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CTRI Number  CTRI/2021/04/032598 [Registered on: 07/04/2021] Trial Registered Prospectively
Last Modified On: 25/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A STUDY TO COMPARE THE EFFECTIVENESS OF TRUNK TRAINING EXERCISE IN CONJUNCTION WITH MUCSLE STIMULATOR VERSUS TRUNK TRAINING EXERCISE ALONE ON TRUNK BALANCE IN INDIVIDUAL WITH SPINAL CORD INJURY 
Scientific Title of Study
Modification(s)  		 EFFECTIVENESS OF GOAL ORIENTED TASK SPECIFIC TRAINING IN CONJUNCTION WITH NMES ON TRUNK BALANCE 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  ARCHANA RAWAT 
Designation  STUDENT 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Rehabilitation Department Indian Spinal Injuries Center, Institute of Rehabilitation Sciences.

South
DELHI
110070
India 
Phone  7838024841  
Fax    
Email  rawat.19archana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shefali walia 
Designation  Associate Professor ( Physiotherapist) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Rehabilitation Department ,Indian Spinal Injuries Center Institute of Rehabilitation Sciences

South
DELHI
110070
India 
Phone  9891770151  
Fax    
Email  shef0604@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shefali walia 
Designation  Associate Professor ( Physiotherapist) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Rehabilitation Department Indian Spinal Injuries Center, Institute of Rehabilitation Sciences.

West
DELHI
110070
India 
Phone  9891770151  
Fax    
Email  shef0604@gmail.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable 
Type of Sponsor  Other [NIL] 
 
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 
Archana Rawat  ISIC institute of Rehabilitation Sciences  Rehabilitation Department ,Neurology spine division , Ground floor
South
DELHI 		 7838024841

Rawat.19archana@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1)NMES 2)GOAL ORIENTED TASK SPECIFIC TRANING  NMES( 4 ELECTRODES,2 over thoracic errector spinae, and two over lumbar errector spinae ) GOAL ORIENTED TASK SPECIFIC TRAINING (includes 6 sets of exercise ,3 sets 10repetion each 5 days a week for 3 weeks. 
Comparator Agent  1)NMES (SHAM) 2)GOAL ORIENTED TASK SPECIFIC TRAINING  NMES( 4 ELECTRODES,2 over thoracic errector spinae, and two over lumbar errector spinae )Sham-intervention group will be manage in an identical manner to the NMES group, but amplitude will be set at 0 mA so no electrical stimulation will be given GOAL ORIENTED TASK SPECIFIC TRAINING (includes 6 sets of exercise ,3 sets 10repetion each 5 days a week for 3 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient with SCI( traumatic/ non traumatic)
2)Participants with Age 18–60 years
3)Atleast 3 months prior to the study
4)ASIA grade B ,C and D SCI who are receiving physical and occupational therapy.
5) C5 or below neurological level.
6)Able to sit unsupported for at least 10 seconds.
7)90 degree or more shoulder flexion. 
 
ExclusionCriteria 
Details  1)Progressive non traumatic SCI.
2)Participants with cognitive impairment (inability to understand Instructions, Mini Mental State Examination score ⩽ 24.
3)Orthopedic problems influencing unsupported sitting or Deformity of Upper extremity.
4)Pressure ulcers on the buttocks ,grade 3 & 4 or had pressure areas necessitating bed rest.
5)Cardiopulmonary insufficiency, cardiac pacemaker, Oncological disease, epilepsy, open wounds, or metal implants in the area where electrical stimulator is plan to be perform.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Modified Functional Reach Test
2) Function In Sitting Test(FIST)
 		 (0 day - 3 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
1)SCIM III Version  (0 days - 3 weeks) 
 
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)   12/04/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
AIM: Aim of the study is to evaluate the effect of goal oriented task specific training in conjunction with NMES in improving Trunk balance in individual with SCI. In people with SCI the changes in sensation, loss of muscle strength , and the presence of spasticity amongst other pathological changes can severely impair postural control and sitting balance leading to difficulties with most basic ADL’s. Injuries of the spinal cord in the cervical and thoracic vertebral region lead to motor and/or sensory impairment of the trunk. Individuals with neurological SCI levels T10 to C1 have severely affected trunk control which has an impact on their sitting balance, and this could result in backward pelvis tilting and compromised seated posture. As a result, people with SCI use innervated, non-postural muscles (e.g., latisumus dorsi and pectoralis major) to compensate for the impairment, but their sitting balance still remains compromised. Moreover, during reaching tasks most individuals with SCI use one arm to maintain support by holding the wheelchair or by pivoting it on the lap for support . Other mechanical solutions for improving sitting balance include chest straps , seat cushions , foot rests and wheelchair adjustments but these solutions are limiting since they improve balance at the cost of reduced trunk mobility. Most SCI individual spend time in wheelchair therefore activities and balance training in sitting is important to improve the quality of life as well as rehabilitation program.
There are various methods for improving balance ability of SCI population. Recent rehabilitation program include balance training for SCI population using goal oriented task specific training. Goal oriented task specific training have been reported to be an effective method in that they increases the training amount and function and also arouses patient interest and attention by repeating task.
Another intervention NMES is a therapeutic modality in which muscle contraction is electrically stimulated in the area where surface electrodes are attached. It ameliorates Muscle atrophy and weakness secondary to immobilization and improves muscle strength via somatosensory stimulation that increases cortical excitability. Researchers have concluded that there is some suggestion that NMES increases voluntary strength in partially paralyzed muscle following SCI.
This study is designed to test the idea of comparing the effectiveness of 2 treatment protocol 1) Goal oriented task specific training 2) Goal oriented task specific training + NMES for subject with incomplete SCI.
The outcome measure will focus on trunk strength , balance and functional independence in sitting using MFRT, FIST and SCIM III version.
The total duration of intervention will be 3 weeks with a frequency of 5 times a week with each session of 30 min.
Paired and unpaired t-test will be used to evaluate the result.
Restoration of sitting balance is one of the goal of rehabilitation, however the effect of sitting balance training with NMES in conjunction with Goal oriented task specific training has not been specifically investigated. So the aim is to investigate the additive effects of combining two intervention on trunk balance in SCI patients.
 
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