Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants

September 21, 2023 updated by: Reuth Rehabilitation Hospital

A Prospective, Randomized, Open-label, Two-arms, Multi Center Feasibility Study to Evaluate the Safety and Efficacy of the PlaXtreme Device for Rehabilitation of the Hand in Post-stroke and Post TBI Participants

Background: Cerebrovascular accident [CVA or commonly known as stroke] and traumatic brain injury (TBI) are common causes of morbidity, and motor impairments. Many stroke and TBI patients encounter severe functional impairments of their arm and/or hand. Recent studies have indicated that robotic training can improve upper limb function by enabling repetitive, adaptive, and intensive training.

One type of robotic training is error enhancement during three-dimensional movements. The goal of this approach is to elicit better accuracy, stability, fluidity and range of motion during reaching.

Previous research indicated the potential of robotic training with error enhancement as a viable clinical intervention for individuals facing motor deficits.

Objectives: To evaluate the safety and efficacy of a new robotic system based on error enhancement and intended for rehabilitation of motor hand functions of post-stroke and TBI patients.

Methods: A randomized, multi-center study with an open-label design. The study sample will consist of 96 participants who will be randomized into 2 separate groups. The intervention group consisting of 48 patients will receive training with the new robotic system, while the control group consisting of additional 48 patients will receive only standard practice treatments (with no exposure to the new robotic system). The outcomes of safety (adverse events and treatment tolerability), and efficacy (motor function, speed, tone, and spasticity) will be assessed and compared between the two groups. The assessment of the outcomes will be conducted at four different time points: (1) prior to the initiation of the four-week intervention, (2) after 2 weeks of intervention, (3) at the conclusion of the intervention, and (4) at a three-month follow-up session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Stroke and traumatic brain injury (TBI) are leading causes for morbidity, hospitalization, and extended injury of motor system as well as movement learning. It has been proven that roughly 85% of stroke survivors suffer from weakness in their upper limbs, and around 40% of stroke survivors will suffer from severe handicap in their paretic arm, negatively affecting their independence and quality of life. Statically, about 50% - 70% of survivors will recover enough to enable daily use of their arm. These numbers indicate that although rehabilitation for stroke patients is evident, there remains a need for more effective methods.

Traditional rehabilitative methods are often time-consuming and labor-intensive. Only a few of these methods induce slightly improved arm function, and a full recovery is often not achieved. Recently, studies have indicated that robotic training has promise for improving functional abilities among stroke survivors by enabling repetitive, adaptive, intensive, and accurate control of task complexity during the rehabilitation period. One type of robotic training that is particularly promising is error enhancement; this utilizes the adaptive capabilities of the nervous system to improve fine motor function of the arm.

Study Objectives: To evaluate the change in the upper limb function amongst post-stroke and post-TBI patients undergoing error enhancement treatment compared to a control group in the following domains:

  1. Motor Function (Fugl-Meyer Assessment, Action Research Arm Test (ARAT), pinch and grip tests)
  2. Speed (Box and Blocks Assessment)
  3. Tone and Spasticity (Modified Ashworth Scale)

In addition, this study will examine the safety and patient tolerability of the device.

Methods Population: A total of 96 participants will be recruited within 3 medical centers participating in the study. The recruitment will take place between 14 days and up to 18 months after the onset of the stroke or brain injury.

Recruitment: Electronic medical records of newly hospitalized patients will be screened to identify potential study participants. All eligible patients will be offered to participate. After obtaining informed consent, an intake session will take place for screening and evaluation purposes, conducted by a qualified occupational therapist. Patients successfully passing the screening session will undergo randomization to one of the two study arms with 1:1 ratio in each of the medical centers conducting the study.

All the treatments will be conducted a separate occupational therapist who will be blinded to the patient allocation group. Patients in the intervention arm will undergo training sessions with the robotic device, 3 times a week for a period up to 4 weeks, while the patients in the control arm will receive standard rehabilitative care.

Patients in both groups will undergo additional evaluation sessions at the following time points: after 2 weeks of intervention, at the conclusion of the intervention (4 weeks), and at a three-month follow-up session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Ra'anana, Israel
        • Recruiting
        • Loewenstein Rehabilitation Center
        • Contact:
      • Tel Aviv, Israel, 6902732
        • Recruiting
        • Reuth Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemiparesis due to first stroke (ischemic or hemorrhagic) or TBI;
  • At least 14 days after the stroke or brain injury onset;
  • No more than 18 months after stroke or brain injury onset;
  • At least 4 weeks of remaining hospitalization in inpatient or outpatient rehabilitation ward;
  • Voluntary provided informed consent obtained prior to any screening procedures;
  • Cognitive status: Montreal Cognitive Assessment (MoCA test) score ≥ 22 or Mini Mental State Examination (MMSE) score > 24;
  • Upper extremity function: Score between 35 and 52 points out of 66 on the Fugl- Meyer (FG) test with sub scores of 21-32/36 for the upper arm and 14-20/24 for the wrist and hand.

