Condition category
Circulatory System
Date applied
06/03/2017
Date assigned
23/03/2017
Last edited
23/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Strokes are caused by a bleed in the brain and can be life threatening. One common consequence is upper limb impairment. This causes stroke patients to be unable to use their arms and upper body to do simple tasks such as reaching or grasping. Currently, people with stroke undergo rehabilitation, which is usually done through a physical and occupational (daily living skills) therapies to improve their mobility (movement) with their upper limbs. However, this kind of treatment has limitations and often cannot help patients regain total mobility. There are alternative rehabilitation treatments that use new methods and technologies that may be able to help patients with stroke. Neuromodulaton therapies using brain-computer interfaces (BCI), which connects brain signals directly to a computer, have the potential to help patients. This type of therapy uses assistive devices such as electrical stimulation (electrical shocks or waves) and robots to help restore function to the areas affected by stroke. The aim of this study is to evaluate and the potential benefits that can be achieved by using assistive devices in rehabilitation sessions with stroke patients.

Who can participate?
Adult subjects aged 18-65 who have had a stroke and healthy adults aged 18-65

What does the study involve?
This study involves three phases. The first phase examines the technical feasibility of the study to see how well the technology systems work. This is done using healthy participants and only a small number of participants who have had a stroke. This phase involves one to three one hour sessions that require participants to do a number of tasks such as reaching or grasping with the help of assisted devices. The second phase of this study aims to verify the cortical (a part of the brain) changes. This involves both healthy participants and a small number of participants who have had a stroke carry out tasks using a BCI to trigger the action of assistive devices or robots. This involves one to three one hour sessions. The final phase is the evaluation and it involves only participants who have had a stroke. Participants are randomly allocated to one of two groups. Those in the first group attend 12 treatment sessions that requires them to use BCI and assistive devices to help them perform tasks such as reaching or grasping. These types of tasks are repeated many times. Those in the second group receive 12 traditional physical therapy sessions as per the standard level of care. Participants are followed up at the end of the session to assess their mobility.

What are the possible benefits and risks of participating?
Participants with stroke may benefit from undergoing this rehabilitation programme. There are no notable risks with participating.

Where is the study run from?
1. Cajal Institute of the Spanish National Research Council (CSIC) (Spain)
2. Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC) (Spain)

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
Spanish National Research Council (Spain)

Who is the main contact?
Francisco Resquín
franresquin@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Francisco Resquín

ORCID ID

http://orcid.org/0000-0003-1693-6930

Contact details

Av. Doctor Arce 37
Madrid
28002
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CSEULS-PI-106/2016

Study information

Scientific title

Validation and evaluation of using functional electrical stimulation techniques, robotic devices and brain-computer interfaces for rehabilitation upper limbs motor functions in people with stroke

Acronym

Study hypothesis

The aim of this study is to evaluate the rehabilitation effects, at cortical and functional level, when using a brain-machine interface to trigger the action of assistive devices (like functional electrical stimulation -FES- and robotic devices) during the execution of functional upper limbs tasks.

Ethics approval

Clinical Ethics Committee of the Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 01/02/2016, ref: CSEULS-PI-106/2016

Study design

Phase One: Initial feasibility study
Phase Two and Three: Multi-session balanced experimental and controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Stroke

Intervention

The protocol of the study comprises of three phases.

Phase 1 Technical feasibility and usability verification: This phase includes experimentation with healthy volunteers and with a small cohort of subjects with a stroke. The intervention at this stage relies on the execution of a predefined number of a functional upper limb tasks (e.g. reaching and/or grasping) led by the assisted devices (FES and/or robots). Healthy subjects participate in a single evaluation session, while stroke subjects participate in a few evaluation sessions (no more than three). The duration of each session of either group (healthy or stroke patients) is less than 1 hour.

Phase 2 Verification of cortical changes: This stage also includes healthy participants and a small cohort of subjects with stroke. In this phase, the participants carry out a predefined number of a functional upper limb tasks (e.g. reaching and/or grasping) in which a brain-computer interfaces (BCI) trigger the action of assistive devices (FES and/or robots). Again, healthy subjects participate in a single evaluation session, while stroke subjects participate in a few evaluation sessions (no more than three). The maximum duration of each session for either group (healthy or stroke patients) is 1 hour.

