| 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
|
|
|
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
|
|
|
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
|
|
|
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. |