| CTRI Number |
CTRI/2023/02/049536 [Registered on: 08/02/2023] Trial Registered Prospectively |
| Last Modified On: |
04/01/2023 |
| 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
|
DEVELOPMENT, VERIFICATION AND EFFECTIVENESS OF CORTICOSPINAL ACTIVATION PROTOCOL ON CENTRAL PATTERN GENERATOR IN INDIVIDUALS WITH SPINAL CORD INJURY |
|
Scientific Title of Study
|
FORMULATION, VALIDATION AND EFFECTIVENESS OF CORTICOSPINAL ACTIVATION PROTOCOL ON CENTRAL PATTERN GENERATOR 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 |
Sharanjeet Kaur |
| Designation |
Junior Research Fellow |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy,
Punjabi University,
Patiala
Department of Physiotherapy,
Punjabi University,
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
8556896753 |
| Fax |
|
| Email |
drkaursharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy,
Punjabi University,
Patiala
Department of Physiotherapy,
Punjabi University,
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy,
Punjabi University,
Patiala
Department of Physiotherapy,
Punjabi University,
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Punjabi University, Patiala
147001 |
|
|
Primary Sponsor
|
| Name |
Punjabi University |
| Address |
Department of Physiotherapy
Punjabi University
Patiala |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Narkeesh Arumugam |
Punjabi University Patiala |
Department of Physiotherapy
Punjabi University
Patiala, 147001
Patiala
PUNJAB |
9417802662
narkeesh@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy
|
Conventional Physiotherapy
for 4 weeks |
| Intervention |
Corticospinal Activation Protocol |
Corticospinal Activation Protocol for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals willing to enroll in the study
2.Individuals falling within the age group of 20-65 years
3.Both males and females will be included in the study.
4.Individuals with traumatic or non-traumatic incomplete SCI with ASIA grade C and D.
5.Individuals with intact cognitive function i.e. MMSE greater than or equals to 26
|
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| ExclusionCriteria |
| Details |
1. Individuals with a history of cognitive deficit, psychosomatic illness.
2. Individuals with a history of epilepsy, head injury, or loss of consciousness.
3. Individuals with visual disability.
4. Individuals who will not cooperate.
5. Individuals with congenital spinal deformities and diseases like neural tube defects.
6. Individuals with Pregnancy, Metastasis
7. Individuals with metabolic and any kind respiratory or communicable disease.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Motor Evoked Potentials, MEPs
Somato-Sensory Evoked Potentials, SEPs |
5 sessions per week for 4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Asia Impairment Scale (AIS) Scores
Walking Index for Spinal Cord Injury (WISCI)
Spinal Cord Independence Measure-III
|
Day 0, Day 15, Day 30 |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
31/12/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Protocol Publication, Case Study Publication,Case Series Publication, Systematic Review Publication, Complete Study Publication |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Background: Spinal Cord Injury refers to a destructive,neurological and pathological state in which there occurs damage to the neural elements of the spinal cord. This damage can be due to traumatic and non-traumatic lesions which lead to dysfunctions in the functioning and participation of human being in the society (Bedi et al., 2018). Locomotion is a basic motor act which is essential for the survival of humans (Ray et al.,2022). The basic muscle synergies which are responsible for body propulsion are generated by the neurons in spinal cord collectively known as Central Pattern Generator for Locomotion. SCIs are heterogeneous in casualty, severity and location of injury but Locomotion is the ultimate goal for the post-SCI survivors (Hang et al., 2010). In order for locomotion to occur, a complex CPG center of Locomotion activation is required. Exercise based approach i.e. Corticospinal Activation Protocol (CAP) is the cornerstone in the treatment and management of individuals with SCI. Study Design: A Randomised Controlled Trial Objective: To determine the effectiveness of CAP on the activation of CPG in individuals with spinal cord injury
Methodology:The individuals with SCI/D will be screened and recruited for the study as per the selection criteria. Written consent will be obtained before the commencement of the study from the participants (Annexure III). Step-I: A baseline evaluation on Day 0 will be done by using primary and secondary outcome measures of the study i.e MEPs, SEPs, WISCI, SCIM-III. Step II: The participants will be allocated into two groups. Group A (Experimental Group) and Group B (Control Group)) based on the randomization. Step III: The protocol will be administered on the next day i.e at Day 1. After the selection of participants, the administration of protocol will be done which depends upon the allocated group. Experimental Group: Group A For group-A CAP which includes Corticospinal Activation Protocol to activate CPG in the Spinal cord will be administrated to the participants 5 days weekly for 45 minutes along with conventional physiotherapy. Each participant will be randomly assigned. Control Group: Group B For group B (control group),45 minutes of conventional exercise sessions will be given including strengthening exercises of the upper limb, trunk, and lower limb, body weight support treadmill training, functional electrical stimulation, balance and proprioception training Step IV: The Post-intervention recordings for the outcome measures of the study i.e. AIS Scores MEPs, SEPs, WISCI-II, SCIM-III will be recorded on Day 15 and Day 30. Step V: Data will be collected and statistical analysis will be done using SPSS 16.0 Conclusion: An articulate approach and combinative approach utilizing neuroprotective and neuroregenerative strategies to simultaneously targeting multiple pathways will be beneficial for SCI patients. There is great demand for simple, multifaceted treatment method to maximize the effectiveness of neurorehabilitative strategy for SCI.
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