Effect of Vestibular Stimulation on Motor Proficiency and... | NCT06197750

Studies
Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome

NCT06197750

Sponsor

Riphah International University

Status

Completed

Last Update Posted

Jan 9, 2024Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Vestibular System Disorder

Interventions

Vestibular stimulation
General strengthening exercises

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Nov 16, 2022Actual

Completion Date

Dec 16, 2022Actual

First Submitted Date

Feb 5, 2023

First Submission Date that Met QC Criteria

Dec 26, 2023

First Posted Date

Jan 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2023

Last Update Posted Date

Jan 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vestibular stimulation	Other	Vestibular stimulation by swing	Vestibular stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:• Down syndrome

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fareeha Kausar, PP-DPT	Riphah International University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabia Razzaq		Sialkot	Punjab Province	51480	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015837	Vestibular Diseases
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D001925	Brain Damage, Chronic

Browse Leaves

Not provided

Browse Branches

Not provided