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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04894812
Other study ID # REC/00757 Anam Tariq
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2021
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment. This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).


Description:

There are various therapeutic approaches that are used to improve motor activities and postural control in CP child. Among these approaches vestibular stimulation is used to improve neuromotor development by different sensory stimulation techniques. It has shown positive effects on motor control of CP child. It also influences all sensory experiences and is an exercise based approach.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - Age: 3 years to 12 years - Gender: Both Male and female - Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale - Level III and IV on GMFCS (Gross Motor Function Classification System) Exclusion Criteria: - Children with other types of Cerebral Palsy (diplegia, quadriplegia etc) - Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc) - Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc) - Children with any other neurological deficits (spina bifida etc) - Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Neurodevelopmental technique
st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist. nd month: balance and corrective reactions; using CP ball and tilt board. rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars).

Locations

Country Name City State
Pakistan Institute of Pediatric Habilitation and Rehabilitation IPH Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Bangash AS, Hanafi MZ, Idrees R, Zehra N. Risk factors and types of cerebral palsy. J Pak Med Assoc. 2014 Jan;64(1):103-7. — View Citation

Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41. — View Citation

Tramontano M, Medici A, Iosa M, Chiariotti A, Fusillo G, Manzari L, Morelli D. The Effect of Vestibular Stimulation on Motor Functions of Children With Cerebral Palsy. Motor Control. 2017 Jul;21(3):299-311. doi: 10.1123/mc.2015-0089. Epub 2016 Aug 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary GMFM-88 It is a Standardized Observational Instrument designed and validated to measure change in gross motor function over time in children with Cerebral Palsy. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest, selected goal areas and a total GMFM-88 score. 12 weeks
Secondary Modified Ashworth Scale The purpose of the Modified Ashworth Scale is to measure spasticity in patients who have lesions of the CNS or neurological disorders. The MAS is a quick and easy measure that can assist a clinician's assessment of spasticity during passive soft-tissue stretching. 12 weeks
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