Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
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 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedStudy Start
First participant enrolled
December 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedApril 30, 2024
April 1, 2024
4 months
February 24, 2023
April 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group A
EXPERIMENTALThe child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy.
Group B
EXPERIMENTALThe child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physical Therapy
Kafr ash Shaykh, Kafrelsheikh, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Principal Investigator, faculty of physical therapy
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 23, 2023
Study Start
December 3, 2023
Primary Completion
March 21, 2024
Study Completion
March 31, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04