| CTRI Number |
CTRI/2024/05/067887 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| 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
|
Advance physiotherapy treatment to improve, stability and walking in people with stroke. |
|
Scientific Title of Study
|
Effectiveness of Neurodevelopmental therapy on Pelvic alignment , Trunk control and Gait Parameters in Chronic Stroke Individuals : A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayashree Suvarna |
| Designation |
post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, Second base division,Nitte Institute of Physiotherapy, NITTE (Deemed to be University) Deralakatte, Mangaluru , Dk
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6363934508 |
| Fax |
|
| Email |
jaya06suvarna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Associate professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, Second base division,Nitte Institute of Physiotherapy, NITTE (Deemed to be University) Deralakatte, Mangaluru , Dk
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Associate professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, Second base division,Nitte Institute of Physiotherapy, NITTE (Deemed to be University) Deralakatte, Mangaluru , Dk
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, NITTE(Deemed to be university) Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru, 575018 D.K , karnataka, India, will provide basic infrastructure facilities. no other monetory support required. |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, Second base division,Nitte Institute of Physiotherapy, NITTE (Deemed to be University) Deralakatte, Mangaluru , Dk |
| Type of Sponsor |
Other [constituent physiotherapy institute of Nitte (deemed to be university)] |
|
|
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 Krishna Kovela |
Justice K S Hegde Charitable Hospital |
Department of Physiotherapy, Room number 20, Second base division, Justice K S Hegde Charitable Hospital, Medical Science Complex, University Road, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
7204346274
rakesh.krisjna@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee of Nitte institute of Physiotherapy |
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 |
Conventional therapy |
Active range of motion, passive range of motion, stretching exercise, progressive resistive exercise 2 rounds with 10 repetition for 5 days in a week for 4 weeks. |
| Intervention |
Neurodevelopmental Therapy in Chronic Stroke Individuals |
Experimental group will receive the neurodevelopmental therapy for pelvis alignment, trunk control and gait parameters for 30 minutes for 5days in a week for 4 weeks and control group will receive the standard conventional therapy 2 rounds with 10 repetition for 30 minutes for 5 days in a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient diagnosed with 1st time stroke irrespective of their gender between the age group of 40 to 60years,chronic stroke, MMSE more than 23, able to walk with or without walking aids. |
|
| ExclusionCriteria |
| Details |
Patient with any other musculoskeletal or neurological disorder
Fixed deformity of the spine and lower extremity
Cardiorespiratory disorders
brain stem or cerebellar lesions.
|
|
|
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
Palpation meter
Gait parameters |
1st day (preintervention)
last day (post intervention)of 4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini Mental State Examination (MMSE) |
Assessed on the first day of the Intervention & last day of the Intervention. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
27/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neurodevelopment therapy is considered to be effective in improving trunk control and gait parameters. This study focuses on effectiveness of neurodevelopmental therapy on trunk control, pelvic alignment and gait parameters on chronic stroke population. Control group will be given as a standard care for 30 minutes for 5days in a week for 4 weeks. The experimental group will be given neurodevelopmental therapy for 30 minutes and standard conventional therapy for 30 minutes. Neurodevelopmental therapy is incorporated for trunk , pelvis alignment and gait parameters . Pre-evaluation will be done on 1st day and post evaluation done on last day of 4th week. |