NCT03171649

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 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2016

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

May 22, 2017

Last Update Submit

May 28, 2017

Conditions

Stroke

Keywords

rehabilitationexoskeletonfunctional electrical stimulationupper limbsub-acutemotor re-learning

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test

    19-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

    baseline; 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

  • +5 more secondary outcomes

Study Arms (2)

RETRAINER-S1 & Conventional Therapy

EXPERIMENTAL

27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the RETRAINER-S1 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-S1Other: 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-S1DEVICE

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.

RETRAINER-S1 & Conventional Therapy
Conventional therapyOTHER

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

Conventional TherapyRETRAINER-S1 & Conventional Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 arm and shoulder 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
  • Previus history of major neurological or psychiatric disorders
  • allergy to electrodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asklepios Neurologische Klinik Falkenstein

Königstein im Taunus, 61462, Germany

RECRUITING

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

RECRUITING

Related Publications (1)

  • Ambrosini E, Gasperini G, Zajc J, Immick N, Augsten A, Rossini M, Ballarati R, Russold M, Ferrante S, Ferrigno G, Bulgheroni M, Baccinelli W, Schauer T, Wiesener C, Gfoehler M, Puchinger M, Weber M, Weber S, Pedrocchi A, Molteni F, Krakow K. A Robotic System with EMG-Triggered Functional Eletrical Stimulation for Restoring Arm Functions in Stroke Survivors. Neurorehabil Neural Repair. 2021 Apr;35(4):334-345. doi: 10.1177/1545968321997769. Epub 2021 Mar 3.

    PMID: 33655789DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Franco Molteni, MD

    Villa Beretta Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Palumbo

CONTACT

+390318544215gpalumbo@valduce.it

Mauro Rossini

CONTACT

+390318544217mrossini@valduce.it

Study Design

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

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 31, 2017

Study Start

November 10, 2016

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)IT(1)