Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients ( RETRAINER-S2 )

NCT03199833 | Unknown

• 1 other identifier: RETRAINER-S2
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 2

Brief 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 forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand flexor muscles and of the extrinsic hand extensor muscles, 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 include controlled wrist flexion and extension, controlled fingers flexion and extension, anterior reaching and grasping on a plane or in the space, moving an object on a plane or in the space. 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

Keywords

rehabilitation; orthosis; functional electrical stimulation; electrode array; upper limb; sub-acute; motor relearning

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

  9-item outcome measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: * 3: Performs test normally * 2: Completes test, but takes abnormally long or has great difficulty * 1: Performs test partially * 0: Can perform no part of test

  9 weeks

Secondary Outcomes (10)

• Action Research Arm Test

  13 weeks

• Medical Research Council

  baseline; 9 weeks; 13 weeks

• Motricity index

  baseline; 9 weeks; 13 weeks

• Motor Activity Log

  baseline; 9 weeks; 13 weeks

• Box & Blocks Test

  baseline; 9 weeks; 13 weeks

Study Arms (2)

Arms

EXPERIMENTAL

RETRAINER-S2 \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the RETRAINER-S2 system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Device: RETRAINER-S2; Other: Conventional therapy

Conventional Therapy

ACTIVE COMPARATOR

27 sessions, 3 sessions per week for a total of 9 weeks. Each session lasts about 90 minutes and consists of different training modalities typically used in the rehabilitation of the arm after stroke. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Other: Conventional therapy

Interventions

RETRAINER-S2 DEVICE

It consists of the execution of different exercises with the affected forearm-hand supported by the RETRAINER-S2 device. The subject is actively involved in the exercises and the system provides two types of support: wrist-fingers motion constraining and FES. The following exercises can be performed: controlled wrist flexion and wrist extension; controlled fingers flexion and extension; repeated grasping of an object; anterior reaching and grasping of an object; moving of objects on a plane or in 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.

Arms

Conventional therapy OTHER

It consists of a combination of different treatment modalities among the following, based on the patient'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

Arms; Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults male and/or female, 18-85 years old
• Patients who have suffered a first stroke with major unilateral functional impairment
• Acute event between two weeks and nine months before study enrollment
• Motricity Index of the affected side must be under 80% of best expected performance.
• No major contralateral impairment must be present (Motricity Index of the non-affected side more than 80% of normality)
• Residual muscular activity for forearm muscles (MRC \> o = 1)
• Mini-Mental State Examination \> 20

You may not qualify if:

• Limitation for using the device due to impairment of Passive Range of Motion and/or
• Pain due to Spasticity evaluated using Modified Ashworth Scale
• Previous history of major neurological or psychiatric disorders
• allergy to electrodes

Sponsors & Collaborators

• Dr. Franco Molteni: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Ab.Acus: collaborator
• Control Systems Group, Technische Universität Berlin, Germany: collaborator
• Ottobock Health Products GmbH, Wien, Austria: collaborator
• HASOMED GmbH: collaborator
• Asklepios Neurological Clinic Falkenstein: collaborator
• Technische Universität Wien, Austria: collaborator
• Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy: collaborator

Study Sites (2)

Asklepios Neurologische Klinik Falkenstein

Königstein im Taunus, 61462, Germany

RECRUITING

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

RECRUITING

Related Links

• Official web site of the project

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Franco Molteni, MD

  Villa Beretta Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Palumbo

CONTACT

+390318544215; gpalumbo@valduce.it

Mauro Rossini

CONTACT

+390318544217; mrossini@valduce.it

Study Design

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

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: November 10, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (1)