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Clinical Trials/CTRI/2024/03/064490
CTRI/2024/03/064490Not yet recruitingNot Applicable

Prototype development and testing of a modified single point cane based on energy expenditure, cadence and walking velocity for individuals with stroke.

Manisha Samal1 site in 1 country19 target enrollmentStarted: March 29, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
19
Locations
1
Primary Endpoint
Energy Expenditure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
45.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • First cerebrovascular accident.
  • FAC 4 OR 5 MMSE 25 OR MORE.

Exclusion Criteria

  • Neurological co-morbidities other than stroke.
  • history of recurrent stroke.
  • Cardiovascular and musculoskeletal conditions that could influence gait or oxygen consumption.

Outcomes

Primary Outcomes

Energy Expenditure

Time Frame: After 30 minutes of adaptation

Secondary Outcomes

  • walking velocity(cadence)

Investigators

Sponsor
Manisha Samal
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Manisha Samal

ISIC Institute of Rehabilitation Sciences

Study Sites (1)

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