| CTRI Number |
CTRI/2018/02/011894 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/02/2018 |
| 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
|
Effect of proprioceptive neuromuscular facilitation and truncal exercises on trunk control and dynamic sitting balance in post stroke subjects |
|
Scientific Title of Study
|
Efficacy of Proprioceptive Neuromuscular Facilitation (PNF) and truncal exercises on trunk control and dynamic sitting balance in post stroke subjects : A 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 |
Anjali Tiwari |
| Designation |
post graduate student |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy, KMC Mangalore,Manipal Academy Of Higher Education, Dakshina Kannada,
Karnataka.
575003
India
Department of Physiotherapy,KMC Mangalore,Manipal Academy Of Higher Education, Dakshina Kannada, Karnataka.
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8105730670 |
| Fax |
|
| Email |
anjalitiwarinaina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Vijay Kumar |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy KMC Mangalore, Manipal Academy Of Higher Education, Dakshina Kannada
KARNATAKA
575001
India
Department of Physiotherapy KMC Mangalore,Manipal Academy Of Higher Education, Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9980189597 |
| Fax |
|
| Email |
vijaykmcmangalore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vijay Kumar |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical college |
| Address |
Department of Physiotherapy KMC Mangalore,Manipal Academy Of Higher Education, Dakshina Kannada
KARNATAKA
575001
India
Department of Physiotherapy KMC Mangalore, Manipal Academy Of Higher Education,Dakshina Kannada
KARNATAKA
575001
India
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9980189597 |
| Fax |
|
| Email |
vijaykmcmangalore@gmail.com |
|
|
Source of Monetary or Material Support
|
| manipal university, mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy KMC, Mangalore Light House Hill road,
Hampankatta, Mangalore Karnataka Dakshina Kannada
KARNATAKA 575001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Anjali Tiwari |
KMC Hospitals, Mangalore |
5th floor, Dept of physi
otherapy,Ambedkar
circle. OPD-3, 2nd floor,
Dept of
physiotherapy,Attavar.
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
8105730670
anjalitiwarinaina@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 |
Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propriceptive neuromascular facilitation for trunk control |
proprioceptive neuromascular facilitation excercises includes diagonal pattern procedure and technique to stimulate proprioceptive sensation either to inhibit or to simulate specific muscle groups. |
| Comparator Agent |
Truncal excercises |
Exercises designed to improve trunk control by using stable and unstable surface. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. First onset of acute stroke patient’s diagnosis confirmed by neurologist or physician and further referred to department of physiotherapy for stroke rehabilitation.
2. Subjects with supratentorial lesion.
3. MMSE score ≥ 24(Appendix VI).
4. Trunk Control Test score equal to 100.
|
|
| ExclusionCriteria |
| Details |
1. Subject with cerebellar and brainstem stroke.
2.Subject having other neurological disorder eg. Parkinson’s disease
3.Subjects having general musculoskeletal conditions which is limiting subjects performance in the outcome measure/ treatment protocol.
4. Subject with hemi neglect, pusher’s syndrome, severe visual field defects and somato-sensory deficit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trunk Impairment Scale (TIS) by Verheyden will be considered for the primary outcome measure to address trunk control.
|
pre intervention and post intervention (10 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Function in sitting balance test to measure dynamic sitting balance.
Functional independence measure to measure the activity of daily living.
Patient global impression of Change scale –A subjective measure to quantify the change produce by intervention. |
pre treatment and post treatment after 10 sessions |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
23/01/2017 |
| Date of Study Completion (India) |
31/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
On approval, subjects who are referred for stroke rehabilitation will be approached and detail of the study will be explained to the subjects . Informed consent form (Appendix II) will be obtained from the interested participant and screening will be done based on study criteria. Following that selected subjects will be randomly allocated in group A and group B, Group A will receive truncal exercise and group B participants will receive PNF exercise. Block size of 4 will be used in this trial to allocate subjects to two groups, i.e. 2 truncal exercise intervention and 2 PNF exercise intervention in each block. Allocation concealment will be done using sealed opaque envelops which will be sequentially arranged. Participant of Group A will receive 30 minutes of truncal exercise on stable and unstable surface . The stable surface (plinth) exercises include bridging, unilateral bridging, and truncal rotation. Depending on subject’s performance, the exercises will be progressed towards unstable surface (Physio ball).
Participant of group B will receive 30 minutes of PNF exercises which will include PNF techniques such as rhythmic initiation, rhythmic stabilization and slow reversal to facilitate trunk control.
A total of 10 sessions for 2 weeks with each session lasting approximately for 30 minutes. |