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

June 13, 2020 updated by: Aliya Ashraf Khan, National University of Science and Technology, Pakistan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 42200
        • Family Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: spastic Tongue Dysarthria
The purpose of gadget is to transmit the mechanical vibration waves to the brain of the subjects.
Device: Vibro Tactile Gadget
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Historical Treatment Measurement
Time Frame: At Enrollment
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
At Enrollment
Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language
Time Frame: At month 0, At month 03 and at month 06
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).
At month 0, At month 03 and at month 06
Parent Assessment Checklist
Time Frame: At month 0
A questionnaire is prepared for the child assessment by the parent.
At month 0
Parent Assessment Checklist
Time Frame: At month 3
A questionnaire is prepared for the child assessment by the parent.
At month 3
Parent Assessment Checklist
Time Frame: At month 6
A questionnaire is prepared for the child assessment by the parent.
At month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Assessment Checklist
Time Frame: At month 01
A questionnaire is prepared for the child assessment by the parent.
At month 01
Parent Assessment Checklist
Time Frame: At month 02
A questionnaire is prepared for the child assessment by the parent.
At month 02
Parent Assessment Checklist
Time Frame: At month 04
A questionnaire is prepared for the child assessment by the parent.
At month 04
Parent Assessment Checklist
Time Frame: At month 05
A questionnaire is prepared for the child assessment by the parent.
At month 05
Change in phonological disorders using TAAPU Test for assessment of articulation and phonology in urdu language
Time Frame: At month 01 and At month 02
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).
At month 01 and At month 02

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Science and Technology, Pakistan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Higher Education Commission (Pakistan)
Family Health Hospital Islamabad Pakistan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shahbaz K Ranjha, MPhil, Family Health Hospital Islamabad
  • Principal Investigator: Aliya A Khan, MS, National University of Science & Technology
  • Study Chair: Mohammad U Akram, Phd, National University of Science & Technology
  • Principal Investigator: Madeeha Nissar, MSc, Isra University islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NUST-FHH-HEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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