| 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
|
|
|
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
|
|
|
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. |