CVA (Cerebrovascular Accident)NCT05174676
Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients
A study testing Dextreme in people with CVA (Cerebrovascular Accident) and Paresis, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial summary
Background: Stroke is a common cause of morbidity, including paresis, and stroke survivors often have reduced function in their paretic arm. Many do not regain full recovery of their arm function, which negatively impacts their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident), Paresis
- What is being tested?
- Dextreme
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2021to Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hebrew speaker.
- First stroke (ischemic or hemorrhagic).
- Weakness on one side of the body (left or right).
- At least 21 days have passed since the stroke event.
- At least 21 days left for inpatient rehabilitative care.
- Have partial mobility in the elbow and shoulder and the ability to open and close the hand.
- A minimum score of 10 (out of the 66) on the Fugl-Meyer Assessment for the upper limb.
- Cognitive status: Mini-Mental State Examination [MMSE] = 23 or higher; or MoCA test = 26 or higher.
Who cannot join
- Complete paralysis of the affected side.
- Comorbid central nervous system diseases that may affect brain plasticity (MS, ALS).
- Sensory Aphasia (as per the medical diagnosis).
- One-side neglect.
- Apraxia.
- Pregnancy or breastfeeding.
- Strong pain in the shoulder (VAS>6) that may prevent the ability to execute the tasks
- A severe orthopedic problem in the upper limb that prevents the ability to execute tasks on the robotic system.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Reuth Rehabilitation Hospital
Tel Aviv, 6902732
Beth Zalcman, MPH, +972732701610, beth.zalcman@reuth.org.il
About this study
Official title: Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients: A Randomized Controlled Trial
Background: Stroke is a common cause of morbidity, including paresis, and stroke survivors often have reduced function in their paretic arm. Many do not regain full recovery of their arm function, which negatively impacts their quality of life. Recent studies have indicated that robotic training may improve upper limb function abilities among stroke survivors, by enabling repetitive, adaptive, and intensive training and more accurate control of task complexity. Robotic training in addition to standard rehabilitative care has shown promise for improving functional skills among stroke survivors. One type of robotic training is error enhancement, whereby an error made by the patient is exaggerated, increasing the signal to noise ratio which causes errors to be more noticeable. This, in turn, enhances movement correction. Previous studies have found that error enhancement has promise as a clinical treatment for patients with motor deficits.
Objectives: This study aims to evaluate the effect of a robotic device (DeXtreme) on the functional capabilities of the paretic arm of stroke survivors. This device aims to improve arm function by utilizing error enhancement techniques.
Methods: A double-blind randomized placebo-controlled study comparing treatment outcomes between two groups to assess the effect of error enhancement robotic training on functional use of the arm and hand in patients after stroke. Forty stroke patients will undergo 6 sessions of 25 minutes each with the Dextreme device. One group will receive training with error enhancement forces applied, while the control group will receive similar training without error enhancement. Outcomes (motor function, speed, tone, and spasticity) will be assessed twice prior to and following the treatment sessions,
Read the detailed description
Background: At least 85% of stroke survivors suffer from weakness in their upper limbs. Around 40% of stroke survivors will suffer from severe handicap in their paretic arm, negatively affecting their independence and quality of life. Only 30% - 70% of survivors will recover enough function to enable daily use of the arm. These numbers clearly indicate that despite significant advances in the ability to rehabilitate stroke patients, there is still a need for more effective methods.
Traditional rehabilitative methods to improve arm function after stroke are often time-consuming and labor-intensive. Only few of these methods induce slightly improved arm function, and full recovery of arm function is often not achieved. Recently, studies have indicated that robotic training has promise for improving functional abilities among stroke survivors, by enabling repetitive, adaptive, and intensive training and more accurate control of task complexity. One type of robotic training that is particularly promising is error enhancement, which utilizes the adaptive capabilities of the nervous system to improve motor function.
