FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091719 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [occupational therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving Daily Life Independence in People with Spinal Cord Injury by Watching Others Perform tasks. 
Scientific Title of Study   Rehabilitation after Spinal Cord Injury: Enhancing Functional Independence through Action Observation Therapy – A Single-Blinded, Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreyalakshmi C V 
Designation  Student 
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy Department of PMR Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  06235224306  
Fax    
Email  sreyalakshmicv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sreyalakshmi C V 
Designation  Student 
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy Department of PMR Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  06235224306  
Fax    
Email  sreyalakshmicv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Selvaraj samuelkamaleshkumar 
Designation  Professor  
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy Department of PMR Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9894465407  
Fax    
Email  stopatsams@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
internal fluid research grant Christian Medical College Vellore, Tamil Nadu , 632004, India 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College Vellore 632008 
Type of Sponsor  Private medical college 
 
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 
MsSreyalakshmi C V  Christian Medical College   Department of PMR Rehabilitation Institute Christian Medical College Vellore TAMIL NADU
Vellore
TAMIL NADU 		 6235224306

sreyalakshmicv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College, Vellore  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  Action Observation Therapy  Participants in the intervention group will receive 30 minutes of AOT per day in addition to the conventional occupational therapy received by the control group. The videos will be shown to groups of 3-4 participants at a time. Participants will watch the next sequential video based on their individual progress. During the 30 minute they will be shown the videos of activities that they are going to perform for the week. This will be scheduled immediately before the conventional therapy session to prime motor learning. A total of 39 AOT videos will be used in the study. The AOT videos will be scripted and recorded based on the structured rehabilitation protocol currently in practice at the Rehabilitation Institute, CMC Vellore. They will feature real patients demonstrating SCI-relevant tasks such as: •Trunk control and sitting balance (long sitting, high sitting, dynamic balance) •Wheelchair mobility (basic propulsion, obstacle negotiation, maneuvering on slopes and uneven surfaces) •Transfers (wheelchair to bed, toilet, car, floor, and vice versa) •Pressure relief techniques (wheelchair push-ups) •Community mobility tasks (curb climbing, stair ascent/descent, navigating doors and thresholds) The videos will be functionally progressive, structured to match the rehabilitation milestones typically achieved over an 8-week inpatient program. Each video will be approximately 2 to 3 minutes long. For each 30-minute AOT session, participants will watch a curated set of 5–6 videos. Videos will be shown on a monitor in a quiet therapy room. It will be shown before engaging in practical activities. This timing allows participants to observe the movement strategies first and then attempt to replicate them during their occupational therapy sessions. The AOT sessions will be conducted in a supervised setting within the Rehabilitation Institute and it will be delivered by trained occupational therapists from the Department of PMR, CMC Vellore. These therapists will be oriented to the AOT protocol before the intervention phase begins. They will be present during each 30-minute session to ensure full attendance and active engagement. They will not be involved in outcome assessments at any stage of the study. They will ensure the correct video is shown based on the participant’s functional status and rehabilitation week, and they will monitor engagement, attendance, and adherence. Therapists will track progress and ensure participants move to the next video set only after completing the previous one, promoting consistency. 
Comparator Agent  Interdisciplinary Rehabilitation Program  Participants in the control group will undergo a patient-specific multidisciplinary rehabilitation program involving conventional occupational therapy, physical therapy for 5 days, 6 hours/day, over 8 weeks During the Occupational therapy sessions, the patients with SCI will undergo the following, Functional Training (Therapy Plinth): Rolling Coming up to sit High-sitting Long-leg sitting Push-ups Balance training Ball throwing Stooping in forward and sideways Standard Wheelchair Training: Push-ups Rolls 10 m forward Rolls 10 m backward Turns 90° while moving forward Turns 90° while moving backward Picks object from floor Reaches 1.5m high object Rolls forward 10 m in 30 s Turns 180 degree in place left and right Ascends 5-degree incline Descends 5-degree incline Rolls 200m Ascends 10-degree incline Descends 10-degree incline Avoids moving obstacles left and right Maneuvers sideways left and right Pops castors up Gets through hinged door both directions Rolls 2 m on soft surface Rolls 2m across 5-degree side slope left and right Gets over 2cm threshold Games in sports wheelchair 30 s stationary wheelie Ascends 5cm level change Descends 5cm level change Gets over 15cm pot hole Folds and unfolds wheelchair Turns 180-degree in place in wheelie position left and right Ascends 15cm 1curb Descends 15cm curb Ascends stairs Descends stairs Community ambulation Transfers: Transfers from wheelchair to plinth and back Chair and toilet stool transfer Car and auto transfer Gets from ground into wheelchair Gets in and out of tricycle ADL training: Feeding Grooming and hygiene Dressing Bathing Toileting During the 30-minute period when the intervention group undergoes Action Observation Therapy (AOT), the control group will be provided with reading materials related to spinal cord injury. This will ensure that both groups remain engaged in SCI-related learning during this time. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age: 18 to 60 years
Onset of injury: Within 6 months
Level of injury: T2 to L1
Patients who are willing to give consent
 
 
ExclusionCriteria 
Details  Patients with any pressure sores
Patients with severe spasticity
Patients with heterotrophic ossification
Patients with any other comorbidities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in wheelchair mobility and skill performance.
2.Improvement in sitting balance and functional reach.
 		 1.at baseline
2.after 4 weeks
3.after 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improved functional independence in daily living activities.
2.Reduction in neuropathic pain symptoms. 		 1.at baseline
2.after 4 weeks
3.after 8 weeks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   11/08/2025 
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="2"
Months="0"
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  
Spinal Cord Injury (SCI) is a neurological condition that leads to significant functional impairments, affecting independence and quality of life. Traditional rehabilitation focuses on physical exercises and compensatory strategies, but these are often limited by severe paralysis, muscle atrophy, and learned nonuse of affected part. To enhance recovery, innovative approaches that harness neuroplasticity, such as motor priming, are needed.
Motor priming is a technique where prior exposure to a stimulus enhances subsequent motor behaviors by preparing neural pathways for movement, optimizing rehabilitation outcomes. Techniques like movement-based priming, motor imagery, and Action Observation Therapy (AOT) facilitate motor recovery by inducing neuroplastic changes.
SCI also disrupts embodiment, causing individuals to perceive their paralyzed limbs as disconnected. Emerging interventions, such as virtual reality (VR) and multimodal feedback, help restore limb ownership, alleviate neuropathic pain, and improve motor function.
AOT therapy, a cost-effective intervention, involves observing goal-directed actions to activate the mirror neuron system, which is crucial for motor learning. It has shown success in stroke and Parkinson’s disease rehabilitation, suggesting potential benefits for SCI patients in relearning task-specific skills such as wheelchair propulsion, transfers, and self-care. Despite promising findings, AOT’s effectiveness in SCI rehabilitation remains underexplored.
This study aims to evaluate AOT’s role in improving functional independence, preventing learned nonuse, and improving task-specific skills in SCI rehabilitation. By integrating AOT, this research seeks to provide scalable, evidence-based solutions to improve the functional independence for individuals with SCI. The patients admitted in rehabilitation institute, and who fulfill the inclusion criteria will be randomly divided into two groups as experimental and control group. The patients in the control group will receive conventional occupational therapy intervention. The patients in the experimental group will receive conventional occupational therapy intervention and AOT where they will be showed videos of activities like wheel chair propulsions and transfers prior to actual performance for 30 minutes per session for 8 weeks.
 
Close