| CTRI Number |
CTRI/2020/04/024924 [Registered on: 29/04/2020] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ability of a person with one sided weakness to move their arm as compared to a healthy person. |
|
Scientific Title of Study
|
Discriminant Validity of Upper Extremity Movement Capacity in Individuals with and without Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vriddhi Vasant Shetty |
| Designation |
Pursuing MPT in Neurological Sciences |
| Affiliation |
Manipal College of Health Professions,Manipal Academy of Higher Education(MAHE) |
| Address |
Department of Physiotherapy,Manipal College of Health Professions,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9004112311 |
| Fax |
|
| Email |
vriddhishetty777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumaran D |
| Designation |
Associate Professor, Department of Physiotherapy, MCHP, MAHE |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Physiotherapy,Manipal College of Health Professions,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil Kumaran D |
| Designation |
Associate Professor, Department of Physiotherapy, MCHP, MAHE |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Physiotherapy,Manipal College of Health Professions,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
|
Source of Monetary or Material Support
|
| BeAble Health Pvt Ltd,
Center for Healthcare Enterpreneurship ,
Indian Institute of Technology - Hyderabad,
Sangareddy - Telangana - 502285
(Material Support) |
|
|
Primary Sponsor
|
| Name |
BeAble Health Pvt Ltd |
| Address |
Center for Healthcare Enterpreneurship
Indian Institute of Technology- Hyderabad
Sangareddy - Telangana -502285 |
| Type of Sponsor |
Other [Device- ArmAble] |
|
|
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 |
| Vriddhi Vasant Shetty |
Kasturba Hospital, Manipal |
Balance and Vestibular Rehab Clinic,Department of physiotherapy,1st floor, Artificial Limb Center
Udupi
KARNATAKA |
9004112311
vriddhishetty777@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital 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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
First unilateral stroke with hemiparesis/hemiplegia
Brunnstrom Motor Recovery stage ≥ 2
Medically stable patients
Patients with functional vision
Patients who can understand simple instructions and follow commands
Patients who can sit independently with or without support. |
|
| ExclusionCriteria |
| Details |
Perceptual dysfunction
Aphasia
Recent musculoskeletal injuries of the upper extremity
Shoulder subluxation
Shoulder pain
Complex Regional Pain Syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total distance covered by the upper extremity in centimeters |
One time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total duration of movement in seconds
2.Speed of movement (cm/s)
3.Movement Pattern
4.Accuracy (Number of targets reached) |
One time point |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2020 |
| 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
|
This is an observational, single center study testing discriminant validity of upper extremity movement capacity by comparing the movement capacity between individuals with and without stroke that will be conducted at Kasturba Hospital, Manipal, India. The primary outcome measure is the total distance covered by the upper extremity in centimeters. The secondary outcome measures are the total duration of movement in seconds, the speed of movement in centimetres per second, the movement pattern and the accuracy of the movement i.e. the number of targets reached. |