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CompletedNCT04222049Updated Jun 16, 2020

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

An interventional study of Vibro Tactile Gadget in Cerebral Palsy and Spastic Dysarthria, sponsored by National University of Science and Technology, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by National University of Science and Technology, Pakistan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
4 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Spastic Dysarthria

Keywords

  • Neurorehabilitation
  • Vibration
  • Neurotransmission
  • cerebral palsy
  • Dysarthria
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's enrollment of 12 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

National University of Science and Technology, Pakistan is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Children diagnosed with following are excluded from our study

  • Any speech disorders
  • hearing impairments
  • cleft palate
  • tongue tie.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • DeviceVibro 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At Enrollment

  2. 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).

    Time frame: At month 0, At month 03 and at month 06

  3. Parent Assessment Checklist

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

    Time frame: At month 0

  4. Parent Assessment Checklist

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

    Time frame: At month 3

  5. Parent Assessment Checklist

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

    Time frame: At month 6

Secondary outcomes

  1. Parent Assessment Checklist

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

    Time frame: At month 01

  2. Parent Assessment Checklist

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

    Time frame: At month 02

  3. Parent Assessment Checklist

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

    Time frame: At month 04

  4. Parent Assessment Checklist

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

    Time frame: At month 05

  5. 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).

    Time frame: At month 01 and At month 02

07

Study locations

1 site
  • Family Health Hospital
    Islamabad, Federal 42200, Pakistan
08

References and documents

Individual participant data

Plan to share: Yes — we will show the data to other researchers once study is completed and results are published.

Supporting information: Study protocol, Statistical analysis plan, 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04222049
Lead sponsor
National University of Science and Technology, Pakistan
Collaborators
Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)
Responsible party
Aliya Ashraf Khan (principal investigator, National University of Science and Technology, Pakistan) — Principal investigator
First posted
Jan 9, 2020
Start date
Jul 15, 2019
Primary completion
May 12, 2020
Completion
Jun 14, 2020
Last update
Jun 16, 2020

Study contacts

Shahbaz K Ranjha, MPhil
study director · Family Health Hospital Islamabad
Aliya A Khan, MS
principal investigator · National University of Science & Technology
Mohammad U Akram, Phd
study chair · National University of Science & Technology
Madeeha Nissar, MSc
principal investigator · Isra University Islamabad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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