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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04222049
Other study ID # NUST-FHH-HEC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date June 14, 2020

Study information

Verified date June 2020
Source National University of Science and Technology, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 14, 2020
Est. primary completion date May 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 8 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Pakistan Family Health Hospital Islamabad Federal

Sponsors (3)

Lead Sponsor Collaborator
National University of Science and Technology, Pakistan Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At Enrollment
Primary 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). At month 0, At month 03 and at month 06
Primary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 0
Primary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 3
Primary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 6
Secondary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 01
Secondary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 02
Secondary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 04
Secondary Parent Assessment Checklist A questionnaire is prepared for the child assessment by the parent. At month 05
Secondary 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). At month 01 and At month 02
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