| CTRI Number |
CTRI/2019/06/019677 [Registered on: 14/06/2019] Trial Registered Prospectively |
| Last Modified On: |
13/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between trunk control and upper limb function in chronic stroke patients. |
|
Scientific Title of Study
|
Correlation between trunk control and upper limb function in chronic stroke patients - A cross sectional analytical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Vibhute |
| Designation |
Master of Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy. Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Pune
MAHARASHTRA
411005
India |
| Phone |
9657502195 |
| Fax |
|
| Email |
nehavibhute95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajanan Bhalerao |
| Designation |
Associate Professor, Department of Neuro Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy. Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Pune
MAHARASHTRA
411005
India |
| Phone |
9822623701 |
| Fax |
|
| Email |
gajanan_bhalerao@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gajanan Bhalerao |
| Designation |
Associate Professor, Department of Neuro Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy. Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar.
Pune
MAHARASHTRA
411005
India |
| Phone |
9822623701 |
| Fax |
|
| Email |
gajanan_bhalerao@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy. Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar. |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy. Sancheti Healthcare
Academy, 111/112 Thube Park, Shivajinagar. |
| 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 |
| Neha Vibhute |
Sancheti Institute of Orthopedics & Rehabilitation |
Neuro Physiotherapy OPD, basement, SIOR, Shivaji nagar, Pune 411005
Pune
MAHARASHTRA |
9657502195
nehavibhute95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Sancheti Institute for Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of stroke with hemiplegia of 6 months or more duration |
|
| ExclusionCriteria |
| Details |
1. Any other neurological condition like cerebellar or vestibular lesion
2. Recent fracture of upper limb
3. Dislocation of shoulder
4. Diagnosed cases of shoulder hand syndrome
5. Inability to follow commands |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale |
Once at the time of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Fugl Meyer Upper Extremity Scale
2. Wolf Motor Function Scale |
1. Once at the time of assessment
2. Once at the time of assessment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Most attention is focused on impairments of extremities in a patient undergoing rehabilitation. Proximal components like trunk & their link should also be addressed. Studies on trunk control as an early predictor of overall functioning have been conducted . But whether trunk control affects upper limb function or its importance in predicting upper limb functionality has not been investigated .This trial will help us gain insight into the same by investigating how trunk control impairments correlate with objective measures of upper limb impairments & functioning. This knowledge is critical in designing a targeted rehabilitation program so that maximal functional outcomes can be achieved. |