Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.
NCT ID: NCT03671876
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-09-01
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 plus therapy
Task oriented exercise plan to improve mobility for stroke patients
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.
No interventions assigned to this group
Interventions
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Intervention plus therapy
Task oriented exercise plan to improve mobility for stroke patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
.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.
18 Years
85 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Selfit Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Israel Dudkiewicz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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MOH_2018-04-11_002309
Identifier Type: REGISTRY
Identifier Source: secondary_id
TASMC-08-ID-052717-CTIL
Identifier Type: -
Identifier Source: org_study_id
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