| CTRI Number |
CTRI/2024/08/073129 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Trial of community based stroke rehabilitation on activities of daily living of stoke survivors |
|
Scientific Title of Study
|
Impact of community- based stroke rehabilitation on activities of daily life of stroke survivors – a Quasi-experimental 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 |
Dr Manjusha V Nair |
| Designation |
MD resident |
| Affiliation |
Amrita School of Medicine, Kochi, Kerala |
| Address |
MD resident, Department of Community Medicine, C-Block, 7th floor, Room No: 12
Amrita School of Medicine, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8547658721 |
| Fax |
|
| Email |
vnmanjusha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswathy S |
| Designation |
Professor and H O D |
| Affiliation |
Amrita School of Medicine, Kochi, Kerala |
| Address |
Department of Community Medicine,C-Block, 7th floor, Room No: 1
Amrita School of Medicine, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8547658721 |
| Fax |
|
| Email |
draswathygopan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha V Nair |
| Designation |
MD resident |
| Affiliation |
Amrita School of Medicine, Kochi, Kerala |
| Address |
Department of Community Medicine, C-Block, 7th floor, Room No: 12
Amrita School of Medicine, Ponekkara, Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8547658721 |
| Fax |
|
| Email |
vnmanjusha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences,Ponekkara P.O, Kochi, Kerala, India - 682 041 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Manjusha V Nair |
Cheranalloor and Pizhala and Varappuzha |
Department of Community Medicine, C-Block,7th floor, Room No:12, Amrita Institute of Medical Sciences, Ponekkara P.O., Kochi, Kerala- 682 041
Ernakulam
KERALA |
8547658721
vnmanjusha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| DMO OFFICE |
Approved |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercises for stroke survivors |
This study is conducted for patients having stroke for less than 2 years with residual disability. Exercises are classified as range of motion exercises, strengthening exercises and gait exercises. Exercises are advised based on the power of upper limb and lower limb. For a patient with power 0 or 1, passive exercise will be done with the help of a caregiver. For power 2 and 3, active assisted exercises will be advised where the patient will initiate the exercise with support by the caregiver. For power 4 and 5, active exercises will be prescribed. Initially, these exercises will be explained and taught to the patients. Then, the patients will be followed up for 3 months. At the end of this period, they will be re-evaluated for any improvement in their strength. Total duration of study will be 6 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Ischemic/ haemorrhagic stroke
|
|
| ExclusionCriteria |
| Details |
Not willing for follow-up rehabilitation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved activities of daily living |
0 months & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine change in quality of life |
0 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2024 |
| 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="6"
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
|
Stroke is an emerging public health problem. It is a major cause of mortality, morbidity including significant disability with the greatest burden being in low and middle income countries. Stroke is the second most common cause of mortality after coronary artery disease causing nearly 6 million deaths annually among the 17 million people affected. India is witnessing a pattern of epidemiological transition, where the burden of communicable diseases is declining, while the burden of non-communicable diseases, especially stroke, is increasing. Globally, several studies have been done to assess the effect of rehabilitation in stroke by the help of family members or other non-family caregivers like home nurses. But these studies do not show any change in dependency or death or activities of daily living of stroke patients. Therefore, it is essential to identify and adapt new strategies for rehabilitation for stroke. Giving them physical and mental support at their homes by trained health workers may increase the adherence to rehabilitation and subsequent improvement in activities of daily life and quality of life. So, the primary focus of this study is the follow-up rehabilitation provided in the patients’ homes by trained health workers with the support of family members. |