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CTRI Number  CTRI/2024/11/076922 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
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   watching and executing task vs repetition of task for upper limb function in individual with cervical spinal cord injury 
Scientific Title of Study   Comparative Effectiveness of Action Observation Therapy and Task Oriented Therapy on Upper Limb Functions in Individuals with cervical 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  Shreesha 
Designation  Postgraduate student(master of physiotherapy) 
Affiliation  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation, Department of Neurorehabilitation, 2nd floor, Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9899212520  
Fax    
Email  choudharyshreesha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Garima Wadhwa 
Designation  Assistant professor  
Affiliation  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation, Department of Neurorehabilitation, 2nd floor, Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shreesha 
Designation  postgraduate student (masters of physiotherapy) 
Affiliation  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences 
Address  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation, Department of Neurorehabilitation, 2nd floor, Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9899212520  
Fax    
Email  choudharyshreesha@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, physical medicine and rehabilitation, department of neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi- 110070. 
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  Sector C, Vasant Kunj, New Delhi - 110070 
Type of Sponsor  Research institution and hospital 
 
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 
Shreesha  Physical MedicinIndian Spinal Injuries Centre - Institute of Rehabilitation Sciences  Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Physical Medicine and Rehabilitation, Department of Neurorehabilitation, 2nd floor, Sector C, Vasant Kunj, New Delhi
South West
DELHI 		 09899212520

choudharyshreesha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Indian Spinal Injuries Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S142||Injury of nerve root of cervical spine, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (3) ICD-10 Condition: G825||Quadriplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Action Observation Therapy  patients are shown videos of tasks they have to perform. Patients have to observe the video, imitate it and then execute the same task shown in the video. 
Comparator Agent  Task Oriented Therapy  Patients will be asked to do multiple repetition of functional tasks given to them with the help of verbal feedback. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Neurological level:c6 to c8
2.Duration of injury ≥ 3 months.
3.Individuals with mini mental status examination(MMSE) score ≥ 24.
4.Patients should have some level of finger and thumb movements.
 
 
ExclusionCriteria 
Details  1.Patients with seizure disorders, epilepsy and other neurological conditions that will interfere in study as per medical records.
2.Patients who could not cooperate due to dementia and psychosis that will hinder the study confirmed by their medical reports.
3.Patients with recent or past history of injury/ deformity/ fracture or other upper limb problems that limit participation in study.
4.Modified Ashworth spasticity scale ≥3 with severe spasticity in upper limb.
5.Uncorrected visual and hearing impairment that would interfere in study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Jebsen Taylor Hand Function Test
 		 0 weeks(baseline, pre-test) and 4 weeks(post-test) 
 
Secondary Outcome  
Outcome  TimePoints 
Box and Block Test  0 weeks(baseline, pre-test) and 4 weeks(post-test) 
CUE questionnaire  0 weeks(baseline, pre-test) and 4 weeks(post-test) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) 12/05/2025 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Impaired hand functions severely limits the ability of people with cervical spinal cord injury (SCI) to perform activities of daily living (ADLs). These injuries can impact the nerves that control the muscles in shoulder, arm and hand leading to varying degree of weakness, loss of movement and sensations. As human being need their hands to perform their day to day activities, patients with cervical SCI lacks in it.

Action observation therapy is a novel rehabilitation approach exploiting the mirror mechanism and its potential role in motor learning for motor recovery. In this approach the observation and imitation skills of the patient is tested. Task-oriented therapy is a technique in which multiple repetitions of a specific task is practiced until patient can perform it by his own without making marked errors. these two are very promising approaches to develop rehab strategies for upper limb movements patients with cervical spinal cord injury, but they have never been compared to one another. Hence this research aims to find their comaparative effectiveness on upper limb functions in cervical spinal cord injury patients.

Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into two groups with the help of random allocation software. One group (experimental group) will receive Action Observation Therapy with conventional physiotherapy 5 times a week for 4 weeks. Whereas the second group (control group) will receive Task Oriented Therapy with conventional physiotherapy for the same duration.

The outcome measurement will be done with Jebsen Taylor hand function test, box and block test and CUE (capabilities of upper limb) questionnaire. Variations in pre and post outcome measurement will help us to find the comparative effectiveness of Action Observation Therapy and Task Oriented Therapy on upper limb function in individuals with cervical spinal cord injury. 
 
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