| CTRI Number |
CTRI/2019/08/020992 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Exercise for back muscle to improve the posture control and balance. |
|
Scientific Title of Study
|
Effects of selective pelvic and trunk Proprioceptive Neuromuscular Facilitation in acute post stroke hemiparesis-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 |
VITHOSENO IRALU |
| Designation |
MASTER OF PHYSIOTHERAPY(MPT)student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, Nitte Institute of Physiotherapy, K.S Hegde medical sciences complex, NITTE University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6296096394 |
| Fax |
|
| Email |
iraluvithoseno@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukumar S |
| Designation |
Assistant professor |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, NITTE Institute of Physiotherapy, K.S Hegde medical sciences complex, NITTE University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9611839013 |
| Fax |
|
| Email |
suku729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VITHOSENO IRALU |
| Designation |
MASTER OF PHYSIOTHERAPY(MPT)student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Ground floor, NITTE Institute of Physiotherapy, K.S Hegde medical sciences complex, NITTE University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6296096394 |
| Fax |
|
| Email |
iraluvithoseno@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, K.S Hegde hospital,Deralakatte,Mangalore-575018,Karnataka,India. |
|
|
Primary Sponsor
|
| Name |
NITTE University |
| Address |
Department of Physiotherapy,K.S Hegde Hospital,Deralakatte,Mangalore-575018,Karnataka. |
| Type of Sponsor |
Research institution and 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 |
| Vithoseno Iralu |
Justice K.S.Hegde Charitable Hospital |
Department of medicine,level-4
Dakshina Kannada
KARNATAKA |
6296096394
iraluvithoseno@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Proprioceptive neuromuscular facilitation(PNF)and truncal exercise. |
PNF technique based on rhythmic initiation,dynamic reversals,stabilizing reversals.The treatment will be given for minutes i.e.,10 minutes for each set.Both the groups will be treated for 5 days in a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants diagnosed with medial cerebral artery stroke.
2.Participants with hemiparesis.
3.Participants scoring >48 in trunk control test
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative patients
2.Participants with cognitive impairment(MMSE<24)
3.Medically unstable patients |
|
|
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 |
| Trunk Impairment Scale(TIS) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke Specific Quality Of Life Scale(SS-QOL) |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2019 |
| Date of Study Completion (India) |
05/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Early management of balance and trunk impairment is important to fasten functional recovery among patients with post stroke hemiparesis and eventhough PNF techniques are used to manage the motor dysfunction in hemiparesis there is limited and low evidence available for the hemiplegic management.Thus this randomized control trial is aiming at finding the effects of selective pelvic and trunk Proprioceptive Neuromuscular Facilitation in acute post stroke hemiparesis. |