| CTRI Number |
CTRI/2022/06/043037 [Registered on: 06/06/2022] Trial Registered Prospectively |
| Last Modified On: |
22/05/2022 |
| 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
|
To study the effectiveness and to compare the three approaches (DNS, NDT, PNF) used to treat paralysis patient. |
|
Scientific Title of Study
|
Effectiveness of Dynamic Neuromuscular Stabilization, Neurodevelopmental techniques and Proprioceptive Neuromuscular Facilitation on Trunk and Gait parameters in patients with subacute stroke, A Three arm Parallel randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swadha P Udhoji |
| Designation |
MPT Student |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7738657580 |
| Fax |
|
| Email |
swadhamushriff@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Professor |
| Affiliation |
Datta meghe Institute of Medical Sciences |
| Address |
Department of Neuropphysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakeshkrishna.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Professor |
| Affiliation |
Datta meghe Institute of Medical Sciences |
| Address |
Department of Neuropphysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakeshkrishna.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College , Acharya Vinoba Bahave Rural Hospital, Datta Meghe Institute Of Medical Sciences Sawangi Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Medical Sciences |
| Address |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy college sawangi Wardha Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swadha P Udhoji |
Acharya Vinoba Bhave Rural Hospital |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Sawangi Wardha
Wardha
MAHARASHTRA |
7738657580
swadhamushriff@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, (2) ICD-10 Condition: G99||Other disorders of nervous systemin diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dynamic Neuromuscular Stabilization, Neurodevelopmental Technique, Proprioceptive Neuromuscular Facilitation |
Dynamic Neuromuscular Stabilization DNS (Dynamic Neuromuscular Stabilization) is a new rehabilitation concept developed by Professor Pavel Kolar after being inspired by Vojtas work on reflex locomotion (RL).The Integrated spinal stabilisation system (ISSS) is formed by the exact co-activation of the intrinsic muscles of the spine, which includes the cervical extensors and flexors, diaphragm, transverses abdominis muscle, pelvic floor and multifidus. This concept is based on developmental kinesiology (DK), which emphasises the presence of central movement patterns at birth. Neurodevelopmental Technique This is widely used treatment after stroke. These are the certain set of activities, but principle oriented neuro rehabilitation and in which proper patterns and stimulation is done in a care based manner, and the optimal usage of patients brain neuroplasticity, the avoidance of compensatory mechanisms, and the patients maximal independence in everyday activities. Propriceptive Neuromuscular facilitation It is a technique which works on the basis of concept, Increased voluntary responses are achieved when movement patterns are combined with other facilitative processes. PNF therapy is based on early evolutionary and embryologic discoveries that movement happens from the upper to the lower body parts. As a result, trunk gains the control over the extremities.
The three approaches will be given for 45 min. a day for 5 days a week for 4 weeks . |
| Intervention |
Dynamic Neuromuscular stabilization,Neurodevelopmental technique, Proprioceptive Neuromuscular facilitation |
Dynamic Neuromuscular Stabilization
DNS (Dynamic Neuromuscular Stabilization) is a new rehabilitation concept developed by Professor Pavel Kolar after being inspired by Vojtas work on reflex locomotion (RL).The Integrated spinal stabilisation system (ISSS) is formed by the exact co-activation of the intrinsic muscles of the spine, which includes the cervical extensors and flexors, diaphragm, transverses abdominis muscle, pelvic floor and multifidus. This concept is based on developmental kinesiology (DK), which emphasises the presence of central movement patterns at birth.
Neurodevelopmental Technique
This is widely used treatment after stroke. These are the certain set of activities, but principle oriented neuro rehabilitation and in which proper patterns and stimulation is done in a care based manner, and the optimal usage of patients brain neuroplasticity, the avoidance of compensatory mechanisms, and the patients maximal independence in everyday activities.
Propriceptive Neuromuscular facilitation
It is a technique which works on the basis of concept, Increased voluntary responses are achieved when movement patterns are combined with other facilitative processes. PNF therapy is based on early evolutionary and embryologic discoveries that movement happens from the upper to the lower body parts. As a result, trunk gains the control over the extremities. The intervention in the each groups will be given for 45 min a day for 5 days, per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 40yr to 65yr with either gender. Those persons who can to understand, communicate and follow the instructions and those persons with Sub acute stroke. |
|
| ExclusionCriteria |
| Details |
Patients who has Severe cardiac illness, Patients those are having fracture and patients with recurrent stroke |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIS DGI Gait Parameters |
All the outcome measures will be assessed on day 1 pre treatment and after 4 weeks post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMSE, VCG, MAS |
all the secondary outcome measure will be assessed on the day 1 and after 4 weeks post intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study intends to determine the effectiveness of all the three approaches individually and to compare the effectiveness of DNS, NDT and PNF on trunk and gait parameters. Furthermore the findings of this study could be used to assist post stroke survivors in their early recovery and improve their level of independence.After the study conducted conclusion will be drawn that which treatment is most suitable among all the proven techniques and will be helpful in treating stroke . |