Phase 3 Pre-clinical evaluation: This phase includes a multi-session pilot intervention with one experimental and one control group. For this intervention, only subjects who has suffered a stroke are recruited. Both groups participate in 12 consecutive sessions, distributed 3 sessions per week. Participants are randomly allocated to the experimental or to the control group.

Experimental group: BCI and assistive devices (FES and/or robots) are used to assist the execution of upper limb tasks. On each session, the participants are asked to perform a functional upper limb tasks (e.g. reaching and/or grasping) in which a BCI trigger the action of assistive devices (FES and/or robots). At least 50 repetitions must be accomplished in each session.

Control group: is based on traditional physical therapy. The provided therapy is matched with the provided in the experimental group in physical (muscles and joints exercised) and doze terms (same number of sessions and repetitions per session). The type of physical therapy is defined by professional experts in this field.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Phase 1:
Arm joints kinematics are measured using kinematic sensors at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one).

Phase 2:
1. Arm joints kinematics are measured using kinematic sensors at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one)
2. Motor evoked potential (MEP) induced by Transcranial magnetic stimulation is measured using the Electromyography (EMG) signal of the arm's muscles both before and after intervention at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one)

Phase 3:
1. Arm joints kinematics are measured using kinematic sensors at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12
2. Kinetics data of the arm joints under isometric condition are measured using torque sensors at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12
3. Co-contraction index of target muscles of the arm are measured using EMG signals at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12
4. Clinical outcomes are measured using the Box and block test, the Modified Answorth scale for the upper limbs and the Medical Research Council scale for upper limbs at baseline (before session one) and after the intervention (after session 12)

Secondary outcome measures

Phase 1:
User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self-Assessment Manikin (SAM) at the end of the intervention (after session three).Healthy volunteers only attend session one and are therefore only assessed at the end of the session one.

Phase 2:
1. User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self-Assessment Manikin (SAM) at the end of the intervention (after session three). Healthy volunteers only attend session one and are therefore only assessed at the end of the session one.
2. Analysis of cortical pattern is measured using the recorded EEG signals at sessions one, two and three. Healthy volunteers only attend session one and are therefore only assessed at session one.

Phase 3:
1. User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self-Assessment Manikin (SAM) at the end of the intervention (after session 12)
2. Cognitive tests are assessed using the Mini-Mental State Examination at baseline, session (before session one) and at the end of the intervention (after session 12)
3. Analysis of cortical pattern is assessed using the recorded EEG signals at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12

Overall trial start date

01/01/2016

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria for Healthy subjects:
1. Age between 18 and 65
2. Not pregnant
4. Tolerance to functional electrical stimulation of the upper limbs muscle
5. Absence of neurological lesion
6. Availability to participate to the study

Inclusion criteria for subjects with stroke:
1. Aged between 18 and 65 years old
2. Not pregnant
3. Subject with a chronic or subacute stroke
4. Without prior neurological lesion to stroke
5. With cognitive capabilities to follow instruction
6. Tolerance to functional electrical stimulation of the upper limbs muscle
7. With motor response to functional electrical stimulation
8. Availability to participate to the study

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Evidence or known history of epilepsy
2. Pregnancy
3. With implanted devices
4. Reject to sign the informed consent

Recruitment start date

01/02/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Centro de Referencia Estatal de Atención Al Daño Cerebral (CEADAC)
Calle Río Bullaque 1
Madrid
28034
Spain

Trial participating centre

Instituto de Rehabilitación Funcional (IRF) La Salle
Calle Ganimedes 11
Madrid
28023
Spain

Trial participating centre

Instituto Cajal
Avenue Doctor Arce 37
Madrid
28002
Spain

Sponsor information

Organisation

Spanish National Research Council (CSIC)

Sponsor details

Av. Doctor Arce 37
Madrid
28002
Spain

Sponsor type

Research council

Website

Funders

Funder type

Government

Funder name

Ministry of Science and Innovation (Ministerio de Ciencia e Innovación)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journals.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Francisco Resquín at franresquin@gmail.com

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes