| CTRI Number |
CTRI/2024/05/067088 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral
Other (Specify) [Rehabilitation] |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Context specific guidelines for stroke rehabilitation in India |
|
Scientific Title of Study
|
Implementation of contextualized clinical practice guidelines for motor rehabilitation post-stroke in India- the CLAIM INDIA study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dorcas BC Gandhi |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Room No 196 department of Neurology CMC Brown Road Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
7087964999 |
| Fax |
|
| Email |
dorcasattend@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dorcas BC Gandhi |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Room No 196 Dept of Neurology CMC Brown Road Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
7087964999 |
| Fax |
|
| Email |
dorcasattend@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dorcas BC Gandhi |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Room No 196 Department of Neurology CMC Brown Road Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
7087964999 |
| Fax |
|
| Email |
dorcasattend@gmail.com |
|
|
Source of Monetary or Material Support
|
| Society of Indian Physiotherapists Amar Jyoti Institute of Physiotherapy Vikas Marg Karkardooma New Delhi 110092 India |
|
|
Primary Sponsor
|
| Name |
Dorcas BC Gandhi |
| Address |
Room no 196 Dept of Neurology Christian Medical College and Hospital Ludhiana Punjab 141008 India |
| Type of Sponsor |
Other [Self] |
|
|
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 John M Solomon |
Manipal Academy of Higher Education |
Tiger Circle Road, Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA |
9945670671
john.solomon@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Contextualized Clinical Practice Guidelines for motor rehabilitation post-stroke |
Top recommendations that have been proven to be most feasible and relevant to motor rehabilitation post-stroke that are contextualized to Indian setting in Phases 1 and 2, will be identified via a qualitative design. The intervention will comprise of multicomponent strategies that will enable rehabilitation professionals to implement the selected recommendations in their clinical practice. The intervention will include educational modules, 2 workshops, periodic audit of clinical practice with feedback and fidelity testing. The intervention will continue for 3 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
For Phase 1: representatives from different Indian zones, rural/urban, public/private hospitals):
if they have been practicing stroke rehabilitation as Neurologists/Physiatrists/PTs/OTs/ rehabilitation nurses/Social workers in India for a minimum of 10 years.
Persons with lived experience (PwLEs) will be included in the panel after due voluntary informed consent if they have had any type of stroke in the past 5 years and have availed rehabilitation service in India
For Phase 2: Stroke experts in motor rehabilitation with clinical experience in India for a minimum of 10 years (equal balance between PTs, OTs, Neurologists, Physiatrists)
Stroke researchers of motor rehabilitation working in India for a minimum of 10 years
PwLE of stroke (subacute or chronic phases of stroke), representatives from stroke support organization in India
Hospital and local administrators
Local Policy advisors
Social workers/community health worker/ASHA
For Phase 3: for stroke rehab providers
PTs employed in the SU at the 2 tertiary hospitals with responsibility of assessing, planning and delivering motor rehabilitation post-stroke
OTs employed in the SU at the 2 tertiary hospitals with responsibility of assessing, planning and delivering motor rehabilitation post-stroke
Inclusion criteria for Stroke PwLE
Depending on the recommendation prioritized
|
|
| ExclusionCriteria |
| Details |
Those unwilling or not fulfilling selection criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reach effectiveness adoption implementation sustainability the REAIM outcome |
16th and 24th week post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This 3 phased mixed methods study is aimed at studying the impact of clinical and implementation outcomes of a multi-component intervention on contextualized motor rehabilitation Clinical Practice Guidelines (CPGs) for stroke rehabilitation in India. Phase 1 will include a qualitative (focus group discussions), co-design method to contextualize existing stroke rehabilitation guidelines for the Indian context, following the methodology for contextualization provided by Grimmer etal. Phase 2 will include a 4-phased qualitative design (survey) to prioritize top recommendations from contextualized CPGs developed in Phase 1 that are most feasible and relevant to be implemented. This phase will also be co-design and based on a prioritization model followed in Australia by Lynch etal. Phase 3 will follow the Hybrid-2 implementation study design to study the impact of implementing the prioritized recommendations from phase-2 across 2 tertiary hospitals in India. Outcomes will be: the RE-AIM i.e. Reach, Effectiveness, adoption, implementation & maintenance of the intervention/prioritized recommendations. |