| CTRI Number |
CTRI/2025/09/094740 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Muscle Thickness and Quality in Stroke Survivors with Stiffness |
|
Scientific Title of Study
|
Muscle Thickness and Echogenicity in Post-Stroke Spasticity: A Comparative Study Between Early and Chronic Post-Stroke patients |
| 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 Nitesh Manohar Gonnade |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Physical Medicine & Rehabilitation (PMR)
Room No. 6, OPD – PMR
Jodhpur, Rajasthan – 342005
India
AIIMS JODHPUR ,PMR DEPARTMENT ,ROOM NO 6 OPD PMR,JODHPUR,RAJASTHAN ,342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9530199967 |
| Fax |
|
| Email |
drniteshgonnade9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Manohar Gonnade |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Physical Medicine & Rehabilitation (PMR)
Room No. 6, OPD – PMR
Jodhpur, Rajasthan – 342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9530199967 |
| Fax |
|
| Email |
drniteshgonnade9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Manohar Gonnade |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Physical Medicine & Rehabilitation (PMR)
Room No. 6, OPD – PMR
Jodhpur, Rajasthan – 342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9530199967 |
| Fax |
|
| Email |
drniteshgonnade9@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur
(Established by the Ministry of Health & Family Welfare, Government of India)
Basni Industrial Area, Phase–2
Jodhpur – 342005
Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur
(Established by the Ministry of Health & Family Welfare, Government of India)
Basni Industrial Area, Phase–2
Jodhpur – 342005
Rajasthan, India |
| Type of Sponsor |
Government medical college |
|
|
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 T K |
All India Institute of Medical Sciences, Jodhpur |
PMR Ddepartment, All India Institute of Medical Sciences, Jodhpur
(Established by the Ministry of Health & Family Welfare, Government of India)
Basni Industrial Area, Phase–2
Jodhpur – 342005
Rajasthan, India
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: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
78.00 Year(s) |
| Gender |
Both |
| Details |
First-ever ischemic or hemorrhagic stroke confirmed by imaging
more than months post-stroke at time of assessment
Clinically evident spasticity Modified Ashworth Scale more than one in at least one upper or lower limb
Ability to ambulate (with or without assistance)
Ability and willingness to provide informed consent |
|
| ExclusionCriteria |
| Details |
Cognitive impairment
Severe medical instability or pregnancy
History of phenol injection within past 2 years or botulinum toxin injection within past 3 months
Presence of intrathecal baclofen pump
Pre-existing neuromuscular or musculoskeletal disorders affecting limb function
Uncontrolled pain or orthopedic deformity interfering with assessment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in ultrasound-measured muscle thickness and echogenicity |
cross sectional study ,only one point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between ultrasound parameters & spasticity severity |
Obervational study ,only one point baseline |
| Correlation between ultrasound parameters & motor impairment |
Obervational study ,only one point baseline |
Association between ultrasound parameters & functional performance
Grip Strength measured with handheld dynamometer in kilograms, Timed Up & Go recorded in seconds, 6 Minute Walk Test measured in meters
Within-subject comparison of muscle thickness & echogenicity between paretic & non-paretic limbs
Modified Heckmatt Scale Grades 1 to 4 |
Obervational study ,only one point baseline |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Post-stroke spasticity leads to stiffness and weakness in the affected limbs, often resulting in difficulty walking and using the arm. This study aims to understand how muscle thickness and muscle quality (echogenicity) change over time after stroke. Using ultrasound, we will measure selected upper and lower limb muscles in two groups of stroke survivors: early stage (3–6 months) and chronic stage (>6 months). We will also record spasticity severity, motor function, grip strength, walking speed, and balance. The goal is to find whether muscle changes are worse in chronic stroke and how they relate to functional performance. Results may help design better rehabilitation programs and use ultrasound as a simple bedside tool to monitor recovery. |