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CTRI Number  CTRI/2024/03/064490 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Prototype of an assistive device (modified single point cane)]  
Study Design  Single Arm Study 
Public Title of Study   Developing a prototype of a modified single point cane and checking its efficacy on stroke patients based on energy consumption, number of steps per minute and walking speed. 
Scientific Title of Study   Prototype development and testing of a modified single point cane based on energy expenditure, cadence and walking velocity for 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  Manisha Samal  
Designation  Student (Master of Prosthetics and Orthotics)) 
Affiliation  ISIC Institute of Rehabilitation Sciences  
Address  Department of Prosthetics and Orthotics (Basement), Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector C Vasant Kunj, IAA Colony, New Delhi
South West
DELHI
110070
India 
Phone  7978044863  
Fax    
Email  samalmanisha2029@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sakshi Saharawat 
Designation  Assistant Professor (P and O) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Department of Prosthetics and Orthotics (basement), Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences.
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector C Vasant Kunj, IAA Colony, New Delhi
South West
DELHI
110070
India 
Phone  8750494749  
Fax    
Email  isic.sakshi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sakshi Saharawat 
Designation  Assistant Professor (P and O) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  Department of Prosthetics and Orthotics (basement), Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences.
Indian Spinal Injuries Centre, Institute of Rehabilitation Sciences, Sector C Vasant Kunj, IAA Colony, New Delhi
South West
DELHI
110070
India 
Phone  8750494749  
Fax    
Email  isic.sakshi@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre, Prosthetics and orthotics department and Rehabilitation Department  
 
Primary Sponsor  
Name  Manisha Samal 
Address  indian spinal injuries center sec-c, vasant kunj, new delhi, opp vasant valley school. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Saharawat   Indian spinal injuries center  Department of Prosthetics and Orthotics (Basement) sec-c, vasant kunj, new delhi opp vasant valley school
New Delhi
DELHI 
8750494749

isic.sakshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified single point cane.   The prototype of the modified single point cane has addition of a recoiling spring, rubber covering at handle and microcellular rubber at the base.it aim to provide shock absorption. the duration of intervention is 30 minutes 
Comparator Agent  No comparator  As this is a single arm study, it does not include a comparator or control group. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  First cerebrovascular accident.
FAC 4 OR 5
MMSE 25 OR MORE 
 
ExclusionCriteria 
Details  Neurological co-morbidities other than stroke.
history of recurrent stroke.
Cardiovascular and musculoskeletal conditions that could influence gait or oxygen consumption 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Energy Expenditure   After 30 minutes of adaptation  
 
Secondary Outcome  
Outcome  TimePoints 
walking velocity
cadence  
After 30 minutes of adaptation 
 
Target Sample Size   Total Sample Size="19"
Sample Size from India="19" 
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)   29/03/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Cerebrovascular accident (CVA) causes severe disability, including motor weakness, sensory impairment, and coordination dysfunction. Stroke survivors achieved partial or total independence in activities of daily living. Impaired walking ability greatly contributes to functional disability after stroke. Hemiplegic gait is characterized by a marked reduction in velocity and alternations in other temporal and spatial parameters. Most stroke survivors regain their ability to walk but their speed, step length, and cadence remain significantly reduced. There are many types of walking aids used by patients after stroke, but all have different physiological costs of walking produced by these devices. Canes are prescribed widely as walking aids and their effect on restoring functional mobility and symmetric gait pattern is much concerned. Walking aids aim to improve safety walking ability and stability. Previous studies have shown that in hemiplegic patients with good balance, single-point cane is more effective in increasing gait endurance, cadence, velocity, and stability as compared to a quad cane and walker but the use of a single-point cane is associated with increased energy expenditure as compared to other canes. Previous studies also say that more researches are required on single point cane for hemiplegic subjects. Limited studies have been found about individuals with stroke using any modified single-point cane focusing on decreasing energy expenditure. So, the aim of the study is to develop a prototype of a modified single point cane and evaluate its efficacy based on energy expenditure, cadence, and walking velocity for individuals with stroke. The procedure will start with the development of the prototype of the modified single-point cane based on the requirements and then comparing its efficacy with the standard single-point cane based on energy expenditure, cadence and walking velocity. Proper resting time will be provided to the subjects. Prototype testing will be done on the patient under the supervision of the guide in the clinical set up. Place of research will be Indian Spinal Injury Center, Vasant Kunj, New Delhi. Risks and discomfort associated with the study is minimum to low. Sampling will be done using non-probability convenient sampling method. Subjects with first cerebrovascular accident and being able to walk with cane for 10m with FAC score of 4/5 will be recruited in the study according to the inclusion criteria. The required data of the subjects will be collected after taking their consent. Cane will be selected in a randomized order. The data will be collected both for standard and modified single point cane based on energy expenditure(PCI), cadence and walking velocity providing proper resting period to the patient. After the completion of collecting the data, the data will be analyzed using SPSS (statistical package for social science) software and statistical test will be done using Wilcoxon signed rank test or paired -t test based on the data’s normality.
 
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