Study Objectives: To examine the change in the upper limb function among stroke patients undergoing error enhancement treatment compared to a control group in the following domains:
- Motor Function (Motor Assessment Scale-MAS, Fugl-Meyer Assessment)
- Speed (Box and Blocks Assessment)
- Tone and Spasticity (Modified Ashworth Scale)
Methods Participants: 40 stroke patients with hemiparesis recruited 21-60 days following the Cerebrovascular accident event.
Recruitment: Electronic medical records of newly hospitalized patients will be screened to identify potential study participants. Participation will be offered to each patient who meets the study inclusion criteria. After obtaining informed consent, an intake session will take place for both participant screening and evaluation, conducted by a qualified occupational therapist. Patients who successfully pass the intake screening session will undergo randomization to one of the two study arms.
Another occupational therapist will be conducting the treatment sessions. Patients in the intervention arm will undergo training sessions on the Dextreme robot device, while the error enhancement mechanism is switched on, while the patients in the control arm will undergo similar sessions with the mechanism switched off. A second patient assessment will be conducted within 96 hours following the last treatment session by an allocation-blinded occupational therapist.
- Conditions
- CVA (Cerebrovascular Accident), Paresis
- Being tested
- Dextreme
- Keywords
- Brain plasticity, Upper limb function, Robotic rehabilitation, Error augmentation or enhancement
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextremeDevice
A unique 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 movement.
The setting of stroke patients in a simulated environment enhances patient motivation and participation. The completion of "games" (tasks) is a great indicator for the patients that they are progressing in the treatment and are on their way to recovery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participant will receive 6 therapy sessions of approximately 25 minutes each WITH the application of error enhancement. Receives: Device: Dextreme |
| Control | Sham comparator | The participant will receive 6 therapy sessions of approximately 25 minutes each WITHOUT the application of error enhancement. Receives: Device: Dextreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment #1
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. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. This study will utilize the Fugl-Meyer Assessment only for the paretic upper limb. The assessment scores will range from 0 to 66, with a lower score indicating higher impairment. A minimum score of 10 will be set as an inclusion criterion.
Measured: 1 session up to 96 hours prior to first treatment session
Fugl-Meyer Assessment #2
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. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. This study will utilize the Fugl-Meyer Assessment only for the paretic upper limb. The assessment scores will range from 0 to 66, with a lower score indicating higher impairment. A minimum score of 10 will be set as an inclusion criterion.
Measured: 1 session up to 96 hours after last (6th) treatment session
Motor Assessment Scale (MAS) #1
The Motor Assessment Scale (MAS) is a performance-based scale used to assess everyday motor function in patients with stroke. It is a validated tool comprised of 18 tasks for the upper limbs. Each task is given a score of 0 (unable to perform) to 1 (able to perform), and the overall score ranges from 0 to 18. This assessment will be applied to both upper limbs.
Measured: 1 session up to 96 hours prior to first treatment session
Motor Assessment Scale (MAS) #2
The Motor Assessment Scale (MAS) is a performance-based scale used to assess everyday motor function in patients with stroke. It is a validated tool comprised of 18 tasks for the upper limbs. Each task is given a score of 0 (unable to perform) to 1 (able to perform), and the overall score ranges from 0 to 18. This assessment will be applied to both upper limbs.
Measured: 1 session up to 96 hours after last (6th) treatment session
Box and Block Test (BBT) #1
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including patients with stroke.
During the assessment, the subject sits at a table in front of a box with two parts. The first part has 150 blocks, while the second part is empty. The participant must move as many blocks as he can (one at a time) in 60 seconds. The final score is the number of blocks he was able to move (out of a possible score of 150).
Measured: 1 session up to 96 hours prior to first treatment session
Box and Block Test (BBT) #2
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including patients with stroke.
During the assessment, the subject sits at a table in front of a box with two parts. The first part has 150 blocks, while the second part is empty. The participant must move as many blocks as he can (one at a time) in 60 seconds. The final score is the number of blocks he was able to move (out of a possible score of 150).
Measured: 1 session up to 96 hours after last (6th) treatment session
Modified Ashworth Scale #1
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.
