Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children

Effect of Mechanical Vestibular Stimulation On Hand Function In Children With Hemiparetic Cerebral Palsy

The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for reaching, grasping, releasing, and manipulating objects is often compromised

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: The design exercise program; Other: mechanical vestibular stimulation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt
      • Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children will be included in the study if they fulfil the following criteria:

  1. Diagnosed with hemiparetic cerebral palsy.
  2. Age ranged from 4 to 6 years.
  3. Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale
  4. Both genders will be included.
  5. The child will be able to follow verbal commands and instructions.

Exclusion Criteria:

• Children will be excluded from the study if:

  1. Any congenital or developmental disorders in addition to hemiplegia cerebral palsy.
  2. Current hospitalization for urgent medical reasons.
  3. Severe mental retardation.
  4. Children having visual or auditory defects.
  5. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to the wrist and hand.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; The child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy.	Other: The design exercise program; A selected therapeutic exercises program was based on the principles of NDTBobath neurodevelopmental therapy, which is effective in controlling spasticity in children with cerebral palsy and improving motor function. i. Preparation of structures and mobilizations of the scapula, shoulder joint, and chest according to the NDT-Bobath concept ii. Exercises to increase shoulder mobility and elbow joint extension. iii. Fine motor skill exercises, wrist, and hand
Experimental: Group B; The child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins.	Other: The design exercise program; A selected therapeutic exercises program was based on the principles of NDTBobath neurodevelopmental therapy, which is effective in controlling spasticity in children with cerebral palsy and improving motor function. i. Preparation of structures and mobilizations of the scapula, shoulder joint, and chest according to the NDT-Bobath concept ii. Exercises to increase shoulder mobility and elbow joint extension. iii. Fine motor skill exercises, wrist, and hand; Other: mechanical vestibular stimulation; Device produces mechanical vestibular stimulation. The child was placed in a sitting position on the swing and his hands grasping the ropes at the sides then the therapist stood behind him and begin pushing the platform in fast and jerky movements in back and front, side to side, and in spinning directions with the child trying to maintain his balance in all different directions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fine motor skills	We will use Peabody Developmental Motor Scale (PDMS-2) to measure visual motor integration, grasp and fine motor.	3 month
pinch strength	We will use Hand Dynamometer to measure pinch strength.	3 month

Collaborators and Investigators

• Sponsor: Ahmed Mohamed Abd El Haleem Ghoniem

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2023
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: EG, KFS lab 2 Research

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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