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CTRI Number  CTRI/2024/03/064110 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
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   Effectiveness of extracorporeal shockwave therapy in treating spasticity in chronic stroke survivors 
Scientific Title of Study   Effect of extracorporeal shockwave therapy on spasticity in chronic 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  SARIYA AZAM 
Designation  PG scholar 
Affiliation  Amity Institute of health allied sciences  
Address  F1 block lower ground floor ,Amity institute of health allied sciences, Amity university,,Uttar Pradesh Sector 125 Noida 201301 India

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8800155976  
Fax    
Email  azamsariya88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meena Gupta  
Designation  Assistant Professor  
Affiliation  Amity Institute of health allied sciences 
Address  Room no Lg05, F1 block lower ground floor ,Amity institute of health allied sciences, Amity university, Noida, Uttar Pradesh r

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9717281491  
Fax    
Email  mgupta9@amity.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Meena Gupta  
Designation  Assistant Professor  
Affiliation  Amity Institute of health allied sciences 
Address  F-1 block lower ground floor Amity institute of health allied sciences, amity university ,Noida Uttar Pradesh, sector 125

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9717281491  
Fax    
Email  mgupta9@amity.edu  
 
Source of Monetary or Material Support  
Neuro rehab- Dr Krishan Mohan physiotherapy clinic Room no 101 , C-74, sector 100, Noida Gautam Buddha Nagar, Uttar Pradesh  
 
Primary Sponsor  
Name  Sariya Azam  
Address  Amity Institute of health allied sciences, amity university, ,Noida, Uttar Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishan Mohan   Neuro rehab- Dr Krishan Mohan physiotherapy clinic  C-74 Block C sector 100 Noida
Gautam Buddha Nagar
UTTAR PRADESH 
9899938240

drkrishanmohanpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional NTCC committee, Amity Institute of healthAllied Sciences, Amity University Uttar Pradesh  Approved 
Neuro Rehab- Dr. Krishan Mohan Physiotherapy Clinic  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional therapy   ROM exercises, stretching, resistance and balance exercises, gait and functional training For 2 months 
Comparator Agent  Extracorporeal Shockwave therapy   ROM exercises, stretching, resistance and balance exercises, gait , shockwave therapy for 2 months  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals who have experienced a stroke
- Age range (e.g., 30-75 years old)
- Medically stable participants
- Presence of spasticity
- Participants willing to engage in extracorporeal shockwave therapy 
 
ExclusionCriteria 
Details  Severe cognitive impairments that hinder participation - Uncontrolled medical conditions
- Pre-existing shoulder injuries or surgeries
- Inability to provide informed consent
- Participation in other conflicting rehabilitation programs 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce spasticity   8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To increase range of motion and improve quality of life   8 weeks  
 
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)   24/03/2024 
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="0"
Months="2"
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  
the phenomenon of spasticity following a stroke and Extracorporeal Shockwave Therapy (ESWT) as a potential treatment option for reducing spasticity in stroke patients. Spasticity is described as a motor disorder resulting from hyperexcitability of the stretch reflex, contributing to functional limitations and negatively impacting recovery.

ESWT is a series of high-energy mechanical waves with characteristics such as pressure, rapid pressure increase, and short action cycle. It is categorised into focused (fESWT) and radial (rESWT) types, each having different penetration depths and applications. The study emphasises ESWT’s ability to induce nitric oxide synthesis, reduce motor neuron excitability, modulate nerve conduction, and affect muscle and soft tissue.

Several studies and findings are referenced to support the claim that ESWT may alleviate limb spasticity after a stroke through mechanisms such as increased nitric oxide production, reduced motor neuron excitability, and modulation of nerve conduction. The text also mentions the impact of ESWT on muscle and soft tissue, suggesting improvements in joint mobility and muscle properties.

The need for further research on the effects of shockwave therapy on spasticity in stroke patients is highlighted. The potential benefits include offering an alternative treatment option, a non-invasive approach, and potentially improving rehabilitation outcomes for stroke survivors.

The study’s aim is stated as determining whether shockwave therapy can effectively reduce spasticity in chronic stroke patients. The objective is to examine if stroke patients receiving shockwave therapy show better mobility and functional capacities, with specific measurements of muscle tone and range of motion. Two hypotheses are presented: a null hypothesis suggesting no significant difference in spasticity reduction with shockwave therapy and an alternate hypothesis proposing a statistically significant difference.

Inclusion criteria for potential study participants are outlined, including a history of stroke, a specified age range, medical stability, presence of spasticity, and willingness to engage in shockwave therapy. Exclusion criteria involve severe cognitive impairments, uncontrolled medical conditions, pre-existing shoulder injuries or surgeries, inability to provide informed consent, and participation in conflicting rehabilitation programs.

The dependent variable in the study is the level of spasticity, while the independent variable is the application of extracorporeal shockwave therapy. The text suggests using the Modified Ashworth Scale and possibly other tools to measure and evaluate the effects of shockwave therapy on spasticity.
 
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