| CTRI Number |
CTRI/2024/09/074310 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving hand functions in stroke patients using a carriable box that mimics usual daily tasks. |
|
Scientific Title of Study
|
Effect of Task-Oriented Training Using a Portable Exercise Kit for Hand Function Among
Patients with subacute Stroke: 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 |
Nihala Parveen M |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
MPT 1st year classroom, MPT Divsion,
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018.Dakshina Kannada, KARNATAKA
,India
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018. Dakshina Kannada KARNATAKA
,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6238358941 |
| Fax |
|
| Email |
nihalaparveenclt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha D |
| Designation |
AdditionalProfessor |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Vice principal room, Staff Division,
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018.Dakshina Kannada KARNATAKA
,India
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018.Dakshina Kannada KARNATAKA
,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886318394 |
| Fax |
|
| Email |
Smithad@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nihala Parveen M |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
MPT 1st year classroom, MPT Division.
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018.Dakshina Kannada, KARNATAKA, India
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018.Dakshina Kannada, KARNATAKA, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6238358941 |
| Fax |
|
| Email |
nihalaparveenclt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self source / Yenepoya ayurveda Medical college and hospital (YAMCH) |
|
|
Primary Sponsor
|
| Name |
Nihala Parveen M |
| Address |
Yenepoya Physiotherapy College. Naringana, Deralakatte
Mangalore - 575018. Karnataka Dakshina Kannada KARNATAKA
575018 India |
| 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 |
| Nihala Parveen M |
Yenepoya ayurveda medical College and hospital (physiotherapy department) |
Yenepoya ayurveda medical College and hospital(YAMCH), manglore Karnataka
Dakshina Kannada
KARNATAKA |
6238358941
nihalaparveenclt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Participants of control group receive upper extremity conventional physiotherapy such as range of motion exercise and mobilization for 40 minutes a session, 4 days per week , total of 4 weeks. |
| Intervention |
Task oriented training usinga portableexercise kit. |
Construction of portable kit , that will include objects required to perform task oriented training focusing on hand functions. Participants of intervention group receive conventional physiotherapy along with the task-oriented training using portable kit for 40 minutes a session , for 4 times per week and total of 4-weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Single unilateral CVA (both ischemic and hemorrhagic).
b. Duration of stroke: Subacute
c. Brunnstrom stage of stroke recovery 4 or more.
d. Mini Mental state examination score 24 or more. |
|
| ExclusionCriteria |
| Details |
Neurological disorders other than stroke
Musculoskeletal conditions like recent fracture
Visual problem that could not be corrected
Unilateral neglect
Non cooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wolf motor function test
Hand dynamometer |
Baseline and Post intervention (After 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The aim of the study is " To evaluate the effect of task-oriented training using a portable exercise kit on hand function among patients with subacute stroke".Total sample size of the study is 26, 13 subjects must be included in each group.The subjects who fulfil the inclusion and exclusion criteria, the baseline assessment will be taken only after explaining the study procedure and signing informed consent. Then the participants will be randomly allocated to the experimental and control groups using simple randomization (computer-generated randomization). Both groups will be receiving intervention for 40 minutes a session, 4 days per week for 4 weeks. The control group will be receiving conventional physiotherapy such as mobilizations, stretching, range of motion exercise and strengthening (using weight cuff or TheraBand). The experimental group will receive 15-minutes of conventional physiotherapy and 25-minutes of task-oriented training for using this portable exercise kit that include all the objects which is mentioned in phase-1 for hand function. The post-assessment will be taken for all outcome measures after 4 weeks of training. |