Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System. (Selfit)

February 16, 2021 updated by: Selfit Medical

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel, 6291789
        • Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention plus therapy

Case group:

A population that suffered a stroke and treated to improve mobility with the Selfit system (25 patients) for twice a week, at least 30 minutes per session, for a period of 3 weeks.

Intervention with the Selfit system include a set of mobility task exercises.
Device: Intervention plus therapy
Task oriented exercise plan to improve mobility for stroke patients
No Intervention: Therapy and no intervention

Control group:

A population that suffered a stroke and is being treated in the hospital without any interventions with the Selfit system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient's average speed
Time Frame: 3 weeks
Change from baseline in mobility skills - speed (m/sec)
3 weeks
Changes in patient's average distance
Time Frame: 3 weeks
Change from baseline in mobility skills - distance (m)
3 weeks
Changes in patient's number of steps
Time Frame: 3 weeks
Change from baseline in mobility skills - number of steps
3 weeks
Changes in patient's steps height
Time Frame: 3 weeks
Change from baseline in mobility skills - steps height (avg. in cm)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selfit Medical

Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Israel Dudkiewicz, Prof., Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-08-ID-052717-CTIL
  • MOH_2018-04-11_002309 (Registry Identifier: Ministry of Health Israel)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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