Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cross Education in Patients With Sensorimotor Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795507
Recruitment Status : Unknown
Verified August 2017 by Nachum Soroker, MD, Loewenstein Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2016
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Nachum Soroker, MD, Loewenstein Hospital

Brief Summary:
The purpose of this study is to investigate the effects of training of the non-involved upper limb on the motor ability of the hemiparetic upper limb in patients with unilateral sensorimotor motor impairments. The secondary aims are to investigate the relation between lesion characteristics and responsiveness to the treatment, and to study which brain structures are activated during a task trained in the treatment.

Condition or disease Intervention/treatment Phase
Neurological Disorder Device: Rehabit-Tec System Behavioral: conventional exercises Not Applicable

Detailed Description:

40 post-stroke subjects will be recruited from neurological rehabilitation department at Loewenstein Hospital Rehabilitation Center, Raanana, Israel. Hospitalized patients, discharged patients from this department and patients that visit the clinic at this department will be recruited. The patients will be randomly assigned to one of two groups: 1) Experimental group. 2) Control group. The 3 weeks intervention (15 sessions) in each group will include daily 30 minutes of structured training followed by 30 minutes of standard physical therapy exercises of the upper limbs (conventional sensorimotor active and passive exercises of the upper limb). During the structured training in the experimental group, patient's hand will be positioned in a specialized motion control apparatus (Rehabit-Tec System). This device consists of a forearm and wrist rest, and the fingers of each hand are individually strapped to the device with palms facing down. The finger is connected to a piston that moves a plunger on a potentiometer according to the degree of flexion. A control module reads the location of every potentiometer on each finger of the 'moving' hand and powers motors that push/pull the corresponding other hand finger to equalize the potentiometer's position. Each finger channel is independent and acts as a stand-alone control circuit. The device restricts voluntary movement of the 'other' hand fingers since only 'moving' hand finger movement activates the motors. Thus when the hands are strapped to the device, and the device is turned on, voluntary hand finger movement results in passive yoking of the corresponding 'other' hand fingers. The patient can't see his real hands and the device. Visual feedback of virtual hands are provided through a VR headset used for 3D gaming. The patient will wear motion-sensing gloves (5DT Data Glove Ultra) that allow online monitoring of individual finger flexure in each hand. The training setup contains a head-mounted specialized 3D camera (PLAYSTATION Eye digital camera device) to provide online visual feedback of the real environment. These devices allow detection of the patient's real hand movements and translate them by customized software to the virtual hand movements presented on the screen. The virtual hands are embedded in a specific location in space and are presented only when the patient look down towards his real hand. In this group, the patients will move their non-involved hand, and will receive a visual feedback of a moving virtual hand in the non-involved side. A passive movement (providing kinesthetic feedback) of the non-involved hand will occur simultaneously by the device. For example: in a left hemiparetic patient, a movement of the right hand will result in observation of the left virtual hand and a passive movement of the left hand. The structured pre-training of the control group will be similar except that the patient will not receive a visual and kinesthetic feedback (passive movement) of the hemiparetic hand. The subjects will be asked to move their non-involved fingers as accurately and fast as they can.

Before and after each intervention the following tests will be used: Fugl-Meyer Assessment and box and blocks test as motor clinical assessment tests of the upper limb, and the ability to move the fingers (using the aforementioned gloves, For example: amount of flexion). Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics). Only before the intervention, sensory ability will be characterized using: Fugl-Meyer assessment of sensorimotor function (Sensory section) and Semmes-Weinstein filaments.

In Cases with specific theoretical interest, the subjects will be offered to be examined also in a fMRI/DTI using Magnetic Resonance Imaging (MRI) System - Siemens Prisma 3T scanner. The task during the imaging will be as during the structured pre-training.

Differences between groups will be done using t-tests or Mann-Whitney, depending on distribution of normality with corrections for multiple comparisons. Correlations or voxel-based lesion symptom mapping (VLSM) analyses will be conducted to investigate the relation between lesion extent and location and responsiveness to the treatments.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cross Education in Patients With Sensorimotor Impairment
Study Start Date : July 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device with feedback & exercises

Training using Rehabit-Tec System - patient's hand will be positioned in this specialized motion control apparatus which allows movement of the non involved hand while receiving visual feedback of a virtual hand in the paretic side and a passive movement of the paretic hand + followed by 30 minutes of exercises (conventional sensorimotor active and passive exercises of the upper limb).

5 days per week for 3 weeks, 1 hour per day.

Device: Rehabit-Tec System
Device with visual and kinesthetic feedback

Behavioral: conventional exercises
Active Comparator: Device without feedback & exercises

Training using Rehabit-Tec System - patient's hand will be positioned in a specialized motion control apparatus which allows movement of the non involved hand but without receiving visual feedback of a virtual hand in the paretic side and a passive movement of the paretic hand + followed by 30 minutes of exercises (conventional sensorimotor active and passive exercises of the upper limb).

5 days per week for 3 weeks, 1 hour per day.

Device: Rehabit-Tec System
Device without visual and kinesthetic feedback

Behavioral: conventional exercises



Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment [ Time Frame: 3 weeks ]
    Score of 66 point indicate normal motor functioning of upper limb


Secondary Outcome Measures :
  1. Change in Box and blocks test [ Time Frame: 3 weeks ]
    Number of cubes transferred from one side of cube (chamber) to the other side of the cube within a minute

  2. Number of flexion movements of the fingers during half a minute [ Time Frame: 3 weeks ]
    will be assessed using motion-sensing gloves



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having unilateral motor and/or sensory impairment of the upper limb due to neurological disorder
  • Able to provide informed consent

Exclusion Criteria:

  • For patients who will be asked to participate in the fMRI/DTI examination only: having pacemakers and metal body

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795507


Contacts
Layout table for location contacts
Contact: Silvi Frenkel-Toledo 972545509413 silvi197@bezeqint.net
Contact: Nachum Soroker nachums@clalit.org.il

Locations
Layout table for location information
Israel
Loewenstain hospital Recruiting
Raanana, Israel
Contact: Nachum Soroker, MD         
Contact: Silvi Frenkel-Toledo, PhD    972545509413    silvi197@bezeqint.net   
Sponsors and Collaborators
Nachum Soroker, MD
Tel Aviv University
Investigators
Layout table for investigator information
Principal Investigator: Nachum Soroker Loewenstein rehabilitation hospital, Raanana, ISRAEL
Layout table for additonal information
Responsible Party: Nachum Soroker, MD, head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02795507    
Other Study ID Numbers: LOE161116CTIL
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Nachum Soroker, MD, Loewenstein Hospital:
cross education
visual feedback
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases