| CTRI Number |
CTRI/2024/07/069855 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of reaching task in standing and trunk control in stroke patients |
|
Scientific Title of Study
|
Association of functional and non-functional oblique reach task with trunk control and standing postural control in stroke versus healthy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thrishala Noronha |
| Designation |
Associate Professor |
| Affiliation |
Srinivas University |
| Address |
Department of Neurorehabilitation Institute of Physiotherapy Srinivas University city campus Pandeshwar Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9743201400 |
| Fax |
|
| Email |
thrish22.cp@srinivasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Professor |
| Affiliation |
Srinivas University |
| Address |
Department of Physiotherapy Institute of Physiotherapy Srinivas University city campus Pandeshwar Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7019238290 |
| Fax |
|
| Email |
drajay@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Professor |
| Affiliation |
Srinivas University |
| Address |
Department of Physiotherapy Institute of Physiotherapy Srinivas University city campus Pandeshwar Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7019238290 |
| Fax |
|
| Email |
drajay@srinivasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Neurorehabilitation Institute of Physiotherapy Srinivas University city campus Pandeshwar Mangalore India 575001 |
|
|
Primary Sponsor
|
| Name |
Thrishala Noronha |
| Address |
Department of Neurorehabilitation Institute of Physiotherapy Srinivas University city campus Pandeshwar Mangalore India 575001 |
| 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 Thrishala Noronha |
Srinivas Institute of Physiotherapy |
Department of Neurorehabilitation Srinivas University city campus Pandeshwar Mangalore India 575001
Dakshina Kannada
KARNATAKA |
9743201400
thrish22.cp@srinivasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Trunk muscle EMG assessment in healthy |
3 hours |
| Intervention |
Trunk muscle EMG assessment in stroke |
3 hours |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. First ever supratentorial stroke
2. Medically stable and referred for Physiotherapy
3. MMSE score above 24
4. Able to use the arm to reach when standing independently
5. Able to stand for more than 2 minutes without support
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled hypertension
2. Any other musculoskeletal or neurological disorders affecting balance
3. Any structural deformities affecting the trunk, upper and lower limbs
4. On medication such as hypnotics, sedatives, antidepressants and anxiolytics
5. BMI above 25 kg/m2 and/or waist circumference above 90cm (males) and above 80cm (females)
6. Uncorrected visual problems and/or vestibular issues
7. Surgical history of spine, abdomen, upper and lower limb related conditions
8. Postural hypotension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk muscle EMG activity |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Trunk and lower limb strength
2. Trunk repositioning error
3. Standing postural control
4. Trunk control |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients will be asked to do different reaching task in the oblique direction in standing using functional and non-functional targets. During these activities, the trunk muscles activity will be recorded using wireless EMG. Additionally trunk muscle strength, lower limb muscle strength, trunk position sense, trunk control and standing postural control will be assed using tests and scales. The data collected will be compared between the tasks and also with healthy individuals to see differences. the muscle activity data will be looked for association with the secondary measures. |