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CTRI Number  CTRI/2024/09/074001 [Registered on: 18/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
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   Efficacy of dynamic neuromuscular stabilization technique versus pelvic proprioceptive neuromuscular facilitation technique on stroke patients 
Scientific Title of Study   Efficacy of dynamic neuromuscular stabilization technique versus pelvic proprioceptive neuromuscular facilitation technique on dynamic trunk balance of patients with chronic stroke 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Manali Sonawane 
Designation  PG Student 
Affiliation  Lovely Professional University  
Address  Room no 105, LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab.

Kapurthala
PUNJAB
144411
India 
Phone  9579513627  
Fax    
Email  manalisonawane1502@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manju Devi  
Designation  Assistant Professor 
Affiliation  Lovely Professional University 
Address  Cabin 7, Room 213, Block 4, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab.

Kapurthala
PUNJAB
144411
India 
Phone  9056382268  
Fax    
Email  manju.23207@lpu.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Manju Devi  
Designation  Assistant Professor 
Affiliation  Lovely Professional University 
Address  Cabin 7, Room 213, Block 4, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab.

Kapurthala
PUNJAB
144411
India 
Phone  9056382268  
Fax    
Email  manju.23207@lpu.co.in  
 
Source of Monetary or Material Support  
Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab, India. 
 
Primary Sponsor  
Name  Manali Sonawane 
Address  Room no 105, LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab. 
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 Manali Sonawane PT  Lovely Professional University  Room no 105, LPU OPD, block 3, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru, Phagwara-144411, Punjab.
Kapurthala
PUNJAB 
09579513627

manalisonawane1502@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (LPU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dynamic Neuromuscular Stabilization.   Dynamic Neuromuscular Stabilization (DNS) is a therapeutic approach that focuses on optimizing the bodys neuromuscular function. It integrates principles from developmental kinesiology, which examines how movement patterns evolve from infancy to adulthood. This method seeks to activate the deep stabilizing muscles, improve coordination, and support functional movement. DNS aims to restore and enhance core stability, improve posture, and optimize movement patterns by retraining the bodys stabilizing muscles to function correctly. This technique will be given for 30 min, 3 alternate days a week for a total duration of 4 weeks (12 sessions). This will include the protocol that will consists of 12 developmental pattern exercises that involve reflex-mediated diaphragm facilitation.  
Intervention  Pelvic Proprioceptive neuromuscular facilitation intervention.  Pelvic Proprioceptive Neuromuscular Facilitation (PNF) is a therapeutic technique designed to improve pelvic stability and function through targeted movements and muscle activation. This technique will be given for 30 min, 3 alternate days a week for a total duration of 4 weeks (12 sessions). These procedures will be done to facilitate anterior elevation and posterior depression, posterior elevation and anterior depression of pelvis in a side lying position on affected side. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Chronic stage of stroke.
2. Left or right hemiplegic stroke.
3. 45-65 years.
4. male and female participants.
5. Comprehend and able to follow commands. 
 
ExclusionCriteria 
Details  1. cognitive dysfunction.
2. Neurological abnormalities such as Dementia, Alzheimer’s disease.
3. Unstable medical condition.
4. Respiratory disorders and cardiac disorders.
5. Fixed deformities and contractures.
6. Enrolled in different clinical trials.
7. Unwilling or refused to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Trunk Impairment Scale (TIS)
2. Tinetti Test 
T1 and T2
T1- Pre intervention (baseline)
T2 Post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Stroke-specific Quality of life scale (SS-QOL)  T1 and T2
T1- Pre intervention (baseline)
T2 Post intervention 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   04/10/2024 
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="1"
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  

After evaluating the subjects based on the inclusion and exclusion criteria, those who qualify will be enrolled in the study. Participants will then fill out a consent form and be provided with a detailed explanation of the procedure.

Participants will be assigned to one of two groups: either the Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Group (Group A) or the Dynamic Neuromuscular Stabilization (DNS) Group (Group B) using computer-generated purposive sampling. Each group will receive instructions on how to perform the exercises and how the testing will be conducted. Prior to the commencement of the protocol, the subjects will be assessed using various outcome measures, including the Trunk Impairment Scale (TIS), Stroke-Specific Quality of Life Scale (SS-QOL), Berg Balance Scale, and Tinetti Test.

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Group A– Experimental group-

Subjects in Group A will receive a protocol of Pelvic PNF for 30 minutes, 3 alternate days a week for a total duration of 4 weeks (12 sessions) following conventional therapy. Each technique will be given for 10 minutes. These procedures will be conducted to facilitate anterior elevation and posterior depression, as well as posterior elevation and anterior depression of the pelvis in a side-lying position on the affected side. Appropriate rest time will be provided to each patient in between the protocol according to the patients’ comfort. The elements of PNF, such as manual contact, stretch, resistance, and verbal cuing, will be incorporated into the treatment scheme.

Group B - Experimental Group

Subjects in Group B will receive a combined therapy of DNS and conventional physiotherapy, which will include trunk, pelvis, and lower limb training. DNS will include several developmental pattern exercises where the therapist will position their thumbs on the chest area and encourage regular breathing patterns while supporting the descent of the diaphragm to engage its stabilizing function. The DNS treatment will involve a protocol consisting of 12 developmental pattern exercises that engage reflex-mediated diaphragm facilitation. This will activate the core stabilizers by positioning the vertebral column, ribcage, pelvis, and scapula in alignment. For the first week, two to three developmental positions will be implemented to teach appropriate breathing patterns and stabilization. Over the following three weeks, three to four new patterns from the DNS techniques will be introduced. By the end of the fourth week, participants will be expected to successfully practice all the patterns illustrated in the DNS. This will include diaphragmatic breathing, the three-month supine position with hips, knees, and ankles at 90-degree flexion, the prone three-month position with upper arms at a 90-degree angle to the trunk, supported on elbows, and the side-lying 5th-month position where the patient will lie on the side with the lower shoulder supported, elbow flexed, wrist in a neutral position, and the lower limb supported in a semi-flexed position at the knee, aligning the heel and hip with the ischial tuberosity. Treatment will be provided for 30 minutes, 3 alternate days a week for a total duration of 4 weeks (12 sessions) following conventional therapy.

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Conventional exercises for both the groups will include the active range of motion (ROM) exercises, stretching of the tightened muscles, mat exercises for stability, functional training for ADL.

 
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