| CTRI Number |
CTRI/2024/07/071120 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Actuator for assisting in gait] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefits of using a battery operated orthosis to help in walking in post stroke patients |
|
Scientific Title of Study
|
Development of a newly wearable device to correct circumductory gait in stroke survivors of Odisha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Soumyashree |
| Designation |
Assistant professor |
| Affiliation |
Sri Sri University |
| Address |
Faculty of health & Wellness, 1st floor , Shruti Building, Sri Sri University.
Godi sahi, Ward no 3, Bidyadharpur, Cuttack- 754006
Cuttack
ORISSA
754006
India |
| Phone |
08328808305 |
| Fax |
|
| Email |
sonalimpt91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Soumyashree |
| Designation |
Assistant professor |
| Affiliation |
Sri Sri University |
| Address |
Room no-112, Faculty of Health & Wellness, 1st Floor, Shruti Building, Sri Sri University
Godi Sahi, Ward no 3, Bidyadharpur, Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
08328808305 |
| Fax |
|
| Email |
sonalimpt91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Soumyashree |
| Designation |
Assistant professor |
| Affiliation |
Sri Sri University |
| Address |
Faculty of Health & Wellness, 1st Floor Shruti Building, Sri Sri University
Godi Sahi,Ward no 3, Bidyadharpur, Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
08328808305 |
| Fax |
|
| Email |
sonalimpt91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Health & Wellness, 1st floor Shruti Building, Sri Sri University, Cuttack ,Odisha- 754006 |
|
|
Primary Sponsor
|
| Name |
Dr Tirthankar Ghosh |
| Address |
Dean, Faculty of Health & wellness, Shruti Building, 1st Floor, Sri Sri University,Bidyadharpur, Ward no 3, Godi sahi, Cuttack, Odisha. 754006 |
| 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 Sonali Soumyashree |
SRI SRI UNIVERSITY |
Room no 112, Faculty of Health & Wellness,Shruti Building, 1st floor.
Cuttack
ORISSA |
8328808305
sonalimpt91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research of Faculty of Health &Wellness,Sri Sri College of Ayurvedic Science and Research Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I611||Nontraumatic intracerebral hemorrhage in hemisphere, cortical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional gait training |
Gait training with verbal feedback and manual assistance will be given daily for 15 minutes for 1 week. |
| Intervention |
Gait training using the newly developed device |
The new device will be fitted in to the participant & gait variables (step length, stride length, gait velocity), muscle activity & endurance will be recorded. The participant will be asked to use the device daily & walk for 15 minutes & post data will be taken after 1 week while using the same device. Total duration of study: 1 week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- subacute stroke
- circumduction gait present
- Lower extremity power more than grade 3 |
|
| ExclusionCriteria |
| Details |
- acute stroke
- lower extremity weakness
- Gait abnormality due to any other condition other than stroke |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Step length & stride length measured in centimetres; gait velocity measured im m/s; a 6-minute walk test measured in metres; |
base line, 1 week, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EMG activity of hamstrings muscle |
baseline & after 1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 patients develop a circumductory gait which hampers their quality of life. This study aims to develop and apply an actuator based device to correct this circumductory gait in stroke patients |