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

Sponsor

University Hospital, Brest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05902910

Collaborator

EGZOTech (Industry)

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: LUNA-EMG Robot	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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)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)

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors will not know what phase the patient is in at the time of assessment or what experimental design the patient was randomized to.

Primary Purpose:

Supportive Care

Official 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.

Anticipated Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental Scheme : A,B,C 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 During phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot.
Active Comparator: Experimental Scheme : A,C,B 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 During phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot.

Arm

Intervention/Treatment

Active Comparator: Experimental Scheme : A,B,C

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

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

Active Comparator: Experimental Scheme : A,C,B

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

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

Outcome Measures

Primary Outcome Measures

Fluidity of the upper limb [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 Outcome Measures

Pain assessment [up to 7.5weeks]
Use of Visual Analog Scale (VAS) to evaluate the painful (between 0: no pain to 10: intolerable pain)
Motricity assessment [up to 7.5weeks]
Use of the Fugl-Meyer index (between 0: no motricity to 66: total member motricity)
Function assessment [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)
Duration of movement [up to 7.5weeks]
Kinematic parameter measured 3 times per week
Straightness of movement [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.
Average speed of movement [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.
Acceptability of the use of the robot [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)
Satisfaction of the use of the robot [up to 7.5weeks]
Score between 0 to 100 (0: not satisfied, 100: very satisfied)
Spasticity [up to 7.5weeks]
Ashworth scale measured 3 times a week and Nottingham scale measured 1 time at inclusion)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Brest	Brest		France	29200

Sponsors and Collaborators

University Hospital, Brest
EGZOTech

Investigators

Principal Investigator: Olivier Remy-Neris, PU-PH, CHRU Brest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT05902910

Other Study ID Numbers:

29BRC21.0393
2022-A00096-37

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

Robot

Joint

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 15, 2023