NCT05162092

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

November 16, 2021

Last Update Submit

December 16, 2021

Conditions

Keywords

vestibular stimulationmotor functionbalance

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

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.

Group A

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

Group B

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahwash Zulfiqar

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • bilal umer

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • anam naz

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahwash zulfiqar Khan, msptn

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
double (care provider ,outcome assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study participants will be randomized in two groups,conventional physiotherapy group and intervention group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 17, 2021

Study Start

July 4, 2021

Primary Completion

March 4, 2022

Study Completion

March 4, 2022

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations