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CTRI Number  CTRI/2026/02/103545 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
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 clinical study to improve arm and hand movement in people with spinal cord injury using mild to moderate electrical signals together with daily activity practice. 
Scientific Title of Study   Effectiveness of integrating Functional electrical stimulation with Task oriented training in improving the upper limb function in individuals with spinal cord injury 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHELLY SHARMA 
Designation  MPT-Neurology student 
Affiliation  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences 
Address  Physiotherapy Department, 2nd floor,Indian Spinal Injuries Centre ,New Delhi 110070 India

South
DELHI
110070
India 
Phone  8368301980  
Fax    
Email  shellysharma2304@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  STUTI SEHGAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences 
Address  Physiotherapy Department, 2nd floor,Indian Spinal Injuries Centre ,New Delhi 110070 India

South
DELHI
110070
India 
Phone  9891847488  
Fax    
Email  sehgalstutiss@gmail.com  
 
Details of Contact Person
Public Query  
Name  STUTI SEHGAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences 
Address  Physiotherapy Department, 2nd floor,Indian Spinal Injuries Centre ,New Delhi 110070 India

South
DELHI
110070
India 
Phone  9891847488  
Fax    
Email  sehgalstutiss@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences,Vasant Kunj,New Delhi 110070  
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre 
Address  Indian Spinal Injuries Centre,Physiotherapy Department 2nd floor,IAA Colony, Sector C, Vasant Kunj, New Delhi,Delhi 110070,INDIA  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHELLY SHARMA  Indian Spinal Injuries Centre  Physiotherapy Department, 2nd floor,Indian Spinal Injuries Centre, IAA Colony, Vasant Kunj, New Delhi 110070
South
DELHI 		 8368301980

shellysharma2304@gmail.com 
 
Details of Ethics Committee  
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: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional electrical stimulation (FES)+ task oriented training(TOT)  Fold towel turn once Holding a cup and drink from it Exercises with putty (squeezing, pinching ,making balls) Simulated eating, Stacking glass on top of each other, for 30-45 mins per session.Total duration 5 times a week for 4 weeks.  
Comparator Agent  Task oriented training + Sham FES   Fold towel turn once Holding a cup and drink from it Exercises with putty (squeezing, pinching ,making balls) Simulated eating, for 30-45 mins per session.Total duration 5 times a week for 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60 years
Level of injury C5 to C7
Duration more than 3 months
Individuals should have some level of thumb and finger movements
Able to tolerate being in a seated position for a least 1 hour required to deliver upper limb therapy
 
 
ExclusionCriteria 
Details  Individuals who had contraindications for FES, such as a cardiac pacemaker, skin lesions, or a rash at a potential electrode site
Uncontrolled hypertension or autonomic dysreflexia requiring medication
History of seizure disorder not effectively managed by seizure medications.
Currently dependent on a ventilator
Previous history of any other neuromuscular disorder or conditions that may affect motor response
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Box and Block test  4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Capabilities of upper extremity questionnaire(English and Hindi)
 		 4 WEEKS 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   20/02/2026 
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="7"
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  
TITLE EFFECTIVENESS OF INTEGRATING FUNCTIONAL ELECTRICAL
STIMULATION WITH TASK ORIENTED TRAINING IN IMPROVING THE
UPPER LIMB FUNCTION IN INDIVIDUALS WITH SPINAL CORD INJURY
BACKGROUND
Spinal cord injury (SCI) frequently results in profound motor deficits, severely compromising
the well-being and daily functioning of individuals. The primary injury involves damage to
neural parenchyma, disruption of axonal networks, and disturbance of glial membranes,
halting transmission of signals from upper motor neurons to areas below the injury.
Functional Electrical Stimulation (FES) provides electrical pulses to stimulate motor neurons
and facilitate muscle contractions, while Task Oriented Training (TOT) emphasizes repetitive
practice of functional tasks. Although both interventions, FES and TOT have proven benefits
individually, their integrated application may enhance motor recovery by combining neural
activation with functional task practice. This study aims to evaluate the effectiveness of
integrating FES with TOT in improving fine and gross hand functions in individuals with
SCI.

OBJECTIVE
To determine the effect of integrating FES with task oriented training for hand functions in
individuals with spinal cord injury.
HYPOTHESIS:
NULL HYPOTHESIS-
H N There is no significant difference between the effects of integrating FES with task
oriented training on hand functions in individuals with spinal cord injury
ALTERNATE HYPOTHESIS-
H A There is significant difference between the effects of integrating FES with task oriented
training on hand functions in individuals with spinal cord injury

MATERIALS AND METHODS
STUDY DESIGN Experimental study design
SAMPLE SIZE 24 (12 in each group)
(Outcome measure used is Box and block test)
Song GB. The effects of task-oriented versus repetitive bilateral arm training on upper limb function and activities of daily
living in stroke patients.
ENROLMENT PERIOD 6-7 months after RRC and IEC clearance

INCLUSION CRITERIA
1. Age 18 to 60 years
2. Level of injury C5 to C7
3.Duration more than 3 months
4. Individuals should have some level of
thumb and finger movements
5. Able to tolerate being in a seated
position for a least 1 hour required to
deliver upper limb therapy

EXCLUSION CRITERIA
1. Individuals who had contraindications for
FES, such as a cardiac pacemaker, skin
lesions, or a rash at a potential electrode
site
2. Uncontrolled hypertension or autonomic
dysreflexia requiring medication
3. History of seizure disorder not effectively
managed by seizure medications.
4. Currently dependent on a ventilator
5. Previous history of any other
neuromuscular disorder or conditions that
may affect motor response

TOTAL STUDY DURATION 4 weeks intervention duration.
STUDY PROCEDURES Patients will be screened based on inclusion and exclusion criteria.
They will be enrolled into 2 groups with the help of random allocation software.
Experimental Group A (FES+TOT) will receive Functional electrical stimulation and Task
oriented training, 5 times a week for 4 weeks. Experimental Group 2 (TOT+shams FES) will
receive task oriented training for the same duration.
ASSESSMENT TOOLS Pre- and post-intervention tests will be carried out using

Box and Block test (BBT)–to measure gross manual dexterity of
the upper limb.
Capabilities of Upper Extremity Questionnaire (CUE-Q) to assess
the functional use of upper limbs and covers gross and fine motor
skills.

STATISTICAL ANALYSIS PLAN (SAP):
Descriptive statistics will calculate the mean and standard deviation for quantitative
variables (e.g. age, BBT score) and frequencies for categorical variables (e.g.,
gender).
The Shapiro-Wilk test will assess normality.
If the data is normally distributed, an independent t-test will evaluate differences
between the groups.
Paired t-test will be used to evaluate average difference within the group for normal
data.
 For skewed data, the Wilcoxon signed-rank test will assess within-group changes, and
the Mann-Whitney U test will compare between-group differences.
Data will be analysed using SPSS 21 with Excel for data management.
Statistical significance will be set at a 5% alpha level.
 
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