| CTRI Number |
CTRI/2026/02/104581 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| 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
|
Influence of Autonomic Nervous System activation on walking pattern after Spinal Cord Injury |
|
Scientific Title of Study
|
Role of Autonomic Nervous System activation in the formation of Central Pattern Generator of Locomotion in individuals with Spinal Cord Injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Physiotherapy Department Punjabi University Patiala |
| Address |
Physiotherapy Department Punjabi University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Physiotherapy Department Punjabi University Patiala |
| Address |
Physiotherapy Department Punjabi University
Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanshika Gautam |
| Designation |
Post Graduate Student |
| Affiliation |
Physiotherapy Department Punjabi University Patiala Punjab 147002 India |
| Address |
Physiotherapy Department Punjabi University
Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
7528058995 |
| Fax |
|
| Email |
vanshikagautam1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vanshika Gautam |
| Address |
Physiotherapy Department Punjabi University Patiala
Punjab
147002
India |
| 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 Narkeesh Arumugam |
Bhai Ghaniya Health Centre and Neuroots Neurorehabilitation centre |
Physiotherapy Unit Neurological OPD II Punjabi University Patiala Punjab
Neuroots
Neurorehabilitation centre Patiala Punjab
Patiala
PUNJAB |
9417802662
narkeesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Punjabi University Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Activity Based Therapy and Conventional Rehabilitation |
Surface Spinal Stimulation, Photobiomodulation therapy Body Weight Support Treadmill Training and Conventional Rehabilitation for 5 sessions per week for 3 weeks |
| Intervention |
Autonomic Nervous System Activation Protocol
Activity Based Therapy and Conventional Rehabilitation
|
Surface Spinal Stimulation Photobiomodulation therapy Body Weight Support Treadmill Training.
Repetitive Trans spinal Magnetic Stimulation
Percutaneous Tibial Nerve Stimulation
Intermittent Pneumatic Compression Therapy
Intermittent Hold and Cold Application
Aerobic Training for Cardiopulmonary System and
Conventional Rehabilitation for 5 sessions per week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASIA Impairment Scale B to D
Individuals with traumatic incomplete SCI for a minimum of 6 months
Both males and females
Individuals with Autonomic Dysfunction affecting multiple systems including cardiovascular gastrointestinal genitourinary thermoregulatory and psychological domains
Individuals who will be willing to participate and able to give informed consent |
|
| ExclusionCriteria |
| Details |
Individuals with other neurological and orthopedic conditions such as peripheral nerve injury brachial plexus injury cauda equina syndrome head injury or osteoporosis
Individuals with cognitive impairment MMSE score of less than 24
Individuals who have experienced major surgery or trauma during the past 6 months
Individuals with metallic implants in their body
Individuals who are susceptible to autonomic dysreflexia
Musculoskeletal injury affecting the lower extremities that may impact locomotion
Uncooperative individuals
Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
American Spinal Injury Association Motor and Sensory Scores
Walking Index for Spinal Cord Injury II |
Day 0
Day 10
Day 20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Spinal Cord Independence Measure III
General Autonomic Function and Sacral Autonomic Function International Standards for the documentation of remaining Autonomic Function after Spinal Cord Injury |
At the Baseline
10th day and 20th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/03/2026 |
| 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="6"
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
|
Spinal Cord Injury SCI is a debilitating neurological condition causing significant motor sensory and autonomic dysfunctions impacting 6.2 million people globally. SCI disrupts motor signals affecting voluntary movement and locomotion. Central Pattern Generators CPG regulate complex behaviours including as locomotion mastication respiration defecation micturition and movement. Physiotherapy intervention including resistance training electrical stimulation and activity based training aim to improve muscle strength and locomotion. However, autonomic nervous system ANS dysfunction is often neglected affecting cardiovascular thermoregulatory and other essential systems. This oversight contributes to delayed and incomplete recovery highlighting a critical gap in management strategies. The study aims to investigate ANS dysfunction and its modulation to improve functional outcomes and quality of life for individuals with SCI |