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

NCT06010823 | Unknown

• 1 other identifier: 0013-22-RRH
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Brain Injuries; Paresis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ARAT score

  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 Outcomes (9)

• Box and Block Test (BBT)

  4 months

• Pinch test

  4 months

• Fugl-Meyer Assessment

  4 months

• Functional Ambulatory Category

  4 months

• Trunk control test

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

All participants allocated to this study group will undergo rehabilitation according to each medical center's standard rehabilitation practice.

Interventions

PlaXtreme DEVICE

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead
• Loewenstein Hospital: collaborator
• BioXtreme: collaborator

Study Sites (2)

Loewenstein Rehabilitation Center

Raanana, Israel

RECRUITING

Reuth Rehabilitation Hospital

Tel Aviv, 6902732, Israel

RECRUITING

MeSH Terms

Conditions

Stroke; Brain Injuries; Paresis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; 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

CONTACT

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

Zoya Katzir, MSc

CONTACT

+972732701610; zoya.katzir@reuth.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-08

Locations

IL (2)