| CTRI Number |
CTRI/2024/07/070728 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study on effect of two intervention techniques that is Proprioceptive neuromuscular facilitation technique with specific daily living task related activity training on strength of trunk muscle and functions of lower extremity in participant population who had a brain stroke. |
|
Scientific Title of Study
|
A comparative study on effectiveness of Proprioceptive neuromuscular facilitation (PNF) techniques with Task specific training on trunk control and lower extremity function in person with chronic stroke. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Vivek Chawathe |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Room number 205 physiotherapy department All India Institute of Physical Medicine and Rehabilitation K Khade Marg Hajiali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8652666514 |
| Fax |
|
| Email |
divya.savant86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Vivek Chawathe |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Room number 205 physiotherapy department All India Institute of Physical Medicine and Rehabilitation K Khade Marg Hajiali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8652666514 |
| Fax |
|
| Email |
divya.savant86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Vivek Chawathe |
| Designation |
Lecturer |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Room number 205 physiotherapy department All India Institute of Physical Medicine and Rehabilitation K Khade Marg Hajiali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
8652666514 |
| Fax |
|
| Email |
divya.savant86@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Physical medicine and Rehabilitation, K.Khade Marg, Hajiali, Mahalaxmi, Mumbai 400034 maharashtra, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Central Government Hospital] |
|
|
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 |
| Divya Vivek Chawathe |
All India Institute of Physical Medicine and Rehabilitation |
Room number 205 second floor physiotherapy department All India Institute of Physical Medicine and Rehabilitation K Khade Marg Hajiali Mahalaxmi Mumbai
Mumbai
MAHARASHTRA |
8652666514
divya.savant86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeALLINDIAINSTITUTEOFPHYSICALMEDICINEANDRRHABILITATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propriceptive Neuromuscular Facilitation Technique |
Proprioceptive Neuromuscular Facilitation Training utilizes sensory input to strengthen muscles and enhance muscle control.In this study two patterns of lower extremity flexion and extension will be use which include D1 & D2 pattern.For trunk rhythmic stabilisation pattern will be used. Duration for each session will be 45 mins per day for thrice a week for 6 weeks. |
| Comparator Agent |
Task Specific Training |
Task-specific training is used to enhance coordination and stability during activities of daily living (ADL) by repeatedly practicing these tasks.This training group include following treatment programme:-
1) Sitting on a chair and reaching for objects in all 4 directions at a distance of more than arm’s length,
2) Stepping forward, backward, and sideways on the exercise step,
3) Performing flexion and extension of the affected knee, with the affected foot located on the exercise step and the unaffected foot off the step,
4) Stepping over obstacles with different heights,
5) Standing up from a chair, walking four steps forward, touching a stool, and then returning to the chair with or without support,
6) Sitting on a Swiss ball while doing a range of motion and balance exercises in the trunk and upper extremities with support,
7) Double leg standing for 10 seconds8) Tandem standing, or placing the heel of one foot in front of the other foot, for 10 seconds,
9) Standing up from a chair without using the arms, and
10) Tandem walking forward and backward with support.
The last four exercises were performed in different situations while the somatosensory and vision were manipulated as follows:
1) With open eyes and a hard surface,
2) With open eyes and a soft surface,
3) With closed eyes and a hard surface, and
4) With closed eyes and a soft surface.
The difficulty level of the exercises was determined by increasing the number of repetitions.
Dosage of exercise:-
Exercise program will be administered to the participants of both groups 45 mins/day; 3 days a week for 6 weeks. All participants will be assessed on the day of induction of study and 6 weeks after exercise program.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Person diagnosed with first time stroke
Age group: - 18-60 years
Post stroke duration at least 6 months
Person able to do sit to stand with or without support
Person who can walk independently 10 mts with or without mobility aid
|
|
| ExclusionCriteria |
| Details |
uncontrolled cardiovascular parameter |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trunk impairment scale and
Fugl meyer scale for lower extremity |
Day 1 and after 6th week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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
|
This is a comparative study on effectiveness of proprioceptive neuromuscular facilitation with task specific training on trunk control and lower extremity function in person with chronic stroke. Aim of the study is to find which therapy approach is better amongst selected two approaches in chronic stroke population. this is randomized control trial done by using convenience sampling method to allocate the participants in two therapy groups after receiving their consents .Therapy dosage will be 45 mins/day for thrice a week for 6 weeks, trunk control and lower extremity functions will be using trunk impairment scale and Fugl Meyer scale for lower extremity as primary outcome measure on first day of study and after 6 weeks of intervention. Pre and post data will be assessed for statistical significance at 95% level of significance. |