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Clinical Trials/NCT03671876
NCT03671876
Completed
Not Applicable

Improving the Mobility of Patients After a Stroke (at a Sub-acute Stage) With the Help of the Selfit System - Testing the System's Feasibility, From the Point of View of the Therapist and the Patient.

Selfit Medical1 site in 1 country30 target enrollmentSeptember 1, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Selfit Medical
Enrollment
30
Locations
1
Primary Endpoint
Changes in patient's average speed
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Stroke is a leading cause of mobility disability for adults. Selfit is an advanced practice system that enables a wide range of exercises to improve patient mobility in the sub-acute stage after a stroke. The system collects, measures and analyzes the patient's activity in practice.

Detailed Description

Objectives of the study: An evaluation of the improvement of mobility after a stroke using the Selfit system. Type of study: Case Control Study. Study population: 30 patients, after stroke (men and women aged 18-85). Criteria for Inclusion: Stroke patients who are capable to walk with a little help or no help at all, with or without any assitive device, for a distance of 10 meters. Intervention: Random distribution of the study participants into two groups - Case: stroke patients (15 patients) - evaluation of patients using Selfit for 2 sessions per week, for a period of at least 30 minutes per session, during 3 weeks. Control: Stroke patients (15 patients) - continuing with current therapy with no use of the Selfit system. Measurement tools and outcome measures: Duration of each treatment session, the duration of the actual treatment, the number of technical failures in the system during the exercise and the duration of each session will be recorded. At the end of the intervention, questionnaires describing the experience of using the system will be completed with a rating of the degree of satisfaction, convenience and simplicity of using the Selfit system. The following tests will be carried out : 10 meter walk test, Timed up and go test, Dynamic Gait Index (DGI). Analysis of the data: For each patient's treatment, a personal activity profile will be established that includes the timing and speed of walking, the number of steps, the length and width of each step, the elevation of the leg at each step and the accuracy of the patient's performance. Statistical analysis will examine the various levels of activity throughout the intervention period for each patient and for the entire study population before and after the intervention. At the same time, the correlation between the level of activity in the treatment and the scores on the neurological tests will be examined. The data will be presented descriptively for the therapist and patient. For statistical analysis, the SPPS version 21 (IBM) will be used.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
January 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Selfit Medical
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Stroke .Must walk with little or no help at all, with or without an assistive device, for a distance of at least 10 meters.

Exclusion Criteria

  • .Patients suffering from significant lower back pain and / or previous orthopedic impairment and / or cognitive impairment (grade 18 and below according to the MOCA test).
  • .Patients who are unable to move with little or no help at all, with or without an assistive device, for a distance of 10 meters.

Outcomes

Primary Outcomes

Changes in patient's average speed

Time Frame: 3 weeks

Change from baseline in mobility skills - speed (m/sec)

Changes in patient's average distance

Time Frame: 3 weeks

Change from baseline in mobility skills - distance (m)

Changes in patient's number of steps

Time Frame: 3 weeks

Change from baseline in mobility skills - number of steps

Changes in patient's steps height

Time Frame: 3 weeks

Change from baseline in mobility skills - steps height (avg. in cm)

Study Sites (1)

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