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Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy

Primary Purpose

Hypotonic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional physiotherapy
Vestibular stimulation with conventional physiotherapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotonic Cerebral Palsy focused on measuring vestibular stimulation, motor function, balance

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age range from 5-10 years.
  • both male/female
  • have good head control
  • hypotonic cerebral palsy
  • able to maintained ring sitting position

Exclusion Criteria:

  • children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation
  • children with un controlled convulsion or vp shunt
  • children with severe medical problems children with orthopedic condition

Sites / Locations

  • Mahwash ZulfiqarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

training duration for each session is 30 mints with 5 mints rest and it includes passive soft tissue elogation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing

It included passive soft tissue elongation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing and Vestibular Stimulation exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair, gaze stabilization exercises and visual pursuit exercises under supervision.

Outcomes

Primary Outcome Measures

Gross motor
A motor skill is a function, which involves precise movement of muscles with the intent to perform a specific act. Most purposeful movement requires the ability to "feel" or sense what one's muscles are doing as they perform the act. To measure the gross motor, gross motor function classification system is used. Gross motor function measure: The gross motor skill (sitting walking) of children and young people with cerebral palsy can be categorized into different level using a tool called gross motor function classification scale. Gross motor function scale has total of five levels. Level 1 is the lowest while level 5 is the highest. Higher level means worst outcome
Balance:
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position. Normal balance depends on information from the inner ear, other senses (such as sight and touch) and muscle movement. To measure the balance, pediatric balance scale is used. Pediatric Balance Scale: The pediatric balance scale is modified version of Berg Balance that is used to assess functional balance skill in school-aged children they have 14 components and a total of 56 score. The minimum score is 0 and 56 is the maximum score. Higher score means good outcome

Secondary Outcome Measures

Full Information

First Posted
November 16, 2021
Last Updated
December 16, 2021
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05162092
Brief Title
Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
Official Title
Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Anticipated)
Study Completion Date
March 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

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
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises
Detailed Description
my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotonic Cerebral Palsy
Keywords
vestibular stimulation, motor function, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study participants will be randomized in two groups,conventional physiotherapy group and intervention group
Masking
Care ProviderOutcomes Assessor
Masking Description
double (care provider ,outcome assessor)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
training duration for each session is 30 mints with 5 mints rest and it includes passive soft tissue elogation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing
Arm Title
Group B
Arm Type
Experimental
Arm Description
It included passive soft tissue elongation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing and Vestibular Stimulation exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair, gaze stabilization exercises and visual pursuit exercises under supervision.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Participants will be given Conventional Physiotherapy. It included Passive Soft tissue elongation of tight muscles, Lower limb resistance exercises, Movement transitions, balance board and foam board standing, walking and stair climbing.
Intervention Type
Other
Intervention Name(s)
Vestibular stimulation with conventional physiotherapy
Intervention Description
Participants in group B will be given conventional physiotherapy and vestibular stimulation exercises. It included conventional is same as given to the conventional and Vestibular Stimulation
Primary Outcome Measure Information:
Title
Gross motor
Description
A motor skill is a function, which involves precise movement of muscles with the intent to perform a specific act. Most purposeful movement requires the ability to "feel" or sense what one's muscles are doing as they perform the act. To measure the gross motor, gross motor function classification system is used. Gross motor function measure: The gross motor skill (sitting walking) of children and young people with cerebral palsy can be categorized into different level using a tool called gross motor function classification scale. Gross motor function scale has total of five levels. Level 1 is the lowest while level 5 is the highest. Higher level means worst outcome
Time Frame
5 weeks
Title
Balance:
Description
A biological system that enables us to know where our bodies are in the environment and to maintain a desired position. Normal balance depends on information from the inner ear, other senses (such as sight and touch) and muscle movement. To measure the balance, pediatric balance scale is used. Pediatric Balance Scale: The pediatric balance scale is modified version of Berg Balance that is used to assess functional balance skill in school-aged children they have 14 components and a total of 56 score. The minimum score is 0 and 56 is the maximum score. Higher score means good outcome
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age range from 5-10 years. both male/female have good head control hypotonic cerebral palsy able to maintained ring sitting position Exclusion Criteria: children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation children with un controlled convulsion or vp shunt children with severe medical problems children with orthopedic condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahwash zulfiqar Khan, msptn
Phone
03355077906
Email
zulfiqar1991khan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
bilal umer
Organizational Affiliation
The university of lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
anam naz
Organizational Affiliation
The university of lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahwash Zulfiqar
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahwish Zulfiqar, MS MSK PT
Phone
03355077906

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy

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