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Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function

Primary Purpose

Stroke Patients

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hand tutor rehabilitation device
Arm tutor rehabilitation device
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment,
  • not affected cognitively (to be determined by the score on the mini mental exam greater than 23).
  • patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system.

Exclusion Criteria:

  • Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.

Sites / Locations

  • Sheba Medical Center rehabilitation facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

stroke patients - hand

stroke patient - arm

Arm Description

stroke patients with the ability to move their hand

stroke patients with the ability to move their arms

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment upper extremity part (FMA)
The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established
Arm and Hand Activity Inventory (CAHAI)
The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7
Motor Activity Log (MAL)
The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system
System Usability Scale (SUS)
This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool
Box& Block Test of Manual Dexterity
This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices

Secondary Outcome Measures

Full Information

First Posted
September 10, 2012
Last Updated
January 2, 2017
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01696864
Brief Title
Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
Official Title
Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of their caregivers. To achieve this goal the investigators will examine the effectiveness and feasibility of home rehabilitation system of upper limb, consisting of ergonomic accessories (hand and arm tutors). The quantitative indices will be based on the quantitative clinical measures that are used in regular evaluations of stroke patients and function and range of motion indices as received from the system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stroke patients - hand
Arm Type
Experimental
Arm Description
stroke patients with the ability to move their hand
Arm Title
stroke patient - arm
Arm Type
Experimental
Arm Description
stroke patients with the ability to move their arms
Intervention Type
Device
Intervention Name(s)
Hand tutor rehabilitation device
Intervention Description
A rehabilitation device for the hand
Intervention Type
Device
Intervention Name(s)
Arm tutor rehabilitation device
Intervention Description
A rehabilitation device for the arm
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment upper extremity part (FMA)
Description
The FMA assesses the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale, and the total score for the upper extremity ranges from 0-60 points where a higher score represents more active movements. An additional part assesses the coordination of the affected upper extremity and the score ranges between 0-6 where a higher score represents poorer coordination ability. This test is one of the most commonly used instruments in rehabilitation and its validity and reliability have been well established
Time Frame
10 minutes
Title
Arm and Hand Activity Inventory (CAHAI)
Description
The test assesses the functional ability of the affected arm and hand of people with stroke. The abbreviated version includes 7 functional activities (e.g. open a jar of coffee) that require bilateral use of the upper extremities as well various types of grip. The score range between1 and 7
Time Frame
10 minutes
Title
Motor Activity Log (MAL)
Description
The MAL consist of a semi structured interview for the patient to assess the use of the paretic arm and hand during daily activities. Two scores on a scale of 1 -5, are given for each activity;for the amount of use (AOU) and for the quality of movement (QOM). Usability of the system i.e. ease of use of the system
Time Frame
10 minutes
Title
System Usability Scale (SUS)
Description
This questionnaire includes 10 items rated on a 5 points scale, which provide a global view of subjective assessment of a system's usability. The item scores were calculated to give an overall score ranging from 10 to 100 points. The SUS has been shown to be a robust and reliable evaluation tool
Time Frame
10 minutes
Title
Box& Block Test of Manual Dexterity
Description
This is a valid and reliable test which is used to assess hand dexterity. In addition it is used to assess endurance of the upper extremity. The subject is asked to transfer cubes, above a partition, from one side of a box to the other for one minute with both hands. The score is the number of cubes that were transferred. In addition: Range of motion of fingers, wrist elbow and shoulder as measured by the devices
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment, not affected cognitively (to be determined by the score on the mini mental exam greater than 23). patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system. Exclusion Criteria: Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabi Zeilig, Dr.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center rehabilitation facility
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function

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