Exclusion Criteria:

  • Complete paralysis of the affected side;
  • Uncontrolled epilepsy;
  • Upper-limb pain > 6 on 10-point Visual Analogue Scale (VAS);
  • Concomitant or past medical conditions that might interfere with the study (i.e. hemi spatial neglect, orthopedic problems, etc.);
  • Current participation in other interventional clinical study;
  • Fingers spasticity score on the affected hand > 3 on Modified Ashworth Scale (MAS);
  • Pregnant or nursing women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
All the participants allocated to this group will undergo rehabilitation according to each medical center's standard rehabilitation practice. In addition, the participants will receive 12 therapy sessions incorporating error enhancement (3 session a week, for a period of 4 weeks), lasting approximately 25-30 minutes each.
Device: PlaXtreme

A robotic device capable of applying motor error enhancement forces during upper limb practice in a virtual environment. The forces stimulate the body's instinctive adaptive response, which does not require the use of cognition to correct the patients hand movement.

The device consists of a controller and specifically designed games projected on a screen requiring 3D active reaching movements. During the treatment sessions, the device will be operated by a trained occupational therapist.
No Intervention: Control
All participants allocated to this study group will undergo rehabilitation according to each medical center's standard rehabilitation practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ARAT score
Time Frame: 4 months

The Action Research Arm Test (ARAT) is a reliable, valid and standardized assessment of post-stroke hemiparetic Upper Extremity functional limitations.

The instrument contains 19 items grouped into 4 subtests; grasp, grip, pinch, and gross motor.

Each item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) and then item ratings are summed and reported out of 57 points with higher score indicating greater Upper Extremity function.

In this study, the ARAT will be conducted only on the paretic hand.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Box and Block Test (BBT)
Time Frame: 4 months

The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test, extensively used among a wide range of populations, including patients who have suffered from a stroke.

During the assessment, the subject sits at a table in front of a box with two compartments. The first has 150 blocks, while the second is empty. The participant must move as many blocks as he or she can (one at a time) in 60 seconds. The final score is the number of moved blocks out of a possible score of 150.

During the assessment, the box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb. Additionally, a 15-second trial period is permitted at the beginning of each side.

In this study, the BBT will be conducted on both of the patient's hands.
4 months
Pinch test
Time Frame: 4 months

The Pinch test evaluates hand and upper extremity. The measurements are conducted using a pinch dynamometer by squeezing the pinch meter between the thumb and forefinger.

In this study, the Pinch test will be conducted on both of the patient's hands.
4 months
Fugl-Meyer Assessment
Time Frame: 4 months
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scale items are scored on the basis of ability to complete each item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. This FMA score for a paretic upper limb may range from 0 to 66, with a lower score indicating higher impairment. The FMA scores will be used in this study not only for evaluation, but also as an inclusion criterion, as described in the inclusion/exclusion criteria section.
4 months
Functional Ambulatory Category
Time Frame: 4 months

Functional Ambulation Categories (FAC) classify the patient's walking as dependent or non-dependent. This is a visual measurement of walking scored according to 6-point scale to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.

  • A score of 0 indicates that the patient is a non-functional ambulator (cannot walk);
  • A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3)
  • A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score)
4 months
Trunk control test
Time Frame: 4 months
The Trunk Control Test (TCT) is used to assess trunk movements in patients that have suffered from a neurological disorder (i.e stroke) The test consists of four tasks performed on a bed: rolling to a weak side, rolling to a strong side, balance in sitting position on the edge of the bed with the feet off the ground for at least 30 seconds and sitting up from a lying down position. Each task is graded with the following scores: 0 = for inability to perform the task, 12= if subject is able to perform the task but with help or in an abnormal style and 25=if subjects is able to perform the task normally. The total score ranges from 0 to 100 points, with higher score indicating better performance.
4 months
Modified Ashworth Scale
Time Frame: 4 months

The Modified Ashworth Scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. It is performed by extending the patient's limb from a position of maximal possible flexion to maximal possible extension. Afterwards, the patient is assessed while moving from extension to flexion.

In this study, the MAS will be conducted only on the paretic hand.
4 months
Visual Analogue Scale (VAS)
Time Frame: 4 months
The Visual Analogue Scale is a pain rating scale used to determine pain severity and intensity. A standard analog scale ranges (0) meaning no pain to (10) meaning the worst pain imaginable. A patient has to mark a point on the line that matches the amount of pain he or she are experiencing.
4 months
Grip test
Time Frame: 4 months
The grip test using dynamometer assesses the maximum grip force to evaluate the grip strengh of the hand.
4 months
Clinical Global Impression Scale (CGI)
Time Frame: 4 months
Clinical Global Impression Scale (CGI) severity is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The assessdment tool provided with a seven-point scale of severity of patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.)
4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device safety
Time Frame: 4 weeks
The incidence of adverse events including, severity and association to the device.
4 weeks
Treatment tolerability
Time Frame: 4 weeks
Percent of patients failing to complete the study due to device-related procedural event/s or reluctance of further use of the device.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reuth Rehabilitation Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loewenstein Hospital
BioXtreme

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rami Mansour, MD, Reuth Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0013-22-RRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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