Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy

Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy

Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?

Study Overview

• Status: Recruiting
• Conditions: Balance Problems in Spastic Hemiplegic Children; Walking Performance in Spastic Hemiplegic Children
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.

To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Not yet recruiting
    • Physical Therapy
  • Cairo, Egypt
    • Recruiting
    • Physical Therapy
    • Contact: physical therapy, doctoral; Phone Number: 02 37617691; Email: un.grad@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ranges from 7 to 11 years old, from both genders.
• Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
• They were able to stand and walk.
• Gross motor function measure scale GMFM (level I &II). (Russell et al. ,2013).
• Children with good mentality to understand the evaluation steps.

Exclusion Criteria:

• Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
• Children who have any spinal deformities.
• Children with severe muscle contracture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: children treated by the traditional physical therapy program based on Neurodevelopmental technique; Twenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month	Device: Virtual Reality; children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
EXPERIMENTAL: children treated by Virtual Reality for 15 min. besides the traditional physical therapy program; twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game.	Device: Virtual Reality; children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
EXPERIMENTAL: children treated by Balance Beam for 15 min besides the traditional physical therapy program; Twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward).	Device: Virtual Reality; children treated by Virtual Reality for 15 min. besides the traditional physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance it will be assist by HUMAC Balance Assessment system	Evaluation materials that used in assist balance : HUMAC Balance Assessment system consists of: 1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial	6 month
Walking ability	Evaluation materials Six Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.	6 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: 012/003683

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No