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Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria

Primary Purpose

Cerebral Palsy, Spastic Dysarthria

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Vibro Tactile Gadget

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Neurorehabilitation, Vibration, Neurotransmission, cerebral palsy, Dysarthria

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

children having dysarthria due to cerebral Palsy
Dysarthria due to damage in motor speech area/ broca area.
Children having type Spastic Dysarthria

Exclusion Criteria:

Children diagnosed with following are excluded from our study

Any speech disorders
hearing impairments
cleft palate
tongue tie.

Sites / Locations

Family Health Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spastic Tongue Dysarthria

Arm Description

The purpose of gadget is to transmit the mechanical vibration waves to the brain of the subjects.

Outcomes

Primary Outcome Measures

Child Historical Treatment Measurement

Socio demographic and Health related data is collected so that that efficacy of treatment under study can be calculated w.r.t pre treatment assessments

Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language

Scores for fronting, stopping, phonological disorders, final consonant deletion, Nasal assimilation and de-palatalization is calculated pre and post assessment through TAAPU(Test for assessment of articulation and phonology in urdu language).

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Secondary Outcome Measures

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Parent Assessment Checklist

A questionnaire is prepared for the child assessment by the parent.

Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language

Full Information

NCT ID

NCT04222049

First Posted

January 1, 2020

Last Updated

June 13, 2020

Sponsor

National University of Science and Technology, Pakistan

Collaborators

Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)

1. Study Identification

Unique Protocol Identification Number

NCT04222049

Brief Title

Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria

Official Title

Application of Vibration Wave Therapy to the Speech of Children Suffering From Cerebral Palsy and Dysarthria Using Neuro Transmission Cognitive Theory: Single Group Experimental Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

May 12, 2020 (Actual)

Study Completion Date

June 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Science and Technology, Pakistan

Collaborators

Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Vibration therapy is the widely used in many neurological disorders for different type of problems. Recently, it is being used by researchers for the betterment of motor disorders and muscle movements of the cerebral palsy patients and significant results are obtained. Investigators are conducting this research to explore that whether this therapy can have some effect on the Spastic Tongue Dysarthria of the Cerebral Palsy patients.

Detailed Description

This study is going to be conducted in collaboration with Shahbaz Khalid Ranjha , Speech Language Pathologist, Family Health Hospital Islamabad who is the main person for the idea of the study and National University of Science & Technology. This study is funded by Higher Education Commission of Pakistan. Recruitment and Intervention Work will be carried out in Family Health Hospital. Special device is being designed for transmission of Vibration waves in Lab of the university. The device is capable to transmit vibration waves to the patient. Urdu language phonological and articulation test(TAAPU) will be used for assessment as it is specially designed for Urdu language population which will be the main focus. Investigators have defined speech parameters for analysis which will be collected before application of intervention, after 3 months and then at the end of the study. Parents assessment will be collected and noted through out the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Spastic Dysarthria

Keywords

Neurorehabilitation, Vibration, Neurotransmission, cerebral palsy, Dysarthria

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

spastic Tongue Dysarthria

Arm Type

Experimental

Arm Description

The purpose of gadget is to transmit the mechanical vibration waves to the brain of the subjects.

Intervention Type

Device

Intervention Name(s)

Vibro Tactile Gadget

Intervention Description

The concept is to apply vibro tactile gadget to different nerve points which when applied transmit waves to the focused parts of brain which will result in blood flow and activation of dead cells. As a result some disabled part of the body because of those dead cells can show improvement.

Primary Outcome Measure Information:

Title

Child Historical Treatment Measurement

Description

Socio demographic and Health related data is collected so that that efficacy of treatment under study can be calculated w.r.t pre treatment assessments

Time Frame

At Enrollment

Title

Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language

Description

Time Frame

At month 0, At month 03 and at month 06

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 0

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 3

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 6

Secondary Outcome Measure Information:

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 01

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 02

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 04

Title

Parent Assessment Checklist

Description

A questionnaire is prepared for the child assessment by the parent.

Time Frame

At month 05

Title

Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language

Description

Time Frame

At month 01 and At month 02

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: children having dysarthria due to cerebral Palsy Dysarthria due to damage in motor speech area/ broca area. Children having type Spastic Dysarthria Exclusion Criteria: Children diagnosed with following are excluded from our study Any speech disorders hearing impairments cleft palate tongue tie.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shahbaz K Ranjha, MPhil

Organizational Affiliation

Family Health Hospital Islamabad

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Aliya A Khan, MS

Organizational Affiliation

National University of Science & Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad U Akram, Phd

Organizational Affiliation

National University of Science & Technology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Madeeha Nissar, MSc

Organizational Affiliation

Isra University Islamabad

Official's Role

Principal Investigator

Facility Information:

Facility Name

Family Health Hospital

City

Islamabad

State/Province

Federal

ZIP/Postal Code

42200

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

we will show the data to other researchers once study is completed and results are published.

IPD Sharing Time Frame

After the publication of the results data will be available for researchers who can benefit from it whenever they want.

IPD Sharing Access Criteria

Data will be shared to those researchers who want to continue research in the area

Learn more about this trial

Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria

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