| CTRI Number |
CTRI/2024/07/069788 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the efficacy of Arm Ability Training versus Task Oriented Training among Sub Acute stroke subjects. |
|
Scientific Title of Study
|
Effectiveness of Arm Ability Training versus Task Oriented Training on upper limb function and quality of life for Sub Acute stroke subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mythili D |
| Designation |
Professor |
| Affiliation |
The Tamil Nadu Dr MGR Medical University Guindy |
| Address |
Department of Physiotherapy
Neurology Division
Room No: 03
Jaya college of Paramedical sciences college of Physiotherapy Thiruninravur
Thiruvallur
TAMIL NADU
602024
India |
| Phone |
9677073534 |
| Fax |
|
| Email |
mythuphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kotteeswaran |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences Thandalam |
| Address |
Department of Physiotherapy
Orthopaedics Division
Room No: 05
Saveetha Institute of Medical and Technical Sciences
Thandalam
Thiruvallur
TAMIL NADU
602105
India |
| Phone |
9894286700 |
| Fax |
|
| Email |
kotteeswaran.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Balchandar |
| Designation |
Professor & Principal |
| Affiliation |
The Tamil Nadu Dr MGR Medical University Guindy |
| Address |
Department of Physiotherapy
Neurology Division
Room No: 01
Jaya college of Paramedical sciences college of Physiotherapy Thiruninravur
Thiruvallur
TAMIL NADU
602024
India |
| Phone |
9444011343 |
| Fax |
|
| Email |
balaisright@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaya college of Paramedical scciences, college of Physiotherapy Thirununravur 602024 |
|
|
Primary Sponsor
|
| Name |
Mythili D |
| Address |
Jaya college of Paramedical sciences college of Physiotherapy Thiruninravur 602024 |
| 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 Mythili D |
Jaya college of Paramedical sciences college of Physiotherapy Thiruninravur |
Department of Physiotherapy
Neurology Division
Room No: 10
Jaya college of Paramedical sciences college of Physiotherapy Thiruninravur
Thiruvallur
TAMIL NADU |
9677073534
mythuphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jaya College of Physiotherapy, Constitution of Institutional Human 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 |
| Comparator Agent |
Arm ability Training |
3 weeks, 5 days/ week, Each Session 60 min/ session |
| Comparator Agent |
Conventional Training |
3 weeks, 5 days/week, Each session 55 min/session |
| Comparator Agent |
Task Oriented Training |
3 weeks, 5 days/week, 50 min /session |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i BMI 24 to 29.9
ii Had a first episode of unilateral MCA stroke
iii Both Ischemic and Hemorrhagic stroke
iv Endocrine disorders like Diabetes, Hypertension
v Sub acute stroke more than 3 months
vi Person with dominant Hand involvement
vii Brunnstrom score between stages II and III for the upper extremity
viii Mini Mental State Examination score greater than or equal to 24 and 21 for illiterate
ix Able to sit independently for 30 minutes
|
|
| ExclusionCriteria |
| Details |
i Neurological disease (Parkinson’s disease, Alzhimer disease)
ii Musculoskeletal problems (deformities, recent fracture, degenerative disorders)
iii Any Systemic disease
iv Pain (score 1 or at least 2 joints)
v Aphasia
vi Patients with severe somatosensory deficit
vii Severe shoulder pain affecting therapy
viii Any comorbid condition that could limit upper extremity function
ix Visual or hearing impairment.
x Patients with repetitive stress injury
xi Patients with Psychological problem |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Graded Wolf Motor Function Test (gWMFT)
2.Gross Manual Dexterity
(Modified 9-hole peg board test with Auto-timer)
3. Triceps Skin fold Thickness
4.HRQoL: Stroke Specific quality of life questionnaire
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HRQoL: Stroke Specific quality of life questionnaire
|
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
12/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mythuphysio@gmail.com].
- For how long will this data be available start date provided 15-07-2024 and end date provided 30-06-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
This Study is a Single blinded randomized controlled trail to find the effectiveness of Arm Ability Training versus Task Oriented training on Upper limb function and Quality of life for sub-acute stroke subjects. Data samples will be collected from out patient department of Jaya college of Paramedical sciences, college of Physiotherapy, Thiruninravur. The baseline data regarding name, age, sex, stroke duration, the side of involvement, MMSE and Brunnstorm recovery stage was taken after informed consent for all subjects.
135 stroke subjects randomly allocated as Group A (Conventional Group): 45 subjects Group B (Arm Ability Training): 45 Subjects Group C (Task oriented Training): 45 Subjects.
The Anthropometric measurements includes BMI, and Triceps Skin fold Thickness. The Primary outcomes were Graded Wolf Motor Function test (Motor Functioning), Modified Nine Hole Peg Test with Auto Timer (Manual Dexterity) and Stroke Specific quality of Life ( HRQoL). The Post test scores were taken after the period of 3 weeks. The Pre and Post-test were compared. Statistical Analysis were done using Paired, Unpaired ‘t’ tests, Chi-square tests and ANOVA |