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

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

Interventions

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.

Sponsors & Collaborators

• Loewenstein Hospital

  collaborator OTHER

• BioXtreme

  collaborator UNKNOWN

• Reuth Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Rami Mansour, MD · Reuth Rehabilitation Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-30

Primary Completion

2024-09-30

Completion

2024-12-31

Countries

• Israel

Study Locations