Use of neuromodulation system and assistive devices for rehabilitation of upper limb motor function after stroke

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12843006

Enrollment

Registered

2017-03-23

Start date

2016-02-01

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System Stroke

Interventions

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 s

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026