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

NCT04222049 | Completed DMC

• 1 other identifier: NUST-FHH-HEC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic Dysarthria

Keywords

Neurorehabilitation; Vibration; Neurotransmission; cerebral palsy; Dysarthria

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Parent Assessment Checklist

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

  At month 0

• Parent Assessment Checklist

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

  At month 3

• Parent Assessment Checklist

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

  At month 6

Secondary Outcomes (5)

• Parent Assessment Checklist

  At month 01

• Parent Assessment Checklist

  At month 02

• Parent Assessment Checklist

  At month 04

• Parent Assessment Checklist

  At month 05

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

  At month 01 and At month 02

Study Arms (1)

spastic Tongue Dysarthria

EXPERIMENTAL

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

Device: Vibro Tactile Gadget

Interventions

Vibro Tactile Gadget DEVICE

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.

spastic Tongue Dysarthria

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children diagnosed with following are excluded from our study
• Any speech disorders
• hearing impairments
• cleft palate
• tongue tie.

Sponsors & Collaborators

• National University of Science and Technology, Pakistan: lead
• Family Health Hospital Islamabad Pakistan: collaborator
• Higher Education Commission (Pakistan): collaborator

Study Sites (1)

Family Health Hospital

Islamabad, Federal, 42200, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy; Dysarthria

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahbaz K Ranjha, MPhil

  Family Health Hospital Islamabad

  STUDY DIRECTOR

• Aliya A Khan, MS

  National University of Science & Technology

  PRINCIPAL INVESTIGATOR

• Mohammad U Akram, Phd

  National University of Science & Technology

  STUDY CHAIR

• Madeeha Nissar, MSc

  Isra University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 9, 2020
• Study Start: July 15, 2019
• Primary Completion: May 12, 2020
• Study Completion: June 14, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the publication of the results data will be available for researchers who can benefit from it whenever they want.
• Access Criteria: Data will be shared to those researchers who want to continue research in the area

Locations

PA (1)