| 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
|
|
|
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
|
|
|
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. |