| 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
|
|
|
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
|
|
|
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. |