Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients

Summary

Stroke is the third most common cause of death and the main cause of acquired adult disability in high-income countries. The most common deficit after stroke is motor impairment of the contralateral arm, with more than 80% of stroke survivors experiencing this condition in the acute phase, and only half regaining some useful upper limb function after six months.

Within the European project RETRAINER (grant agreement No 644721), the consortium developed a platform for the rehabilitation of the upper limb after stroke, which combines a passive arm exoskeleton for weight relief supporting both shoulder and elbow movements, Functional Electrical Stimulation (FES) of the two-most impaired muscles of the affected side, interactive objects, and voluntary effort. The system also provides a graphical user interface which helps the therapist set the training session and save the training data and parameters, and provides the subject a visual feedback about his/her active involvement in the exercise. The training consists of the execution of a series of exercises involving the affected arm during daily life activities. Typical exercises are anterior reaching on a plane or in the space, moving an object on a plane or in the space, moving the hand to the mouth, with or without an object in the hand, and lateral elevation of the shoulder.

The aim of this clinical study it to evaluate the efficacy of this novel training platform on patients between two weeks and nine months after their first stroke, who preserved at least a visible muscle contraction for the arm and shoulder muscles. Participants are randomized in an experimental and a control group. The control group is trained with an advanced rehabilitative program, including physical training, occupational therapy, FES, and virtual reality, while the experimental group is trained with the RETRAINER system for about 30 minutes, in addition to the same program of the control group. The daily training time is the same for the two groups. The intervention consists of three sessions a week for nine weeks. Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week follow-up visits. It is planned to recruit 68 subjects for this study.

Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which supports task-oriented repetitive training, a close temporal association between motor intention and stimulated motor response, and an intensive and frequent training paradigm, the study's hypothesis is that the experimental group shows a greater treatment effect than the control group.

Conditions

• Stroke

Interventions

DEVICE

RETRAINER-S1

It consists of the execution of different exercises with the affected arm supported by the RETRAINER-S1 device. The subject is actively involved in the exercises and the system provides two types of support: weight relief and FES. The following exercises can be performed: * anterior reaching (in a plane or in the space) * lateral elevation of the arm * hand to mouth movements with or without an object in the hand * moving objects on a plane or in the space. A subset of exercises is defined based on the patient's capability and the training time is equally shared between the selected exercises. The different training sessions can include different exercises and a different number of repetition for each exercise.

OTHER

Conventional therapy

It consists of a combination of different treatment modalities among the following, based on the petient's specific needs: * Upper limb passive motion * Arm Cycle ergometer with or without FES * Neuro Muscular Electrical Stimulation * Upper limb exercises using augmented or virtual reality environment * Occupational therapy exercises * Constraint induced movement therapy * Upper limb active movement (reaching, grasping, elevation, spatial orientation) * Repetitive task training * Mirror therapy * Writing training * Chemodenervation Therapy

Sponsors & Collaborators

• Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

  collaborator OTHER

• Ab.Acus

  collaborator OTHER

• Control Systems Group, Technische Universität Berlin, Germany

  collaborator OTHER

• Ottobock Health Products GmbH, Wien, Austria

  collaborator UNKNOWN

• Technische Universität Wien, Austria

  collaborator UNKNOWN

• HASOMED GmbH

  collaborator OTHER

• Asklepios Neurological Clinic Falkenstein

  collaborator OTHER

• Ecole Polytechnique Fédérale de Lausanne

  collaborator OTHER

• Villa Beretta Rehabilitation Center

  lead OTHER

Principal Investigators

• Franco Molteni, MD · Villa Beretta Rehabilitation Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-10

Primary Completion

2018-04-30

Completion

2018-05-31

Countries

• Germany
• Italy

Study Locations