NCT05740020

Brief Summary

This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

February 13, 2023

Last Update Submit

January 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • GROSS MOTOR PERFORMANCE

    we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance. this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value

    3 monthes

  • BALANCE

    we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value

    3 monthes

Study Arms (2)

Group (A)

EXPERIMENTAL

Group (A) will receive virtual reality in addition to the traditional exercise program.

Device: virtual reality glassesOther: The traditional exercise program

Group (B)

ACTIVE COMPARATOR

Group (B) will receive traditional exercise program.

Other: The traditional exercise program

Interventions

A specialized VR glasses will be used and VR games application in spider cage

Group (A)

The selected physical therapy program: 1. Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4). 2. Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5). 3. Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6). 4. Strengthening exercise: aims to improve the functional ability (figure 7). 5. Spider suspension exercise for 30 minutes (figure 8). 5\. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).

Group (A)Group (B)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children will be included in the study if they fulfil the following criteria:
  • A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
  • Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS).
  • Their age range from 6 to 12 years.
  • Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques.

You may not qualify if:

  • Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:
  • They had a permanent deformity (bony or soft tissue contractures).
  • Children having visual or auditory defects.
  • Current hospitalization for urgent medical reasons.
  • Severe mental retardation.
  • Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
  • Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy

Kafr ash Shaykh, Kafrelsheikh, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
SPONSOR INVESTIGATOR
PI Title
bachelor's degree of physical therapy

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations