Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients

NCT05174676 | Unknown

• 1 other identifier: 0012-21-RRH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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,

Conditions

CVA (Cerebrovascular Accident); Paresis

Keywords

Brain plasticity; Upper limb function; Robotic rehabilitation; Error augmentation or enhancement

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  1 session up to 96 hours after last (6th) treatment session

Study Arms (2)

Intervention

EXPERIMENTAL

The participant will receive 6 therapy sessions of approximately 25 minutes each WITH the application of error enhancement.

Device: Dextreme

Control

SHAM COMPARATOR

The participant will receive 6 therapy sessions of approximately 25 minutes each WITHOUT the application of error enhancement.

Device: Dextreme

Interventions

Dextreme DEVICE

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, 6902732, Israel

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rami Mansour, MD

  Reuth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Mansour, MD

CONTACT

+972732701610; rami.mansour@reuth.org.il

Beth Zalcman, MPH

CONTACT

+972732701610; beth.zalcman@reuth.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 3, 2022
• Study Start: December 20, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)