| CTRI Number |
CTRI/2025/11/097225 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| 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 Compare Arm Ability Training with Rhythmic Auditory Stimulation Versus Task Oriented Training With Rhythmic Auditory Stimulation for sub acute Stroke Subjects |
|
Scientific Title of Study
|
To compare the effectiveness of Arm Ability Training with rhythmic auditory stimulation Versus Task Oriented Training with Rhythmic Auditory Stimulation to improve upper limb dexterity and quality of life in sub-acute stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Mythili |
| Designation |
Research Scholar |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Physiotherapy department, Neurology division,room no 03 Saveetha Institute of Medical and Technical Sciences
Saveetha University
Thandalam
Thiruvallur
TAMIL NADU
602105
India |
| Phone |
9677073534 |
| Fax |
|
| Email |
drmythuphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kotteeswaran |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Physiotherapy department, Neurology division,Room no 03 Saveetha Institute of Medical and Technical Sciences
Saveetha University
Thandalam
Thiruvallur
TAMIL NADU
602105
India |
| Phone |
9894286700 |
| Fax |
|
| Email |
kotteeswaran.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
D Mythili |
| Designation |
Research Scholar |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Physiotherapy department, Neurology division,Room no 03 Saveetha Institute of Medical and Technical Sciences
Saveetha University
Thandalam
Thiruvallur
TAMIL NADU
602105
India |
| Phone |
9677073534 |
| Fax |
|
| Email |
drmythuphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaya College of Physiotherapy, Thiruninravur 602 024 |
|
|
Primary Sponsor
|
| Name |
The Tn Dr MGR Medical University |
| Address |
No 69 Anna Salai
Guindy
Chennai 600032 |
| Type of Sponsor |
Government funding agency |
|
|
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 Balchandar V |
Jaya college of Physiotherapy |
Room 1
Physiotherapy Department
Paramedical Sciences Division
Jaya College of Physiotherapy
CTH Road
Thiruninravur 602 024
Thiruvallur
TAMIL NADU |
9444011343
balaisright@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jaya College of Paramedical Sciences College of Physiotherapy Insitutional Human Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm ability training with Rhythmic Auditory Stimulation |
3 weeks, 5 days/ week, Each Session 60 min/ session
The purpose of AAT is to assist stroke patients with mild to moderate arm paresis in regaining their manual dexterity. The training was designed to target various capacities offered the possibility that gain or improve in motor skills would also result in improvement in motor performance under various conditions or circumstances
Through the auditory system, RAS affects or influence the temporal lobe. When the brain’s internal timing system is compromised, auditory rhythm serves as a potent sensory cue that can control motor timing and coordination. It is interesting to note that mature brain neuroplasticity changes occur when motor and musical training are combined |
| Comparator Agent |
Arm ability training with Rhythmic Auditory Stimulation vs Task oriented training with Rhythmic Auditory Stimulation |
NA |
| Intervention |
Task Oriented training with Rhythmic Auditory Stimulation |
3 weeks, 5 days/week, 50 min /session
It is therapeutic approach derived on the idea of motor control which governs the movement of nervous system and also work under principle of neural plasticity. A task-oriented strategy or therapy focusses primarily on improving functional activities. It has been discovered that "the interaction between the task, the individual, and the environment in which it is carried out leads to movement.
the effects of auditory rhythm are seen in the motor system and at the brainstem level because of the audiomotor pathways that communicate through reticulospinal connections. Humans typically move in accordance with biological rhythms, and when external auditory stimulus that is rhythmically organised is given, movement is regulated in accordance with that rhythm |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Middle cerebral artery infarct
Hemiplegic patients
Post stroke from 2 months to 1 year
Voluntary control grading from grade 2-5
Brunnstorm stages of recovery from 3-6
Mini mental state of examination score more than 24
|
|
| ExclusionCriteria |
| Details |
Visual deficit
Auditory deficit
Cognitive impairment
Perceptual disorders
Contracture of upper limb
Dementia
Uncontrolled hypertension
NPRS 7-10(severe)
Shoulder subluxation /dislocation
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Standardized Nine hole peg test for assessing dexterity: |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fugl-Meyer Assessment for upper extremity
Stroke specific quality of life questionnaire |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/11/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Stroke is the most common cause of long-term disability. In about 70–80% of stroke patients, upper limb (UL) impairment is present. However, it is crucial to improve the use of the affected upper limb because having difficulty in performing daily activities is associated with reduced quality of life. [1] However, both task-oriented training and arm ability training with rhythmic auditory stimulation are believed to enhance the functional recovery of the upper limb by improving upper limb dexterity and quality of life. A randomized study is performed after appropriate ethical clearance and consent by the concerned authorities, as well as patients to conduct the study. A total of 50 participants were recruited for the study based on inclusion and exclusion criteria. All the participants were randomly divided into 2 groups, where Group A received task-oriented training with rhythmic auditory stimulation and Group B received arm ability training with rhythmic auditory stimulation. Both groups received treatment for up to 45 minutes, 2 sets with 2-3 minutes of rest, followed by every 15 minutes of continuous training and 5 days per week for up to 3 & 4 weeks. Individuals were assessed using the outcome measures, Fugl-Meyer Assessment Upper Extremity (FMA-UE), Stroke quality of life scale (SQOL) and Modified Standardized Nine -Hole peg test (mS-NHPT) before the treatment and after three & four weeks post-treatment |