Clinical trial NCT03671876: Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Sub-acute
Mobility
Movement therapy
Exercise
Lead sponsor: Selfit Medical
Sponsor class: INDUSTRY
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2018-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in patient's average speed
timeFrame: 3 weeks
measure: Changes in patient's average distance
timeFrame: 3 weeks
measure: Changes in patient's number of steps
timeFrame: 3 weeks
measure: Changes in patient's steps height
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Israel Dudkiewicz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: