Back to resultsEffect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mechanical vestibular stimulation
The design exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria: Children will be included in the study if they fulfil the following criteria: Diagnosed with hemiparetic cerebral palsy. Age ranged from 4 to 6 years. Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale Both genders will be included. The child will be able to follow verbal commands and instructions. Exclusion Criteria: Children will be excluded from the study if: Any congenital or developmental disorders in addition to hemiplegia cerebral palsy. Current hospitalization for urgent medical reasons. Severe mental retardation. Children having visual or auditory defects. 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.
Sites / Locations
- Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
The child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy.
The child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins.
Outcomes
Primary Outcome Measures
fine motor skills
We will use Peabody Developmental Motor Scale (PDMS-2) to measure visual motor integration, grasp and fine motor.
pinch strength
We will use Hand Dynamometer to measure pinch strength.
Secondary Outcome Measures
Full Information
NCT ID
NCT05782413
First Posted
February 24, 2023
Last Updated
March 13, 2023
Sponsor
Ahmed Mohamed Abd El Haleem Ghoniem
1. Study Identification
Unique Protocol Identification Number
NCT05782413
Brief Title
Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
Official Title
Effect of Mechanical Vestibular Stimulation On Hand Function In Children With Hemiparetic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Abd El Haleem Ghoniem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
The child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy.
Arm Title
Group B
Arm Type
Experimental
Arm Description
The child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins.
Intervention Type
Other
Intervention Name(s)
mechanical vestibular stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The design exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
fine motor skills
Description
We will use Peabody Developmental Motor Scale (PDMS-2) to measure visual motor integration, grasp and fine motor.
Time Frame
3 month
Title
pinch strength
Description
We will use Hand Dynamometer to measure pinch strength.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children will be included in the study if they fulfil the following criteria:
Diagnosed with hemiparetic cerebral palsy.
Age ranged from 4 to 6 years.
Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale
Both genders will be included.
The child will be able to follow verbal commands and instructions.
Exclusion Criteria:
Children will be excluded from the study if:
Any congenital or developmental disorders in addition to hemiplegia cerebral palsy.
Current hospitalization for urgent medical reasons.
Severe mental retardation.
Children having visual or auditory defects.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M. Ghoniem, B.Sc
Phone
+201224632571
Email
Ahmed_pg01@pt.kfs.edu.eg
Facility Information:
Facility Name
Physical Therapy
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M. Ghoniem, B.Sc
Phone
+201224632571
Email
Ahmed_pg01@pt.kfs.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
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