibi, 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 eye-hand coordination 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).

Condition or disease Intervention/treatment Phase
Hemiplegic Cerebral Palsy Procedure: physical therapy program Device: E-Link Upper Limb Exerciser Combination Product: physical therapy program and ELink Upper Limb Exerciser Not Applicable

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 to improve visual-motor coordination and grasping skills, 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 the Peabody Developmental Motor Scale (2nd edition) (PDMS-2) 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A
Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months
Procedure: 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.

Active Comparator: group B
Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)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

Experimental: group C
group (C) physical therapy program and E-Link Upper Limb Exerciser
Combination Product: physical therapy program and ELink 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




Primary Outcome Measures :
  1. Change from Baseline Peabody Developmental Motor Scale at 3 months (2nd edition) (PDMS-2) [ Time Frame: 10-15 minutes total, it is taken at base line and after 3 months of treatment ]

    Peabody Developmental Motor Scale provides assessment and training or remediation of gross and fine motor skills for children. It composed of two scores (Gross Motor and Fine Motor) divided into six subtests (Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, Visual-Motor Integration).

    scale ranges from 2, 1, or 0 ( 2 is the better outcome, 0 is the worse outcome)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • Severe cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742999


Contacts
Layout table for location contacts
Contact: Reem M Alwhaibi, PhD +966599112273 ext +966599112273 rmalwhaibi@pnu.edu.sa
Contact: Reem M Alwhaibi +966599112273 ext +966599112273 rmalwhaibi@pnu.edu.sa

Locations
Layout table for location information
Saudi Arabia
Disabled Children's Association Recruiting
Riyadh, Saudi Arabia, 25058
Contact: Reem M Alwhaibi    +966599112273 ext +966599112273    rmalwhaibi@pnu.edu.sa   
Contact: Reham M Alsakhawi, phd    +966504182628    RSMahmoud@pnu.edu.sa   
Sponsors and Collaborators
Princess Nourah Bint Abdulrahman University
Investigators
Layout table for investigator information
Principal Investigator: Reem M Alwhaibi, PhD Princess Nourah Bint Abdulrahman University
Layout table for additonal information
Responsible Party: Reem M Alwhaibi, associate professor, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier: NCT03742999    
Other Study ID Numbers: 205-w-37
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data from participants will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after study completion
Access Criteria: data access requests will be reviewed by an external independent review panel. requestors will be required to sign a data access agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reem M Alwhaibi, Princess Nourah Bint Abdulrahman University:
Biofeedback
eye-hand coordination
Peabody
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases