| 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
|
|
|
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
|
|
|
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.
Top of Form
Bottom of Form
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.
Top of Form
Bottom of Form
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. |