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CTRI Number  CTRI/2025/12/099705 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 21/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of exercise therapy and blood flow restriction therapy on muscle regeneration in patients with neuromotor injuries 
Scientific Title of Study   MYOGENESIS STIMULATOR- Investigating The Difference In Molecular Mechanisms Of Improvement Following Regular Exercise Programme And Blood Flow Restriction Exercise For Patients With Neuromotor Injuries. 
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 Logaseni 
Designation  Postgraduate 
Affiliation  Saveetha medical college hospital 
Address  ward no.120, 1st floor, Department of paediatrics,saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  8248708463  
Fax    
Email  logaseni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lal Devayanivasudevan Nair 
Designation  Professor 
Affiliation  Saveetha medical college hospital 
Address  ward no.120, 1st floor, Department of paediatrics,saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrLogaseni 
Designation  Postgraduate 
Affiliation  Saveetha medical college hospital 
Address  ward no.120, 1st floor, Department of paediatrics,saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai


TAMIL NADU
602105
India 
Phone  8248708463  
Fax    
Email  logaseni@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Saveetha medical college hospital 
Address  162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105 
Type of Sponsor  Private medical college 
 
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 
DrLogaseni  Saveetha medical college hospital  ward number 120,1st floor, Department of paedaitrics, Saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105
Chennai
TAMIL NADU 
8248708463

logaseni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G737||Myopathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional exercise rehabilitation programme  Participants will undergo standard physiotherapy-based exercise rehabilitation including stretching, upper-limb and lower-limb strengthening exercises. Sessions will be conducted for 10–20 minutes, 2–3 times per week for a period of 4 weeks. 
Intervention  Myogenesis stimulator with blood flow restriction (BFR)–assisted exercise therapy  Blood flow restriction will be applied using an inflatable pneumatic cuff placed over the intended muscle group. Exercise will be performed with low-load resistance (20–40% of one-repetition maximum based on muscle power grading). Each session will last 10–20 minutes, conducted 2–3 times per week for 4 weeks of period. Continuous restriction will be applied for up to 10 minutes per exercise. Vital signs including heart rate, blood pressure, oxygen saturation, and distal limb perfusion will be monitored during and after the procedure. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Patients diagnosed with neuromotor injuries,
Presence of muscle weakness or reduced muscle mass,
Age-appropriate patients eligible for exercise rehabilitation,
Willingness to participate and provide written informed consent (parental consent where applicable) 
 
ExclusionCriteria 
Details  Unstable medical conditions contraindicating exercise therapy,
Severe cardiovascular or peripheral vascular disease
Local limb infection, open wounds, or contraindications to BFR,
Patients unwilling or unable to comply with study procedures 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in molecular markers of muscle regeneration (miR-27b and Myogenic Regulatory Factor-4)  baseline, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in skeletal muscle mass (fat-free mass)  Baseline and post-intervention of 3 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/01/2026 
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="3"
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 study is a single-centre, parallel-group randomized controlled trial designed to compare the effects of conventional exercise rehabilitation and blood flow restriction–assisted myogenesis stimulation on muscle regeneration in patients with neuromotor injuries. Neuromotor disorders are commonly associated with muscle weakness and loss of skeletal muscle mass, leading to functional impairment and reduced quality of life. Emerging rehabilitation strategies such as blood flow restriction training may enhance muscle adaptation through molecular mechanisms even at low exercise intensities.Eligible participants will be randomly allocated into two groups: one group will receive standard exercise rehabilitation, while the other will undergo blood flow restriction–assisted exercise using a myogenesis stimulator. Interventions will be administered for 10–20 minutes per session, 2–3 times per week, over a period of 1–3 weeks. Safety monitoring including vital signs and limb perfusion will be carried out throughout the intervention.The primary outcome measure is the change in molecular markers of muscle regeneration, specifically miR-27b and myogenic regulatory factor-4 (MRF-4), assessed before and after the intervention. Secondary outcomes include changes in skeletal muscle mass measured by DEXA scan, limb circumference, muscle tone, and muscle power. The study aims to generate preliminary evidence on the molecular and functional effects of blood flow restriction–assisted exercise compared with conventional rehabilitation in patients with neuromotor injuries.

 
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