Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782413
• Other study ID #: EG, KFS lab 2 Research
• Status: Completed
• Phase: N/A
• Start date: December 3, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Physical Therapy	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Mohamed Abd El Haleem Ghoniem

Country where clinical trial is conducted

Egypt, 

Outcome

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