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NCT Number: NCT05902910

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest

Brest, 29200, France

Location status: Recruiting

Location contact

Olivier Remy-Neris, PU-PH

CONTACT

[email protected]

+332 98 22 31 52

Olivier Remy-Neris, PU-PH

PRINCIPAL_INVESTIGATOR

About this study

This is a pilot study following a single case experimental design with multiple baselines across subjects (MBD).

People included in the protocol will benefit from 2 hours of daily treatment during 6 to 7.5 weeks. The first 2 weeks will be dedicated to baseline measurement of their upper limb (UL) status with daily treatment for balance and gait control without any treatment of the upper limb. The rest of the time will be dedicated to upper limb treatment exclusively. It will be divided into 2 UL training periods, one of them including a 30mn treatment with the luna EMG robot. The duration of second period will be randomly defined between 2 to 3.5 weeks and the last period will last 2 weeks. The treatment during the first UL treatment period will be randomly allocated to Luna EMG treatment or not. The next period will thus follow the inverse scheme (without if the first contains Luna EMG treatment). The fluidity will be assessed through pointing movements assessed every two days. Evaluation of motor deficiency (Fugl Meyer) and functional status (ARAT score) of the UL will be weekly assessed after the inclusion visit. 3D motion analysis of the UL will also be weekly performed.

All patients will benefit from a regular follow-up and from an organized care protocol. The sessions will be intensive, all subjects will be able to benefit from the new treatment (LUNA EMG). We can expect a direct individual benefit from the proposed intensive treatment, at least for precision of UL movements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Fluidity of the upper limb

    Time frame: up to 7.5weeks

    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.

Secondary outcomes

  1. Pain assessment

    Time frame: up to 7.5weeks

    Use of Visual Analog Scale (VAS) to evaluate the painful (between 0: no pain to 10: intolerable pain)

  2. Motricity assessment

    Time frame: up to 7.5weeks

    Use of the Fugl-Meyer index (between 0: no motricity to 66: total member motricity)

  3. Function assessment

    Time frame: up to 7.5weeks

    ARAT (Action Research Arm Test) measurement to assess specific changes in limb function (from 0 to 57, a low score indicating that the movements cannot be performed, and a high score indicating normal performance)

  4. Duration of movement

    Time frame: up to 7.5weeks

    Kinematic parameter measured 3 times per week

  5. Straightness of movement

    Time frame: up to 7.5weeks

    Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The smoothness of the trajectory will be measured by the SPARC (spectral arc length measure) during forward and backward movement.

  6. Average speed of movement

    Time frame: up to 7.5weeks

    Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The spatiotemporal parameters (time, distance, average speed) will be measured between the starting position (in front of the trunc) and the final pointed object during forward and backward movement.

  7. Acceptability of the use of the robot

    Time frame: up to 7.5weeks

    Score between 0 to 100 (a low score indicate that the robot is not well accepted, and a high score indicate a well acceptability)

  8. Satisfaction of the use of the robot

    Time frame: up to 7.5weeks

    Score between 0 to 100 (0: not satisfied, 100: very satisfied)

  9. Spasticity

    Time frame: up to 7.5weeks

    Ashworth scale measured 3 times a week and Nottingham scale measured 1 time at inclusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Gwenaël Cornec, MD

CONTACT

[email protected]

Olivier Remy-Neris, PU-PH

CONTACT

[email protected]

+33 2 98 22 31 52

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • EGZOTech

Registry information

Official study title

Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.

Acronym: LUNASTROKE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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