| CTRI Number |
CTRI/2025/12/098560 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Stroke Recovery: What Improves During Hospital Rehabilitation? |
|
Scientific Title of Study
|
Prospective Observational Study on Quality of Life, Disability, Upper Limb Function, and Gait Parameters in Stroke Patients Following Inpatient Rehabilitation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of
Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Phase 2 Basni
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7907102168 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of
Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Phase 2 Basni
RAJASTHAN
342005
India |
| Phone |
7907102168 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Gaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of
Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Phase 2 Basni
RAJASTHAN
342005
India |
| Phone |
7907102168 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS jodhpur rajasthan india |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
AIIMS jodhpur rajasthan india |
| 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 |
| abins tk |
All India Institute of Medical Sciences (AIIMS) in Jodhpur |
Room no 15 ,Department of PMR,All India Institute of Medical Sciences (AIIMS), Basni, Jodhpur, Rajasthan, 342005
Jodhpur
RAJASTHAN |
9947332918
abiabin11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than 18 years with recent stoke less than 1 year old ischemic or hemorrhagic stroke.
Medically stable and admitted for inpatient rehabilitation.
Able to provide informed consent and participate in assessments.
|
|
| ExclusionCriteria |
| Details |
Pre-stroke mRS more than 4
Non-ambulatory status prior to stroke.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in health-related quality of life (HRQoL) measured by the EQ-5D-5L index from admission (baseline) to 24 weeks post-discharge. |
Change in health-related quality of life (HRQoL) measured by the EQ-5D-5L index from admission (baseline) to 24 weeks post-discharge.6, 12, and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the change in functional disability using the Modified Rankin Scale (mRS)
2. To evaluate the change in functional independence level by Barthel Index (BI).
3. To measure upper limb motor recovery using the Fugl-Meyer Assessment (Upper Limb subscore).
4. To analyze gait improvements using spatiotemporal analysis and the Timed Up and Go (TUG) test.
5. To assess psychological status using the Hospital Anxiety and Depression Scale (HADS).
|
6, 12, and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
20/12/2025 |
| 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 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 prospective observational study aims to evaluate changes in quality of life, functional independence, disability, upper limb motor recovery, gait performance, and psychological status among stroke patients undergoing inpatient rehabilitation. Adult patients with recent ischemic or hemorrhagic stroke will be assessed at admission, discharge, and at 6, 12, and 24 weeks after discharge using validated tools such as the EQ5D5L, Barthel Index, Modified Rankin Scale, Fugl Meyer Upper Limb, Timed Up and Go test, and HADS. The primary hypothesis is that structured inpatient rehabilitation significantly improves health related quality of life from baseline to 24 weeks post discharge. |