| CTRI Number |
CTRI/2024/04/066354 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised control trial on Effects of TASKS Rehabilitation Protocol in children with Guillain Barre syndrome |
|
Scientific Title of Study
|
Effect of Paediatric Rehabilitation Using TASKS Protocol on Respiratory and Neuromuscular Impairment in Children With Guillain Barre Syndrome: 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 |
Pratiksha Warghat |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU), Wardha |
| Address |
Room No.1, 1st Floor, Department of Paedaitrics Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7028652866 |
| Fax |
|
| Email |
pratikshawarghat1118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha |
| Designation |
Principal |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Room No.2, 1st Floor, Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9665682103 |
| Fax |
|
| Email |
umale.neha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratiksha Warghat |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Room No.1, 1st Floor, Department of Paedaitrics Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7028652866 |
| Fax |
|
| Email |
pratikshawarghat1118@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research,Sawangi Meghe ,Wardha,442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research |
| Address |
Ravi Nair Physiotherapy College ,Datta Meghe Institute of Higher Education And Research,Sawangi Meghe ,Wardha,442001 |
| 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 Sharath Hullumani |
Department of Paedaitric |
Ward no 17, 2ND Floor, Department of Paediatrics , Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha-442001
Wardha
MAHARASHTRA |
9964066927
sharathhullumani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (DU) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional Therapy |
Passive ROM exercise,
Manual Chest percussion and vibration, positioning.
Daily for 4 weeks |
| Intervention |
TASKS Protocol |
manual airway clearance techniques, NDT, Sensory integration techniques, hand task performance, fatigue coping strategies, breathing techniques
Daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 4-14 years diagnosed with Acute Motor Axonal Neuropathy variant
of GBS based on established clinical and electrophysiological criteria.
2. Both male and female
3. Children who are able to actively participate in a rehabilitation program, including
engagement in physical activities. |
|
| ExclusionCriteria |
| Details |
1. severe respiratory complication with immediate intensive medical intervention or mechanical intervention.
2. Severe neuromuscular impairment
3. Children with severe coexisting neurological conditions.
4. Unstable medical condition.
5. Previous Participation in similar trials to avoid confounding effects from previous interventions.
6. Other severe comorbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a)Erasmus GBS Respiratory Insufficiency Score (EGRIS)
b)Guillain Barre Syndrome Disability Score |
Base line and at 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Evaluation of Disability Inventory(PEDI) |
Base line & at 4th week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/05/2024 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sharathhullumani@gmail.com].
- For how long will this data be available start date provided 13-03-2024 and end date provided 13-03-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of this study is to systematically investigate and compare the impact of paediatric rehabilitation employing the TASKS protocol versus conventional rehabilitation methods on respiratory and neuromuscular impairments in children diagnosed with Guillain-Barré Syndrome (GBS). |