Cerebral PalsyNCT04222049
Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria
A study testing Vibro Tactile Gadget in people with Cerebral Palsy and Spastic Dysarthria, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic Dysarthria
- What is being tested?
- Vibro Tactile Gadget
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2019to 14 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children having dysarthria due to cerebral Palsy
- Dysarthria due to damage in motor speech area/ broca area.
- Children having type Spastic Dysarthria
Who cannot join
- Children diagnosed with following are excluded from our study
- Any speech disorders
- hearing impairments
- cleft palate
- tongue tie.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cerebral Palsy, Spastic Dysarthria
- Being tested
- Vibro Tactile Gadget
- Keywords
- Neurorehabilitation, Vibration, Neurotransmission, cerebral palsy, Dysarthria
- Medical subject headings
- Cerebral Palsy, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibro Tactile GadgetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| spastic Tongue Dysarthria | Experimental | The purpose of gadget is to transmit the mechanical vibration waves to the brain of the subjects. Receives: Device: Vibro Tactile Gadget |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: At month 0, At month 03 and at month 06
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 0
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 3
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 6
Secondary outcomes (5)
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 01
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 02
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: At month 04
Parent Assessment Checklist
A questionnaire is prepared for the child assessment by the parent.
Measured: 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).
Measured: At month 01 and At month 02
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start15 Jul 2019
- Primary completion12 May 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Science and Technology, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)
- Responsible party
- Principal investigator, Aliya Ashraf Khan, National University of Science and Technology, Pakistan
- Investigators
- Shahbaz K Ranjha, MPhil, Study director, Family Health Hospital IslamabadAliya A Khan, MS, Principal investigator, National University of Science & TechnologyMohammad U Akram, Phd, Study chair, National University of Science & TechnologyMadeeha Nissar, MSc, Principal investigator, Isra University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222049
- Sponsor's protocol ID
- NUST-FHH-HEC
- Status last verified
- Jun 2020
- First submitted
- 1 Jan 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will show the data to other researchers once study is completed and results are published.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04222049
- Acronym / sponsor ID
- NUST-FHH-HEC
- Conditions
- Cerebral Palsy, Spastic Dysarthria
- Keywords
- Neurorehabilitation, Vibration, Neurotransmission, cerebral palsy, Dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National University of Science and Technology, PakistanUniversity, hospital or other
- Collaborators
- Family Health Hospital Islamabad Pakistan, Higher Education Commission (Pakistan)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spastic Tongue Dysarthria | Experimental | Device: Vibro Tactile GadgetThe purpose of gadget is to transmit the mechanical vibration waves to the brain of the subjects. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children having dysarthria due to cerebral Palsy
- Dysarthria due to damage in motor speech area/ broca area.
- Children having type Spastic Dysarthria
Key exclusion criteria (5 listed)
- Children diagnosed with following are excluded from our study
- Any speech disorders
- hearing impairments
- cleft palate
- tongue tie.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibro Tactile GadgetThe 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. | Device | spastic Tongue Dysarthria |
Primary outcome
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
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).
Parent Assessment Checklist
Time frame: At month 0
A questionnaire is prepared for the child assessment by the parent.
Parent Assessment Checklist
Time frame: At month 3
A questionnaire is prepared for the child assessment by the parent.
Parent Assessment Checklist
Time frame: At month 6
A questionnaire is prepared for the child assessment by the parent.
5 secondary outcomes
Parent Assessment Checklist
Time frame: At month 01
Parent Assessment Checklist
Time frame: At month 02
Parent Assessment Checklist
Time frame: At month 04
Parent Assessment Checklist
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Yes. we will show the data to other researchers once study is completed and results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibro Tactile Gadget in people with Cerebral Palsy and Spastic Dysarthria, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Historical Treatment Measurement (time frame: At Enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.