| CTRI Number |
CTRI/2024/04/066161 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
WILL TRANSCUTANEOUS AURICULAR VAGAL NERVE STIMULATION ON MOTOR AND COGNATIVE PERFORMANC WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER EFFECTIVE |
|
Scientific Title of Study
|
EFFECT OF TRANSCUTANEOUS AURICULAR VAGAL NERVE STIMULATION AND BEHAVIOURAL PARENT TRAINING ON MOTOR AND COGNITIVE PERFORMANCE WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Mutkalwar |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy college |
| Address |
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research (deemed to be), sawangi (meghe) wardha
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research (deemed to be), sawangi (meghe) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8390539360 |
| Fax |
|
| Email |
rohitmutkalwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy college |
| Address |
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research(deemed to be), sawangi (meghe) wardha
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research (deemed to be), sawangi (meghe) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghumahanti Raghuveer |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy college |
| Address |
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research (Deemed to be), sawangi (meghe) wardha
Department of Neuro Physiotherapy Ravi nair physiotherapy college datta meghe institute of higher education and research(Deemed to be), sawangi (meghe) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ravi nair physiotherapy college datta meghe institute of higher education and research (Deemed to be), sawangi (meghe) wardha, pin code-442001, maharashtra |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi nair physiotherapy college datta meghe institute of higher education and research sawangi (meghe) wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Mutkalwar |
Acharya Vinoba Bhave Rural Hospital |
Department of Pediatric, Pediatric OPD, Pediatric wards Ravi Nair physiotherapy college Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
8390539360
rohitmutkalwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Datta Meghe Institute of Higher Education and Research(deemed to be) Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Parental Behavioural Therapy
2. Sensory Integration Therapy
|
The duration of the intervention is 4 weeks. Play-Based Activities- Therapists design playful activities that involve various sensory experiences to challenge the childs sensory processing abilities. These activities may include playing with swings, trampolines, large balls, and other equipment that provide sensory input for the children. |
| Intervention |
Transcutaneous auricular vagal nerve stimulation (taVNS) |
The duration of the intervention is 4 weeks.
Position of child- sitting/supine
Therapist position- beside the patient
Method- Children with ADHD having cognative and motor imparements are selected then the clip of the taVNS is applied on Cymba Concha of the ear for 10min per day.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with mild & moderate ADHD.
2. Children with inattentive & hyperactive impulsive.
3. Age group- 6-17years
4. Both genders
5. Children who are able to actively participate in a rehabilitation program, including engagement in physical activities
|
|
| ExclusionCriteria |
| Details |
1. Recent head injury.
2. Any operative neurological disorder.
3. Musculoskeletal disorder.
4. Multiple gestations.
5. Severe ADHD.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vanderbilt ADHD Diagnostic Parent Rating Scale |
baseline data will be taken and data will be analyzed at end of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. SNAP-IV rating scale
2.Child behaviour checklist scoring scale.
|
baseline data will be taken and data will be analyzed at end of the treatment |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to rigorously investigate the impact of a transcutaneous auricular vagal nerve stimulation in children with Attention-deficit hyperactivity disorder who concurrently experience attention, behaviour, motor and cognitive impairments. By systematically assessing the effects of the intervention on both motor and cognitive domains, the study aims to provide taVNS. |