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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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.
Nachum Soroker contact
Israel1 site, 1 recruiting
- Recruiting
Loewenstain hospital
Raanana
Nachum Soroker, MD
Silvi Frenkel-Toledo, PhD, 972545509413, silvi197@bezeqint.net
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.
- Conditions
- Neurological Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Device with feedback & exercises | Experimental | 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. Receives: Device: Rehabit-Tec System; Behavioral: conventional exercises |
| Device without feedback & exercises | Active comparator | 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. 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.
Change in Fugl-Meyer Assessment
Score of 66 point indicate normal motor functioning of upper limb
Measured: 3 weeks
Secondary outcomes (2)
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
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.
- First posted10 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nachum Soroker, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor-investigator, Nachum Soroker, MD, Loewenstein Hospital
- Investigators
- Nachum Soroker, Principal investigator, Loewenstein rehabilitation hospital, Raanana, ISRAEL
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Education in Patients With Sensorimotor Impairment
- ClinicalTrials.gov ID
- NCT02795507
- Acronym / sponsor ID
- LOE161116CTIL
- Conditions
- Neurological Disorder
- Keywords
- cross education, visual feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nachum Soroker, MDUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Jul 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device with feedback & exercises | Experimental | Device: Rehabit-Tec System, Behavioral: conventional exercisesTraining 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 without feedback & exercises | Active comparator | Device: Rehabit-Tec System, Behavioral: conventional exercisesTraining 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having unilateral motor and/or sensory impairment of the upper limb due to neurological disorder
- Able to provide informed consent
Key exclusion criteria (1 listed)
- For patients who will be asked to participate in the fMRI/DTI examination only: having pacemakers and metal body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabit-Tec SystemDevice with visual and kinesthetic feedback | Device | Device with feedback & exercises |
| Rehabit-Tec SystemDevice without visual and kinesthetic feedback | Device | Device without feedback & exercises |
| conventional exercises | Behavioural | Device with feedback & exercises, Device without feedback & exercises |
Primary outcome
Change in Fugl-Meyer Assessment
Time frame: 3 weeks
Score of 66 point indicate normal motor functioning of upper limb
2 secondary outcomes
Change in Box and blocks test
Time frame: 3 weeks
Number of flexion movements of the fingers during half a minute
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Soroker contact
Nachum Soroker principal investigator
Loewenstein rehabilitation hospital, Raanana, ISRAEL
1 site in 1 country: see every site and its status.
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.