Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke

NCT05902910 | Recruiting

• 2 other identifiers: 29BRC21.03932022-A00096-37
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Recent work on large cohorts of chronic stroke (\>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention. A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention. Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects. We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.

Conditions

Stroke

Keywords

Robot; Joint

Outcome Measures

Primary Outcomes (1)

• Fluidity of the upper limb

  Repeated evaluation of hand movement by the SPARC index during five pointing tasks at 90% of the length of the upper limb at clavicle height, at comfortable speed.

  up to 7.5weeks

Secondary Outcomes (9)

• Pain assessment

  up to 7.5weeks

• Motricity assessment

  up to 7.5weeks

• Function assessment

  up to 7.5weeks

• Duration of movement

  up to 7.5weeks

• Straightness of movement

  up to 7.5weeks

Study Arms (2)

Experimental Scheme : A,B,C

ACTIVE COMPARATOR

The phase B treatment (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot) is scheduled before phase C (2 hours a day, 5/7 days of conventional rehabilitation). The duration of phase B is randomized between 6 and 11 evaluations (2 to 3.5 weeks).

Device: LUNA-EMG Robot

Experimental Scheme : A,C,B

ACTIVE COMPARATOR

The phase C treatment (2 hours a day, 5/7 days of conventional rehabilitation) is scheduled before phase B (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot). The duration of phase C is randomized between 6 and 11 evaluations (2 to 3.5 weeks).

Device: LUNA-EMG Robot

Interventions

LUNA-EMG Robot DEVICE

During phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot.

Experimental Scheme : A,B,C; Experimental Scheme : A,C,B

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• Hemiparesis after a first stroke with more than 1 year time interval
• Functional upper limb: ability to do a pointing task at 90% of the hand-acromion distance (free trunk).
• Spastic hypertonia of the elbow flexors 0-2/4 on the Modified Ashworth scale
• Patient affiliated with social security
• Patient having signed a consent to participate in the research

You may not qualify if:

• Inability to sign written consent
• Flexed elbow \> 30° during passive mobilization of the upper limb
• EVA\>3 in the upper limb at rest or during mobilization
• Complete loss of upper limb proprioception
• Neuro-orthopedic surgery of the upper limb for spasticity: neurotomy, tenotomy, transfer
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• University Hospital, Brest: lead
• EGZOTech: collaborator

Study Sites (1)

CHU Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier Remy-Neris, PU-PH

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Remy-Neris, PU-PH

CONTACT

+33 2 98 22 31 52; olivier.remyneris@chu-brest.fr

Gwenaël Cornec, MD

CONTACT

gwenael.cornec@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will not know what phase the patient is in at the time of assessment or what experimental design the patient was randomized to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The multiple-baseline SCED design is a prospective design that allows the intensive study of a few individuals to measure their baseline and condition related to a therapeutic intervention. Each subject is his own control with repeated measurements of the primary endpoint. Randomization in the MBD formats of SCED studies relates to the duration of the phases. The experimental plan includes 3 rehabilitation phases: A (Baseline), B (1.5hours a day 5/7 of conventional rehabilitation and 30mn of training with the Luna robot 5/7) and C (2 hours a day 5/7 of conventional rehabilitation). The duration of phase A is fixed (2 weeks). As the effect of the treatment on the upper limb is unknown in its latency, the duration of the second phase of the study will be randomized (2 to 3.5 weeks). Finally, the duration of the third phase is fixed (2 weeks)

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: June 15, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)