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

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ClinicalTrials.gov Identifier: NCT03671876
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Selfit Medical

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE June 11, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03671876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Device: Intervention plus therapy
Task oriented exercise plan to improve mobility for stroke patients
Study Arms  ICMJE
  • 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.

    Intervention: Device: Intervention plus therapy
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
50
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03671876
Other Study ID Numbers  ICMJE TASMC-08-ID-052717-CTIL
MOH_2018-04-11_002309 ( Registry Identifier: Ministry of Health Israel )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Selfit Medical
Study Sponsor  ICMJE Selfit Medical
Collaborators  ICMJE Tel-Aviv Sourasky Medical Center
Investigators  ICMJE
Principal Investigator: Israel Dudkiewicz, Prof. Tel-Aviv Sourasky Medical Center
PRS Account Selfit Medical
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP