NCT06197750

Brief Summary

This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period. Data will be then analyzed by using SPSS windows version 25

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

February 5, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Vestibular stimulation (VeS)Hypotonic cerebral palsy

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale

    Improvement in balance from baseline among children with Down syndrome

    16 WEEKS

  • motor proficiency

    Improvement in motor proficiency from baseline among children with Down syndrome

    16 WEEKS

Study Arms (2)

Vestibular stimulation

EXPERIMENTAL

Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and

Other: Vestibular stimulation

general strengthening exercises

ACTIVE COMPARATOR

group B will receive general strengthening exercises of whole body for same time period.

Other: General strengthening exercises

Interventions

Vestibular stimulation by swing

Vestibular stimulation

General strengthening exercises

general strengthening exercises

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to 11 years
  • Having no other medical history (6)

You may not qualify if:

  • Visual impairment
  • Patient with hearing impairment
  • Patient with poor cognition (6, 8)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabia Razzaq

Sialkot, Punjab Province, 51480, Pakistan

Location

MeSH Terms

Conditions

Vestibular DiseasesCerebral Palsy

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fareeha Kausar, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

January 9, 2024

Study Start

June 1, 2022

Primary Completion

November 16, 2022

Study Completion

December 16, 2022

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations