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

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: Completed
• Conditions: Cerebral Palsy; Spastic Dysarthria
• Intervention / Treatment: Device: Vibro Tactile Gadget

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: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Assessment Checklist	A questionnaire is prepared for the child assessment by the parent.	At month 01
Parent Assessment Checklist	A questionnaire is prepared for the child assessment by the parent.	At month 02
Parent Assessment Checklist	A questionnaire is prepared for the child assessment by the parent.	At month 04
Parent Assessment Checklist	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	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

• Sponsor: National University of Science and Technology, Pakistan
• Collaborators: Higher Education Commission (Pakistan); Family Health Hospital Islamabad Pakistan
• Investigators: 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

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): June 14, 2020

Study Registration Dates

• First Submitted: January 1, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Vibration; cerebral palsy; Neurorehabilitation; Dysarthria; Neurotransmission
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Language Disorders; Communication Disorders; Muscle Hypertonia; Speech Disorders; Articulation Disorders; Cerebral Palsy; Paralysis; Muscle Spasticity; Dysarthria
• Other Study ID 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