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

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

Study Overview

• Status: Recruiting
• Conditions: Hypotonic Cerebral Palsy
• Intervention / Treatment: Other: Conventional physiotherapy; Other: Vestibular stimulation with conventional physiotherapy

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahwash zulfiqar Khan, msptn; Phone Number: 03355077906; Email: zulfiqar1991khan@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Mahwash Zulfiqar
      • Contact: Mahwish Zulfiqar, MS MSK PT; Phone Number: 03355077906

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; 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	Other: Conventional physiotherapy; 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.
EXPERIMENTAL: Group B; 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.	Other: Vestibular stimulation with conventional physiotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks
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	5 weeks

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: anam naz, The University of Lahore

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2021
• Primary Completion (ANTICIPATED): March 4, 2022
• Study Completion (ANTICIPATED): March 4, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (ACTUAL): December 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: balance; motor function; vestibular stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No