| CTRI Number |
CTRI/2026/03/105778 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The impact of rhythm-based auditory cues and cognitive task training on walking ability, balance and balance confidence in chronic stroke patients |
|
Scientific Title of Study
|
Effect of rhythmic auditory stimulation combined with cognitive task training on gait velocity, balance and balance confidence in chronic stroke patients- A quasi-experimental study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahnavi |
| Designation |
Pg Student |
| Affiliation |
DAV Institute of Physiotherapy and Rehabilitation |
| Address |
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9729660478 |
| Fax |
|
| Email |
jahnavigarg747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gulnaaz Kaur (PT) |
| Designation |
Assistant Professor |
| Affiliation |
DAV Institute of Physiotherapy and Rehabilitation |
| Address |
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9646707471 |
| Fax |
|
| Email |
gulnaazkaur03704@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jahnavi |
| Designation |
Pg Student |
| Affiliation |
DAV Institute of Physiotherapy and Rehabilitation |
| Address |
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9729660478 |
| Fax |
|
| Email |
jahnavigarg747@gmail.com |
|
|
Source of Monetary or Material Support
|
| DAV Institute of Physiotherapy and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Gulnaaz Kaur |
DAV Institute of Physiotherapy and Rehabilitation |
DAV Institute of Physiotherapy and Rehabilitation, Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB |
9646707471
gulnaazkaur03704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Warm up (5 minutes), exercises for muscle strengthening (5-7 minutes), balance exercises (10 minutes) and gait training (10 minutes). |
| Intervention |
Rhythmic auditory stimulation combined with cognitive task training |
Gait training with external rhythmic cues and structured dual task cognitive exercises for 30 minutes per session. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Both genders will be included between 40 to 80 years of age.
Subjects with chronic ischemic or hemorrhagic stroke.
Able to walk for at least 10 meters.
Those who could communicate and were able to follow instructions.
Subjects who are willing to participate in the study.
Mini Mental State Examination score more than 24.
Brunnstrom recovery stage 3 or 4 of lower extremity.
|
|
| ExclusionCriteria |
| Details |
Severe aphasia and cognitive decline.
Severe visual or hearing impairment.
Any other pre diagnosed neurological disorders such as multiple sclerosis, Parkinson disease.
Any pre diagnosed cardiovascular pathologies such as coronary heart disease.
Any orthopaedic diseases of lower limb like osteoarthritis.
Any type of malignancy.
Pregnant women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of rhythmic auditory stimulation combined with cognitive task training on gait velocity in patients with chronic stroke.
To evaluate the effect of rhythmic auditory stimulation combined with cognitive task training on balance in patients with chronic stroke.
To evaluate the effect of rhythmic auditory stimulation combined with cognitive task training on balance confidence in patients with chronic stroke.
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the risk of fall.
To improve the gait pattern.
To improve the quality of life.
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/05/2026 |
| 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="6"
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 total duration for study will be one and a half year. A minimum of 20 patients of chronic stroke (male and female) between the age of 40-80 years will be included in the study on the basis of inclusion and exclusion criteria using convenient sampling. The subjects will be divided into 2 groups (10 subjects in each group). Group A will be the experimental group and will receive Rhythmic Auditory Stimulation (RAS) combined with Cognitive Task Training. Group B will be the control group and will receive conventional gait and balance training. The treatment will be given for a duration of 6 weeks, 5 times per week for 30 minutes per session. The patients will be assessed using 10-meter walk test for gait velocity, berg balance scale for balance and activity-specific balance confidence scale for balance confidence. The data will be collected at first day and at third week and sixth week post-intervention. |