Back to resultsVestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
Primary Purpose
Cerebral Palsy, Hemiplegic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurodevelopmental technique
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring motor activity, spasticity, vestibular stimulation
Eligibility Criteria
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).
Sites / Locations
- Institute of Pediatric Habilitation and Rehabilitation IPH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
Neurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months
Neurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04894812
First Posted
May 19, 2021
Last Updated
February 20, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04894812
Brief Title
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
Official Title
The Effect of Vestibular Stimulation Along With Neurodevelopmental Technique on Motor Functions of Children With Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
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
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegic Cerebral Palsy
Keywords
motor activity, spasticity, vestibular stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Neurodevelopmental Treatment. Total duration of treatment will be 20 minutes, 3 sessions per for 3 months
Arm Title
Group B
Arm Type
Experimental
Arm Description
Neurodevelopmental Technique and Vestibular stimulation. Total duration of treatment will be 50 minutes (20 min NDT+ 30 MIN VS) 3 sessions per week for 3 months.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental technique
Intervention Description
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).
Primary Outcome Measure Information:
Title
GMFM-88
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Pediatric Habilitation and Rehabilitation IPH
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27633076
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.
Results Reference
background
PubMed Identifier
24605730
Citation
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.
Results Reference
background
PubMed Identifier
26221161
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.
Results Reference
background
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Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
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