Measured: 1 session up to 96 hours prior to first treatment session
Modified Ashworth Scale #2
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.
Measured: 1 session up to 96 hours after last (6th) treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Dec 2021
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA (Cerebrovascular Accident)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami Mansour, MD, Principal investigator, Reuth Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174676
- Sponsor's protocol ID
- 0012-21-RRH
- Status last verified
- Jan 2022
- First submitted
- 29 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05174676
- Acronym / sponsor ID
- 0012-21-RRH
- Conditions
- CVA (Cerebrovascular Accident), Paresis
- Keywords
- Brain plasticity, Upper limb function, Robotic rehabilitation, Error augmentation or enhancement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Jan 2022 (actual)
- 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.
Background: Stroke is a common cause of morbidity, including paresis, and stroke survivors often have reduced function in their paretic arm. Many do not regain full recovery of their arm function, which negatively impacts their quality of life. Recent studies have indicated that robotic training may improve upper limb function abilities among stroke survivors, by enabling repetitive, adaptive, and intensive training and more accurate control of task complexity. Robotic training in addition to standard rehabilitative care has shown promise for improving functional skills among stroke survivors. One type of robotic training is error enhancement, whereby an error made by the patient is exaggerated, increasing the signal to noise ratio which causes errors to be more noticeable. This, in turn, enhances movement correction. Previous studies have found that error enhancement has promise as a clinical treatment for patients with motor deficits.
Objectives: This study aims to evaluate the effect of a robotic device (DeXtreme) on the functional capabilities of the paretic arm of stroke survivors. This device aims to improve arm function by utilizing error enhancement techniques.
Methods: A double-blind randomized placebo-controlled study comparing treatment outcomes between two groups to assess the effect of error enhancement robotic training on functional use of the arm and hand in patients after stroke. Forty stroke patients will undergo 6 sessions of 25 minutes each with the Dextreme device. One group will receive training with error enhancement forces applied, while the control group will receive similar training without error enhancement. Outcomes (motor function, speed, tone, and spasticity) will be assessed twice prior to and following the treatment sessions,
Detailed description
Background: At least 85% of stroke survivors suffer from weakness in their upper limbs. Around 40% of stroke survivors will suffer from severe handicap in their paretic arm, negatively affecting their independence and quality of life. Only 30% - 70% of survivors will recover enough function to enable daily use of the arm. These numbers clearly indicate that despite significant advances in the ability to rehabilitate stroke patients, there is still a need for more effective methods.
Traditional rehabilitative methods to improve arm function after stroke are often time-consuming and labor-intensive. Only few of these methods induce slightly improved arm function, and full recovery of arm function is often not achieved. Recently, studies have indicated that robotic training has promise for improving functional abilities among stroke survivors, by enabling repetitive, adaptive, and intensive training and more accurate control of task complexity. One type of robotic training that is particularly promising is error enhancement, which utilizes the adaptive capabilities of the nervous system to improve motor function.
Study Objectives: To examine the change in the upper limb function among stroke patients undergoing error enhancement treatment compared to a control group in the following domains:
- Motor Function (Motor Assessment Scale-MAS, Fugl-Meyer Assessment)
- Speed (Box and Blocks Assessment)
- Tone and Spasticity (Modified Ashworth Scale)
Methods Participants: 40 stroke patients with hemiparesis recruited 21-60 days following the Cerebrovascular accident event.
Recruitment: Electronic medical records of newly hospitalized patients will be screened to identify potential study participants. Participation will be offered to each patient who meets the study inclusion criteria. After obtaining informed consent, an intake session will take place for both participant screening and evaluation, conducted by a qualified occupational therapist. Patients who successfully pass the intake screening session will undergo randomization to one of the two study arms.
Another occupational therapist will be conducting the treatment sessions. Patients in the intervention arm will undergo training sessions on the Dextreme robot device, while the error enhancement mechanism is switched on, while the patients in the control arm will undergo similar sessions with the mechanism switched off. A second patient assessment will be conducted within 96 hours following the last treatment session by an allocation-blinded occupational therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: DextremeThe participant will receive 6 therapy sessions of approximately 25 minutes each WITH the application of error enhancement. |
| Control | Sham comparator | Device: DextremeThe participant will receive 6 therapy sessions of approximately 25 minutes each WITHOUT the application of error enhancement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hebrew speaker.
