| CTRI Number |
CTRI/2024/08/072650 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| 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
|
Effectiveness of PNF Vs CIMT on Balance and Gait in Stroke Patients |
|
Scientific Title of Study
|
To Compare the Effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) Versus Constraint Induced Movement Therapy (CIMT) on Balance and gait in Stroke Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidisha Sharma |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi Physiotherapy college, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road, jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9462013945 |
| Fax |
|
| Email |
vidisha1978@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Neurology physiotherapy lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road, jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9928428453 |
| Fax |
|
| Email |
drkneurophysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Khandelwal |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Neurology physiotherapy lab,Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road, jaipur
Jaipur
RAJASTHAN
302031
India |
| Phone |
9928428453 |
| Fax |
|
| Email |
drkneurophysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road,Jaipur, Rajasthan (India), 302022 |
|
|
Primary Sponsor
|
| Name |
Vidisha Sharma |
| Address |
1282, Gopal ji ka Rasta, Mahadev Johari ki Gali, Johari Bazaar, Jaipur, Rajasthan, India, 302003 |
| 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 Rakesh Khandelwal |
Mahatma Gandhi Hospital,Jaipur |
Room no. 14 Physiotherapy OPD, Basement.
Jaipur
RAJASTHAN |
9928428453
drkneurophysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma GAndhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Constraint Induced Movement Therapy (CIMT) |
Modified CIMT (m-CIMT) will be performed in this study without restricting the non-
paretic limb but encouraging the patients to use the paretic limb, and by reducing the
rigorous practice schedule.
Under the m-CIMT following activities will be performed:
1. sit to stand transfers by using a suitable chair (controlling the position of the
paretic leg), 5–10 times per day and progressing as per need.
2. Indoor walking training under physical therapy guidance, 5-7 min and progressing
as per need.
3. climbing up and down stairs training for 5-7 steps/time and progressing as per
need.
4. Balance training
5. One leg weight training on paretic and non-paretic leg
6. Muscle strength training
Progression as per need.
Duration of treatment will be 45-60 min including 6 min of rest period in between as per
the patients requirement, for 5 days a week for a total duration of approximately 4 weeks. |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
1. Rhythmic initiation
2. Combination of Isotonics (Reversal of Agonists)
3. Reversal of Antagonists
a. Dynamic reversal of antagonists
b. Stabilizing reversal
c. Rhythmic stabilization
Duration of treatment will be 45-60 min including 6 min of rest period in between as per
the patients requirement, for 5 days a week for a total duration of approximately 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with MCA non-traumatic ischemic infarction during Recovery Stage |
|
| ExclusionCriteria |
| Details |
1. Patients with severe disabling arthritis
2. Patients with any cognitive dysfunction.
3. Any other cardiopulmonary deficits.
4. Any other neurological deficits involving sensory function.
5. Any other musculoskeletal disorder of lower extremity.
6. Patients currently undergoing any gait training exercises.
7. Patient who did not consent for follow up |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Berg Balance Scale (BBS)
2. 10 Meter Walk Test (10MWT) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Berg Balance Scale (BBS)
2. 10 Meter Walk Test (10MWT) |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Subjects of Group A will receive Proprioceptive Neuromuscular Facilitation (PNF). Under PNF following techniques will be given 1. Rhythmic initiation 2. Combination of Isotonics (Reversal of Agonists) 3. Reversal of Antagonists a. Dynamic reversal of antagonists b. Stabilizing reversal c. Rhythmic stabilization 4. Repeated Stretch (Repeated Contraction) Duration of treatment will be 45-60 min including 6 min of rest period in between as per the patients requirement, for 5 days a week for a total duration of approximately 4 weeks. Subjects of Group B will receive Constraint Induced Movement Therapy (CIMT). Modified CIMT (m-CIMT) will be performed in this study without restricting the non- paretic limb but encouraging the patients to use the paretic limb, and by reducing the rigorous practise schedule. Under the m-CIMT following activities will be performed: 1. sit to stand transfers by using a suitable chair (controlling the position of the paretic leg), 5–10 times per day and progressing as per need. 2. Indoor walking training under physical therapy guidance, 5-7 min and progressing as per need. 3. climbing up and down stairs training for 5-7 steps/time and progressing as per need. 4. Balance training 5. One leg weight training on paretic and non-paretic leg. 6. Muscle strength training Progression as per need. Duration of treatment will be 45-60 min including 6 min of rest period in between as per the patients requirement, for 5 days a week for a total duration of approximately 4 weeks |