NCT03671876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

September 6, 2018

Last Update Submit

February 16, 2021

Conditions

Stroke

Keywords

StrokeSub-acuteMobilityMovement therapyExercise

Outcome Measures

Primary Outcomes (4)

  • Changes in patient's average speed

    Change from baseline in mobility skills - speed (m/sec)

    3 weeks

  • Changes in patient's average distance

    Change from baseline in mobility skills - distance (m)

    3 weeks

  • Changes in patient's number of steps

    Change from baseline in mobility skills - number of steps

    3 weeks

  • Changes in patient's steps height

    Change from baseline in mobility skills - steps height (avg. in cm)

    3 weeks

Study Arms (2)

Intervention plus therapy

ACTIVE COMPARATOR

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

Therapy and no intervention

NO INTERVENTION

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

Interventions

Intervention plus therapyDEVICE

Task oriented exercise plan to improve mobility for stroke patients

Intervention plus therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- .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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6291789, Israel

Location

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

MethodsTherapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Israel Dudkiewicz, Prof.

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 14, 2018

Study Start

September 1, 2018

Primary Completion

January 10, 2019

Study Completion

January 31, 2019

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

IL(1)