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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

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Intervention plus therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 31, 2019

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.




Primary Outcome Measures :
  1. Changes in patient's average speed [ Time Frame: 3 weeks ]
    Change from baseline in mobility skills - speed (m/sec)

  2. Changes in patient's average distance [ Time Frame: 3 weeks ]
    Change from baseline in mobility skills - distance (m)

  3. Changes in patient's number of steps [ Time Frame: 3 weeks ]
    Change from baseline in mobility skills - number of steps

  4. Changes in patient's steps height [ Time Frame: 3 weeks ]
    Change from baseline in mobility skills - steps height (avg. in cm)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671876


Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel-Aviv, Israel, 6291789
Sponsors and Collaborators
Selfit Medical
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Israel Dudkiewicz, Prof. Tel-Aviv Sourasky Medical Center

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Responsible Party: Selfit Medical
ClinicalTrials.gov Identifier: NCT03671876     History of Changes
Other Study ID Numbers: TASMC-08-ID-052717-CTIL
MOH_2018-04-11_002309 ( Registry Identifier: Ministry of Health Israel )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selfit Medical:
Stroke
Sub-acute
Mobility
Movement therapy
Exercise
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases