NCT05463718

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

June 19, 2022

Last Update Submit

July 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

children treated by the traditional physical therapy program based on Neurodevelopmental technique

EXPERIMENTAL

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

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 Balance Beam for 15 min besides the traditional physical therapy program

EXPERIMENTAL

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

Interventions

children treated by Virtual Reality for 15 min. besides the traditional physical therapy program

children treated by Balance Beam for 15 min besides the traditional physical therapy programchildren treated by Virtual Reality for 15 min. besides the traditional physical therapy programchildren treated by the traditional physical therapy program based on Neurodevelopmental technique

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physical Therapy

Cairo, Egypt

NOT YET RECRUITING

Physical Therapy

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Pediatrics department, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

June 19, 2022

First Posted

July 19, 2022

Study Start

August 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-01

Locations