NCT05782413

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

December 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

February 24, 2023

Last Update Submit

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

EXPERIMENTAL

The child will receive a design exercise program. The therapy was based on the principles of NDTBobath neurodevelopmental therapy.

Other: The design exercise program

Group B

EXPERIMENTAL

The child will receive a design exercise program for 45 min then mechanical vestibular exercise for 15 mins.

Other: mechanical vestibular stimulationOther: The design exercise program

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.

Group B

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

Group AGroup B

Eligibility Criteria

Age4 Years - 6 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:
  • 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

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
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

Locations