| CTRI Number |
CTRI/2019/03/018044 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
08/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
PNF in hand opening for stroke individuals. |
|
Scientific Title of Study
|
EFFECTIVENESS OF PROPRIOCEPTIVE
NEUROMUSCULAR FACILITATION (PNF) ON
HAND OPENING IN STROKE INDIVIDUALS- A
RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maitri Rajyaguru |
| Designation |
Post graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
NITTE INSTITUTE OF PHYSIOTHERAPY,
K.S HEGDE MEDICAL ACADEMY CAMPUS,DERLAKATTE,POST NITHYANAND NAGAR
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7878079217 |
| Fax |
|
| Email |
maitri0rajyaguru@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukumar S |
| Designation |
assistant proffessor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
NITTE INSTITUTE OF PHYSIOTHERAPY,
K.S HEGDE MEDICAL ACADEMY CAMPUS,DERLAKATTE,POST NITHYANAND NAGAR
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9482254497 |
| Fax |
|
| Email |
suku729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maitri Rajyaguru |
| Designation |
Post graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
NITTE INSTITUTE OF PHYSIOTHERAPY,
K.S HEGDE MEDICAL ACADEMY CAMPUS,DERLAKATTE,POST NITHYANAND NAGAR
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7878079217 |
| Fax |
|
| Email |
maitri0rajyaguru@gmai.com |
|
|
Source of Monetary or Material Support
|
| K.S HEGDE MEDICAL HOSPITAL
DERLAKATTE
MANGALORE |
|
|
Primary Sponsor
|
| Name |
MAITRI RAJYAGURU |
| Address |
DERLAKATTE, MANGALORE |
| 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 |
| MAITRI RAJYAGURU |
K.S HEGDE MEDICAL HOSPITAL |
FLOOR 5, DEPARTMENT OF MEDICINE
Dakshina Kannada
KARNATAKA |
7878079217
maitri0rajyaguru@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: I688||Other cerebrovascular disorders indiseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
STRETCHING
ACTIVE RANGE OF MOTION
PASSIVE RANGE OF MOTION
WEIGHT BEARING
BALANCE
COORDINATION |
| Intervention |
INTERVENTION GROUP |
PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION OF UPPER LIMB-
COMBINATION OF ISOTONOCS
DYNAMIC REVERSALS
STABILIZING REVERSALS |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
hemipaeretic post stroke patients
brunstorm recovery stage at least 3
patients having first episode of stroke
duration less than 3 months
MMSE>25 points |
|
| ExclusionCriteria |
| Details |
related orthopedic conditions
surgeries before 3 months affecting hand functions
diabetic neuropathy
psychiatric patients
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
BOX AND BLOCKS TEST
ACTION RESEARCH ARM TEST
MODIFIED RANKIN TEST |
BEFORE STARTING TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BOX AND BLOCKS TEST
ACTION RESEARCH ARM TEST
MODIFIED RANKIN TEST |
AFTER 4 WEEKS OF INTERVENTION |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 |
|
Date of First Enrollment (India)
|
17/04/2019 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is done to evaluate the effectiveness of Proprioceptive Neuromuscular Facilitaion on hand opening in stroke individuals. stroke paatients will be screened according to the inclusion criteria of the study, screened patients will be given consent forms,then they will be randomized in two groups before starting with the treatment the three outcome measures will taken, the treatment has to be given for 30 minutes in each group for 5 days per week for 4 weeks, then outcome measures will be taken again. |