| CTRI Number |
CTRI/2025/12/099223 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of multidirectional reach and sit-to-stand exercises with rhythmic sound cues on trunk control and standing postural control in patient with stroke |
|
Scientific Title of Study
|
Effect of multidirectional reach and sit to stand training with rhythmic auditory stimulation on trunk control and standing postural control in Patient with 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 |
Anjana Dinesh |
| Designation |
Post Graduate student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
6th floor, department of physiotherapy, Yenepoya Physiotherapy College university road, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8431742551 |
| Fax |
|
| Email |
anjanadineshkk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ms Anjana S |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
6th floor, department of physiotherapy, Yenepoya Physiotherapy College university road, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Ms Anjana S |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
6th floor, department of physiotherapy, Yenepoya Physiotherapy College university road, Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
6363924912 |
| Fax |
|
| Email |
anjanas@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| 6th floor, department of physiotherapy, Yenepoya Physiotherapy College university road, Deralakatte, Mangaluru |
|
|
Primary Sponsor
|
| Name |
Anjana Dinesh |
| Address |
Yenepoya Physiotherapy College University Road, Deralakatte, Mangaluru, 575018, Karnataka ,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 |
| Dr Anjana Dinesh PT |
Yenepoya Ayurveda medical college |
4th floor,Yenepoya Ayush campus naringana, Deralakatte mangalore ,Karnataka 575018 Dakshina Kannada KARNATAKA |
8431742551
anjanadineshkk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee-3 |
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 |
| Intervention |
Multi Directional reach |
Multidirectional reaching was performed in forward, diagonal (right and left), and backward directions. Participants were instructed to reach toward a target placed at shoulder height, while maintaining an upright trunk posture.
• In forward reach, the patient reached forward on Beat 1 and returned to the starting position on Beat 2.
• In diagonal reach, the arm moved diagonally across the body toward the target, with Beat 1 for reach, Beat 2 for hold, and Beat 3 for return.
• In backward reach, the arm was extended backward while maintaining postural stability, synchronized with rhythmic cues.
Each reach direction was performed for 15 repetitions, with approximately 5 minutes allotted per direction. |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Rhythmic auditory stimulation |
While doing Multi directional reach Cueing: Move in sync with the beat (extend on 1st beat, return on 2nd beat)
While doing sit to stand training
Cueing: “Lean forward on beat 1, hold on beat 2, push up on beat
Cueing: Follow a 1-2-3-4 beat pattern: Beat 1: Lean forward Beat 2: Lift hips Beat 3: Extend knees Beat 4: Stand fully upright
|
| Intervention |
Sit to stand Training |
Sit-to-stand training was performed using rhythmic auditory cues to facilitate movement sequencing and postural control.
1. STS with Forward Weight Shift and Hold
The participant was instructed to lean forward, rise to standing, and maintain upright posture for 5 seconds.
• Beat 1: Forward lean
• Beat 2: Lift hips
• Beat 3: Knee extension
• Beats 4–8: Hold standing position
2. Controlled STS with Arm Support
The participant used arm support to assist with a smooth and controlled sit-to-stand movement.
• Beat 1: Lean forward
• Beat 2: Rise
• Beat 3: Sit down
3. Repetitive STS with Rhythmic Cueing
Continuous sit-to-stand repetitions were performed in synchrony with the auditory beats to enhance coordination and balance.
Each STS exercise was performed for 10 repetitions, with 5 minutes allocated for each activity. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Acute Stroke 1–7 days ,Subacute Stroke : Early 1 week-3 months Post stroke 3-6 months, Ischemic or hemorrhagic stroke, Trunk impairment scale score minimum 7,MMSE greater than 24,Brunnstrom Recovery Stage- 4 to 6 |
|
| ExclusionCriteria |
| Details |
Trunk instability where the patient cannot sit
Subjects with any musculoskeletal disorders such as recent fractures/dislocations, congenital/acquired disorders/deformities,
acute/chronic arthritis any Cardio-vascular disorders Other
neurological problems such as preexisting neurological disorders
and progressive diseases
(like Dementia, Alzheimer’s disease, Parkinsonism, Brain tumours,
Cerebral palsy)
Subjects with any visual or auditory problems
(Blindness, colour vision, diplopia, total or partial blindness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Trunk impairment scale
2.Postural assessment scale of stroke |
Pre test before intervention
Post test after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MMSE |
Pre assessment before intervention |
|
|
Target Sample Size
|
Total Sample Size="23" Sample Size from India="23"
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)
|
26/12/2025 |
| 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 is a Single group Pre-Post Experimental Study design that will be focusing on evaluating the effect of multi directional reach and sit to stand training combining it With rhythmic auditory stimulation on trunk control and standing postural control. Participants will be selected from yenepoya ayurveda medical college using purposive sampling technique. The mini mental state scale examination in screening time. Postural Assessment Scale for stroke (PASS) and Trunk impairment scale (TIS)will be assessed before giving the intervention and 4 weeks post treatment . The experiment involves the Sit to stand training and Multidirectional Reach with rhythmic auditory stimulation . Measurements will be taken solely by the Principal Investigator (PI). Only authorized study personnel will be present during the measurement. This study will adhere to ethical guidelines, and participants will provide informed consent before participating in the research. Confidentiality and privacy of participant information will be strictly maintained. This study aims to provide valuable insights into the effect of multi directional reach and sit to stand training with rhythmic auditory stimulation on trunk control and standing postural control among stroke population |