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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01696864
First received: September 10, 2012
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Stroke Patients
Device: Hand tutor rehabilitation device
Device: Arm tutor rehabilitation device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Fugl-Meyer Assessment upper extremity part (FMA) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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 established9

  • Chedoke Arm and Hand Activity Inventory (CAHAI) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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

  • The Motor Activity Log - MAL [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stroke patients - hand
stroke patients with the ability to move their hand
Device: Hand tutor rehabilitation device
A rehabilitation device for the hand
Other Name: Model : HNDT, MediTouch LTD
Experimental: stroke patient - arm
stroke patients with the ability to move their arms
Device: Arm tutor rehabilitation device
A rehabilitation device for the arm
Other Name: Model: HMAT, MediTouch LTD.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696864

Contacts
Contact: Meir Plotnik, PhD 0526668506 meir.plotnik@sheba.health.gov.il

Locations
Israel
Sheba Medical Center rehabilitation facility Not yet recruiting
Ramat Gan, Israel
Contact: Meir Potnik, PhD    972-52-6668506    meir.plotnik@sheba.health.gov.il   
Sub-Investigator: Meir Plotnik, PhD         
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01696864     History of Changes
Other Study ID Numbers: SHEBA-12-9471-GZ-CTIL
Study First Received: September 10, 2012
Last Updated: September 27, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 23, 2014