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

NCT03626077 | Completed DMC

• 1 other identifier: 205-S-37
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemiplegic Cerebral Palsy

Keywords

Biofeedback; Visual-Motor Integration; Visual Perception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

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

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

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

Study Arms (3)

group A

ACTIVE COMPARATOR

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

Other: physical therapy program

group B

ACTIVE COMPARATOR

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

group C

EXPERIMENTAL

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

Combination Product: physical therapy program and E-Link Upper Limb Exerciser

Interventions

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.

group A

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.

group B

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.

group C

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• presence of visual or auditory impairments, significant tightness or fixed deformities in the upper limbs, severe spasticity, autism, or severe cognitive impairment

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead

Study Sites (1)

Disabled Children's Association

Riyadh, Alnakeel, 11055, Saudi Arabia

Location

Study Officials

• Reem M Alwhaibi, PhD

  Princess Nourah Bint Abdulrahman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 10, 2018
• Study Start: September 3, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

SA (1)