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CTRI Number  CTRI/2024/10/075888 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
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   Comparative Study of Functional Reaching Activities versus Proprioceptive Neuromuscular Facilitation Techniques in Paraplegia 
Scientific Title of Study   Comparative Study of Functional Reaching Activities versus Proprioceptive Neuromuscular Facilitation Techniques on Sitting Balance in Individuals with Paraplegia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tripti Apurva 
Designation  MPT student 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
Address  Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur RAJASTHAN 302022 INDIA

Jaipur
RAJASTHAN
302022
India 
Phone  9636197587  
Fax    
Email  tripti1979@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh Kumar Khandelwal 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
Address  Neurology Physiotherapy lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9928428453  
Fax    
Email  drkneurophysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rakesh Kumar Khandelwal 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology , 
Address  Neurology Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9928428453  
Fax    
Email  drkneurophysio@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Industrial Area, Sitapura, Jaipur, Rajasthan,(India) 302022  
 
Primary Sponsor  
Name  Tripti Apurva 
Address  C-61, Dayanand Colony, Ramnagar, Ajmer, Rajasthan 305001 
Type of Sponsor  Other [Self] 
 
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 
Dr Rakesh Kumar Khandelwal  Mahatma Gandhi Hospital, Jaipur  Neurosurgery ward 8th Floor, SRCC, Mahatma Gandhi Hospital, MGUMST, Jaipur
Jaipur
RAJASTHAN 
9928428453

drkneurophysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahatma Gandhi University Of Medical Sciences and Technology, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional Reaching Activities  Functional Reaching Activities will be performed on 15 subjects. The exercises included tasks that involved moving the upper body over and outside the base of support. Each exercise had three variations: one each for people with limited, average and very good ability to sit unsupported. Participant Selection: Patients are included according to inclusion and exclusion criteria of this study Initial Assessment: Evaluate baseline sitting balance using standardised assessments(SBS) Identify specific limitations and challenges in sitting balance. Intervention Components: Functional Reaching Activities: Tailor activities to individual abilities. Incorporate reaching in multiple directions (anterior and lateral). - Utilize reaching tasks that mimic daily functional movements. Session Structure: Frequency; and Duration Warm-up: Gentle stretching and range of motion exercises for upper body. Deep breathing exercises to promote relaxation. Main Activities: Seated reaching exercises with varying arm trajectories. Integration of reaching tasks into functional activities (e.g., reaching for objects, transferring items). Progression: Gradual increase in the complexity of reaching tasks. Incorporate dynamic elements, such as reaching while seated on an unstable surface Treatment Duration 45 - 60 minutes 5 days a week  
Comparator Agent  Proprioceptive Neuromuscular Facilitation   Proprioceptive Neuromuscular Facilitation (PNF technique) will be performed on 15 subjects. Rhythmic initiation: Rhythmic motion of the limb or body through the desired range, starting with passive motion and progressing to active resisted movement. Combination of isotonic: Rhythmic motion of the limb or body through the desired range, starting with passive motion and progressing to active resisted movement. Stabilising reversal: Alternating isotonic contractions opposed by enough resistance to prevent motion. The command is a dynamic command (pushes against my hands, or don’t let me push you) and the therapist allows only a very small movement. Rhythmic stabilisation: Alternating isometric contractions against resistance, no motion intended. Treatment Duration 45 - 60 minutes 5 days a week  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Spinal cord injury (Paraplegia)
American Spinal Cord Injury grade C and D
Incomplete thoracic level(T6 to T12)
Incomplete lumbar level
Post-operative spinal surgery
Wheelchair dependent more than 50 percent patient
Subjects that will be medically and clinically stable after surgery will be taken.
Subjects willing to participate in the study.
Subjects able to provide verbal and written consent.
 
 
ExclusionCriteria 
Details  Subjects who have met one of the following criteria will be excluded from the study:
Spinal cord injury (cervical)
Quadriplegia
Quadriparesis
Tumour in spinal cord
Traumatic brain injury
Vestibular disorders
Pressure ulcers (buttocks)
Participants with recurrent stroke
Post-operative renal failure.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sitting Balance Measure scale (SBM)  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life   2nd week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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  

The eligibility of the participants will be taken on the basis of the inclusion criteria of this research study. The informed consent will be taken from 30 subjects that will be selected according to the inclusion criteria.

 

Pre-Test Procedure:- All the patients who will be involved in the study will be given consent form for their willingness to participate in the study.

The demographic data of the patient will be taken on day 1 before starting the treatment intervention.


The Sitting Balance Measure scale (SBM) score will be taken on day 1 before staring the treatment intervention.

 

Treatment Protocol:-

 

Group A : Functional Reaching Activities will be performed on 15 subjects. The exercises included tasks that involved moving the upper body over and outside the base of support.

Each exercise had three variations: one each for people with limited, average and very good ability to sit unsupported.

 

  Participant Selection: Patients are included according to inclusion and exclusion criteria of this study

 

  Initial Assessment:

Evaluate baseline sitting balance using standardised assessments(SBS)

Identify specific limitations and challenges in sitting balance.

 

 Intervention Components:

  Functional Reaching Activities:

  Tailor activities to individual abilities.

  Incorporate reaching in multiple directions (anterior and lateral). - Utilize reaching tasks that mimic daily functional movements.

 

 Session Structure: Frequency; and Duration

 

  Warm-up:

 Gentle stretching and range of motion exercises for upper body.

Deep breathing exercises to promote relaxation.

 

  Main Activities:

 Seated reaching exercises with varying arm trajectories.

Integration of reaching tasks into functional activities (e.g., reaching for objects, transferring items).

 

  Progression:

   Gradual increase in the complexity of reaching tasks.

  Incorporate dynamic elements, such as reaching while seated on an unstable surface

 

Group B: Proprioceptive Neuromuscular Facilitation (PNF technique) will be   performed on 15 subjects.

 

 Rhythmic initiation: Rhythmic motion of the limb or body through the desired range, starting with passive motion and progressing to active resisted movement.

 

 Combination of isotonic: Rhythmic motion of the limb or body through the desired range, starting with passive motion and progressing to active resisted movement.

 

  Stabilising reversal: Alternating isotonic contractions opposed by enough resistance to prevent motion. The command is a dynamic command (pushes against my hands, or don’t let me push you) and the therapist allows only a very small movement.

 

 Rhythmic stabilisation: Alternating isometric contractions against resistance, no motion intended.

 
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