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Neurological DisorderNCT02795507

Cross Education in Patients With Sensorimotor Impairment

A study testing Rehabit-Tec System and conventional exercises in people with Neurological Disorder, run by Nachum Soroker, MD at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Neurological Disorder
What is being tested?
Rehabit-Tec System and conventional exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIsrael
Study dates
Jul 2016to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Silvi Frenkel-Toledo contact

972545509413

silvi197@bezeqint.net

Nachum Soroker contact

nachums@clalit.org.il

Israel1 site, 1 recruiting
  • Loewenstain hospital

    Raanana

    Nachum Soroker, MD

    Silvi Frenkel-Toledo, PhD, 972545509413, silvi197@bezeqint.net

    Recruiting

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Rehabit-Tec System, conventional exercises
Keywords
cross education, visual feedback
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabit-Tec SystemDevice

    Device with visual and kinesthetic feedback

  • Rehabit-Tec SystemDevice

    Device without visual and kinesthetic feedback

  • conventional exercisesBehavioural

Study groups in NCT02795507
Study groupRoleWhat they receive
Device with feedback & exercisesExperimentalTraining 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.
Receives: Device: Rehabit-Tec System; Behavioral: conventional exercises
Device without feedback & exercisesActive comparatorTraining 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.
Receives: Device: Rehabit-Tec System; Behavioral: conventional exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fugl-Meyer Assessment

    Score of 66 point indicate normal motor functioning of upper limb

    Measured: 3 weeks

Secondary outcomes (2)
  1. Change in Box and blocks test

    Number of cubes transferred from one side of cube (chamber) to the other side of the cube within a minute

    Measured: 3 weeks

  2. Number of flexion movements of the fingers during half a minute

    will be assessed using motion-sensing gloves

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionMay 2019 (estimated)
  4. Study completionMay 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02795507
Sponsor's protocol ID
LOE161116CTIL
Status last verified
Aug 2017
First submitted
6 Jun 2016
Last updated
1 Sep 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Rehabit-Tec System and conventional exercises in people with Neurological Disorder, run by Nachum Soroker, MD at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Silvi Frenkel-Toledo (972545509413, silvi197@bezeqint.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fugl-Meyer Assessment (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.

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