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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intervention plus therapy
Sponsored by
Selfit Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Sub-acute, Mobility, Movement therapy, Exercise

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention plus therapy

Therapy and no intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Changes in patient's average speed
Change from baseline in mobility skills - speed (m/sec)
Changes in patient's average distance
Change from baseline in mobility skills - distance (m)
Changes in patient's number of steps
Change from baseline in mobility skills - number of steps
Changes in patient's steps height
Change from baseline in mobility skills - steps height (avg. in cm)

Secondary Outcome Measures

Full Information

First Posted
September 6, 2018
Last Updated
February 16, 2021
Sponsor
Selfit Medical
Collaborators
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03671876
Brief Title
Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.
Acronym
Selfit
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Selfit Medical
Collaborators
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Sub-acute, Mobility, Movement therapy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention plus therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Therapy and no intervention
Arm Type
No Intervention
Arm Description
Control group: A population that suffered a stroke and is being treated in the hospital without any interventions with the Selfit system.
Intervention Type
Device
Intervention Name(s)
Intervention plus therapy
Intervention Description
Task oriented exercise plan to improve mobility for stroke patients
Primary Outcome Measure Information:
Title
Changes in patient's average speed
Description
Change from baseline in mobility skills - speed (m/sec)
Time Frame
3 weeks
Title
Changes in patient's average distance
Description
Change from baseline in mobility skills - distance (m)
Time Frame
3 weeks
Title
Changes in patient's number of steps
Description
Change from baseline in mobility skills - number of steps
Time Frame
3 weeks
Title
Changes in patient's steps height
Description
Change from baseline in mobility skills - steps height (avg. in cm)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Dudkiewicz, Prof.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6291789
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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