| CTRI Number |
CTRI/2025/11/096888 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [occupational therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Combined Motor Imagery and Otago Exercise Program on Balance in Individuals with Stroke |
|
Scientific Title of Study
|
Effects of Combined Motor Imagery and Otago Exercises Versus Otago Exercises Alone on Balance in Individuals 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 |
Chandan singh |
| Designation |
Postgraduate student Master in occupational therapy (Neurology) |
| Affiliation |
Indian spinal injury centre institute of rehabilitation Sciences |
| Address |
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI
110070
India |
| Phone |
8595229962 |
| Fax |
|
| Email |
chandanotist1609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lipika malik |
| Designation |
Assistant professor |
| Affiliation |
indian spinal injury centre institute of rehabilitation Sciences |
| Address |
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lipika malik |
| Designation |
Assistant professor |
| Affiliation |
indian spinal injury centre institute of rehabilitation Sciences |
| Address |
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian spinal injury centre second floor ,opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
ISIC Institute of Rehabilitation Sciences |
| Address |
opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 lipika malik |
PMR department ground floor, Indian spinal injury center |
PMR department ISIC hospital Ground floor, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI |
9999931199
lipika.otist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INDIAN SPINAL INJURIES CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motor imagery with Otago exercise program
|
Each session lasted for 45 minutes and was conducted three days a week for four weeks. The session began with motor imagery training for about 15 minutes, which included 3 minutes of relaxation exercises, 10 minutes of guided motor imagery practice, and 2 minutes of refocusing. This was followed by 30 minutes of the Otago Exercise Program, consisting of standard strength and balance exercises. |
| Comparator Agent |
Otago exercises alone |
Each 45-minute session included 15 minutes of activity which include visualizing objects, scenes, and landscapes) followed by 30 minutes of the Otago Exercise Program with strengthening and balance exercises.45 min of each session 3 days a week for 4 weeks will be given. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 40 to 70 years, Individual diagnosed with stroke, Both male and female, Stroke duration more than 3 month, MOCA score greater than or equal to 26 points, Ability to imagine motor acts (completion of KVIQ10 greater than or equal to 25 points),Brunnstrom recovery stage 4 and 5 in paretic lower limb, Ability to ambulate at least 10m with or without support. |
|
| ExclusionCriteria |
| Details |
Any other diagnosed neurological and psychiatric disorder other than stroke,Any musculoskeletal condition including muscle contracture or limitation of joint motion in lower extrimity,Person with uncorrected visual ad hearing defects,Aphasia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance using Berg balance scale and for walking ability Time up and go test |
Pre test will be done before intervention after 4 week of intervention post test will be done and after 2 weeks follow up will be done |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
15/11/2025 |
| 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="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
|
This study titled “Effects of Combined Motor Imagery and Otago Exercises Versus Otago Exercises Alone on Balance in Individuals with Stroke” aims to evaluate whether integrating motor imagery with the Otago Exercise Program enhances balance recovery in stroke patients compared to the Otago program alone. Stroke often leads to impaired balance and increased fall risk, and while both motor imagery and Otago exercises are known to improve balance independently, limited evidence exists on their combined effect. The experimental study will include 28 participants divided into two groups—one performing Otago exercises only and the other combining Otago with motor imagery—over a 4-week, thrice-weekly intervention, each session duration of 45 minutes . Balance will be assessed using the Berg Balance Scale and Timed Up and Go Test before and after intervention. Data will be analyzed using appropriate statistical tests (t-test, Mann–Whitney U, ANOVA, or Friedman test) based on data distribution to determine the effectiveness of each approach. |