| CTRI Number |
CTRI/2024/11/076605 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
effect of physiotherapy treatment and exercises in paralyzed patients |
|
Scientific Title of Study
|
effects of low-level laser therapy therapeutic ultrasound and electrical stimulation in altering structural and functional outcomes in spinal cord injury population |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kishoremoy das |
| Designation |
assistant professor |
| Affiliation |
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
| Address |
room no A 5th floor Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
room no A 5th floor Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
6380712597 |
| Fax |
|
| Email |
keatondev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prathap suganthirababu |
| Designation |
professor |
| Affiliation |
saveetha college of physiotherapy saveetha institute of medical and technical sciences |
| Address |
room no e4 4th floor principal office Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
room no e4 4th floor principal office Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9840340195 |
| Fax |
|
| Email |
prathap.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
kishoremoy das |
| Designation |
assistant professor |
| Affiliation |
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
| Address |
room no E4 4th floor Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
room no E4 4th floor Health science block saveetha college of physiotherapy saveetha institute of medical and technical sciences saveetha nagar thandalam chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
6380712597 |
| Fax |
|
| Email |
keatondev@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha college of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences,Saveetha Nagar,Thandalam,Chennai-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 |
| kishoremoy das |
Saveetha college of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
room no 322 3rd floor physiotherapy opd and inpatient services department
Kancheepuram
TAMIL NADU |
6380712597
keatondev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH-INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S142||Injury of nerve root of cervical spine, (2) ICD-10 Condition: S242||Injury of nerve root of thoracic spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
electrical stimulation |
electrical stimulation 5 settings per week for 12 weeks with a duration of 10 minutes and dosage cycle 5/5 with a maximum visual contraction and patient tolerance level along with conventional physiotherapy routine
which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar
|
| Intervention |
low level laser therapy
|
low level laser therapy 5 settings per week for 12 weeks with a duration of 10 minutes for each session and dosage 2-4J/cm2 along with conventional physiotherapy routine
which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar
|
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
therapeutic ultrasound |
therapeutic ultrasound 5 settings per week for 12 weeks
with a duration of 10 minutes and dosage 1Mhz with intensity 0.8 W/cm2 along with conventional physiotherapy routine
which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Spinal Cord Injury
Participants must have a documented traumatic or non-traumatic spinal cord injury resulting in neurological deficits by neuro surgeons
The level of injury should be between C1 and L5 as assessed by the International Standards for Neurological Classification of Spinal Cord Injury ISNCSCI
Time Since Injury
Participants should be within a specific time frame since the initial SCI between 3 and 12 months to ensure a similar stage of recovery
Age Range
Include participants within a defined age range 18 to 50 years to ensure a homogeneous sample
Consent and Cooperation
Obtain informed consent from potential participants or their legal guardians if necessary
Ensure participants are willing and able to cooperate throughout the study attending all required assessments and rehabilitation sessions
Medical Stability
Participants should be medically stable and free from acute medical conditions that could interfere with rehabilitation or imaging assessments
Ability to Undergo Rehabilitation
Participants should have sufficient physical and cognitive capabilities to engage in rehabilitation interventions such as LLLT LIPUSTNMES TILT TABLE etc
|
|
| ExclusionCriteria |
| Details |
Severe Medical Comorbidities
Exclude participants with severe medical conditions uncontrolled cardiovascular disease severe infections head injury with low GCS level that may interfere with the rehabilitation process or pose additional risks
Previous Spinal Surgery or Interventions
Exclude individuals who have undergone previous spinal surgery or interventions as these may confound the study results
Pregnancy
Pregnant individuals will be excluded due to potential risks associated with radiation exposure during DTI scans
Severe Neurological Conditions
Exclude participants with pre-existing severe neurological conditions multiple sclerosis Parkinsons disease that could affect the interpretation of rehabilitation outcomes
Non-Compliance
Participants who are unlikely to comply with the studys requirements or follow the rehabilitation program may be excluded
Metallic Implants or Devices
Individuals with metallic implants or devices that are not MRI-compatible may be excluded from the DTI scanning portion of the study
Non- Traumatic Spinal cord injuries
Vascular events like Spinal cord infarction or hemorrhage
Tumors like Primary or metastatic tumors compressing the spinal cord
Infections like Spinal abscess or inflammation due to infections like tuberculosis
Autoimmune conditions like transverse myelitis or multiple sclerosis affecting the spinal cord
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
DTI diffuse tensor imaging
American spinal injury association impairment scale
The spinal cord independence measurement scale SCIM
|
DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day)
American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day)
The spinal cord independence measurement scale SCIM
-Day-0(Before Intervention) and End of 12th week(After the last day)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/11/2024 |
| 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="1"
Months="6"
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
|
The current study aims to investigate the effect of Low-Level Laser Therapy, therapeutic Ultrasound and Electrical Stimulation along with conventional physiotherapy and to determine whether these interventions lead to any alteration in spinal cord fibers that subsequently influence the functional outcomes of patients with spinal cord injuries. Totally 45 participants will be included in this study after satisfying the inclusion and exclusion criteria and after obtaining their informed consent. The study is divided into three interventional group: First interventional group will recieve low level laser therapy 5 settings per week for 12 weeks with a duration of 10 minutes for each session and dosage 2-4J/cm2 along with conventional physiotherapy intervention includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar. Second group will recieve therapeutic ultrasound 5 settings per week for 12 weekswith a duration of 10 minutes and dosage 1Mhz with intensity 0.8 W/cm2 along with conventional physiotherapy intervention which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar. Third group will recieve electrical stimulation 5 settings per week for 12 weeks with a duration of 10 minutes and dosage cycle 5/5 with a maximum visual contraction and patient tolerance level along with conventional physiotherapy routine which includes Cardio Respiratory Exercises In-bed Mobilization MAT Activity Tilt Table Standing Task Specific Training Sitting within bed Trunk Stability Exercises Core Strengthening Exercises Upper Limb Strengthening Exercises Prolonged Standing with walker support using proper prosthesis Balance Training Static and Dynamic Sitting to Standing Gait Training in parallel bar. The outcome measure are: DTI diffuse tensor imaging, American spinal injury association impairement scale,The spinal cord independence measurement scale SCIM. The timeline for outcome measures are: DTI diffuse tensor imaging-Day-0(Before Intervention) and End of 12th week(After the last day) American spinal injury association impairment scale-Day-0(Before Intervention) and End of 12th week(After the last day) The spinal cord independence measurement scale SCIM-Day-0(Before Intervention) and End of 12th week(After the last day) The procured datas will be statistically analysed and disseminatted as Phd Thesis and will be updated in this CTRI portal for the benefit of common public and scientific society.
|