| CTRI Number |
CTRI/2025/05/087976 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of technology to improve the hand movements among neuro patients |
|
Scientific Title of Study
|
Effectiveness of Mobile App Based Exercises on Hand Function among Subjects with MCA Stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
priyadharshini kumar |
| Designation |
Lecturer |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5A4, 5th floor Health Science Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences Saveetha Nagar, Thandalam Chennai, Kancheepuram.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9790865258 |
| Fax |
|
| Email |
physiopriyadharshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vignesh Srinivasan |
| Designation |
Associate Professor |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
Room A5, 5th floor Health Science Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Kancheepuram.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7338753358 |
| Fax |
|
| Email |
vigneshphysio1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
priyadharshini kumar |
| Designation |
Lecturer |
| Affiliation |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5A4, 5th floor Health Science Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences saveetha nagar thandalam chennai kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9790865258 |
| Fax |
|
| Email |
physiopriyadharshini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences |
| Address |
Room No E4 Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences Saveetha Nagar Thandalam Chennai 602105 |
| 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 |
| Dr Priyadharshini Kumar |
Saveetha College of Physiotherapy |
Room No E4 Saveetha College of Physiotherapy Saveetha Institute of Medical and Technical Sciences Saveetha Nagar Thandalam Chennai 602105
Kancheepuram
TAMIL NADU |
9790865258
physiopriyadharshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active hand exercises |
5 days per week for 6 weeks |
| Intervention |
Mobile app-based exercises |
5 days per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
middle cerebral artery stroke
less than 6 months of stroke onset
dominant hand paralysis
participants with burnnstrom stage of recovery grade 3 and above
medically stable enough to participate in active rehabilitation
fuglmeyer upper extremity motor score 21 to 56
mini mental status examination score 25 and above
|
|
| ExclusionCriteria |
| Details |
participants with hearing and visual impairment
patient history of traumatic injury
systemic and psychiatric illness
stroke subjects with other artery involvement
participant with recurrent stroke and other neurological disorders
participant with other musculoskeletal disorders
red flag signs as tumour cancer severe osteoporosis
participation in other trials
|
|
|
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 |
Hand dynamometer
Pinch meter
Fugl Meyer Assessment for Upper Extremity |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Magnetic Resonance Imaging |
At the end of 6 weeks for 5 particpants from experimental group |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
15/07/2025 |
| 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
study will be conducted to evaluate the effectiveness of mobile app-based
exercises on hand function among subjects with middle cerebral artery stroke.
after
getting institutional ethical approval, the study will be carried out. based on
selection criteria 57 participants will be recruited, from the physiotherapy opd
and ipd will be involved in this study. subjects will be explained about safety
and simplicity of the research procedure purpose and duration. the informed
consent and information sheet will be obtained. included participants will be undergoing pretest measures such as hand
dynamometer pinch meter fugl meyer assessment for upper extremity.after
completion of the pre-test participants will be allocated in to two groups by
concealed envelope method as experimental group sample is 27 and control group
sample is 27. experimental group will receive mobile app-based exercises.participants in this
group would perform hand function exercises using a mobile app designed
specifically for stroke rehabilitation. the app might include hand movements
or tasks to improve fine motor skills pinch strength grip strength or dexterity with real-time
feedback from the app. the session will be for 5 days per week for 6 weeks.
control
group
this group would receive traditional hand therapy exercises manual
exercises for hand function such as gripping pinching or squeezing objects. range
of motion exercises passive or active stretching exercises for fingers wrist and
hand. simple everyday activities like using eating utensils or opening jars to
mimic daily functions. the session will be for 5 days per week for 6 weeks.pre and post test fmri will be done for 5
participants from mobile app based rehabilitation group to assess
neuroplasticity.the values will be tabulated and statistically analyzed.
staistical analysis of
this phase
hand
dynamometer within the
group paired t test between the
groups independent t test
pinch
meter
within the
group paired t test
between the
groups independent t test
fugl
meyer assessment for upper extremity
within the
group wilcoxon signed rank test
between the
group mann whitney u test
fmri
paired‘t test.
the values will be
tabulated and statistically analyzed. |