- First stroke (ischemic or hemorrhagic).
- Weakness on one side of the body (left or right).
- At least 21 days have passed since the stroke event.
- At least 21 days left for inpatient rehabilitative care.
Key exclusion criteria (8 listed)
- Complete paralysis of the affected side.
- Comorbid central nervous system diseases that may affect brain plasticity (MS, ALS).
- Sensory Aphasia (as per the medical diagnosis).
- One-side neglect.
- Apraxia.
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 |
|---|---|---|
| DextremeA unique 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 movement. The setting of stroke patients in a simulated environment enhances patient motivation and participation. The completion of "games" (tasks) is a great indicator for the patients that they are progressing in the treatment and are on their way to recovery. | Device | Control, Intervention |
Primary outcome
Fugl-Meyer Assessment #1
Time frame: 1 session up to 96 hours prior to first treatment session
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. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. This study will utilize the Fugl-Meyer Assessment only for the paretic upper limb. The assessment scores will range from 0 to 66, with a lower score indicating higher impairment. A minimum score of 10 will be set as an inclusion criterion.
Fugl-Meyer Assessment #2
Time frame: 1 session up to 96 hours after last (6th) treatment session
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. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. This study will utilize the Fugl-Meyer Assessment only for the paretic upper limb. The assessment scores will range from 0 to 66, with a lower score indicating higher impairment. A minimum score of 10 will be set as an inclusion criterion.
Motor Assessment Scale (MAS) #1
Time frame: 1 session up to 96 hours prior to first treatment session
The Motor Assessment Scale (MAS) is a performance-based scale used to assess everyday motor function in patients with stroke. It is a validated tool comprised of 18 tasks for the upper limbs. Each task is given a score of 0 (unable to perform) to 1 (able to perform), and the overall score ranges from 0 to 18. This assessment will be applied to both upper limbs.
Motor Assessment Scale (MAS) #2
Time frame: 1 session up to 96 hours after last (6th) treatment session
The Motor Assessment Scale (MAS) is a performance-based scale used to assess everyday motor function in patients with stroke. It is a validated tool comprised of 18 tasks for the upper limbs. Each task is given a score of 0 (unable to perform) to 1 (able to perform), and the overall score ranges from 0 to 18. This assessment will be applied to both upper limbs.
Box and Block Test (BBT) #1
Time frame: 1 session up to 96 hours prior to first treatment session
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including patients with stroke. During the assessment, the subject sits at a table in front of a box with two parts. The first part has 150 blocks, while the second part is empty. The participant must move as many blocks as he can (one at a time) in 60 seconds. The final score is the number of blocks he was able to move (out of a possible score of 150).
Box and Block Test (BBT) #2
Time frame: 1 session up to 96 hours after last (6th) treatment session
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including patients with stroke. During the assessment, the subject sits at a table in front of a box with two parts. The first part has 150 blocks, while the second part is empty. The participant must move as many blocks as he can (one at a time) in 60 seconds. The final score is the number of blocks he was able to move (out of a possible score of 150).
Modified Ashworth Scale #1
Time frame: 1 session up to 96 hours prior to first treatment session
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.
Modified Ashworth Scale #2
Time frame: 1 session up to 96 hours after last (6th) treatment session
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Rami Mansour, MD principal investigator
Reuth Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextreme in people with CVA (Cerebrovascular Accident) and Paresis, run by Reuth Rehabilitation Hospital 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 8 inclusion and 8 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 4 Jan 2022. 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. Some participants in this study may receive a placebo. 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 Rami Mansour, MD (+972732701610, rami.mansour@reuth.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment #1 (time frame: 1 session up to 96 hours prior to first treatment session). The study lists 8 primary outcomes in all. 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 4 Jan 2022.