Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients

Official title

Pilot Study on the Effects Induced by an Electromyographic-controlled Functional Electrical Stimulator (FitFES) for Upper Limb Rehabilitation in Post-stroke Patients

Overview

Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.

Detailed description

FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.

All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.

Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.

Interventions

• Device EMG-based FES rehabilitation
  Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device.
• Other Traditional rehabilitation
  Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises.

Primary outcome measures

• Action Research Arm Test (ARAT) [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)]
• Fugl-Meyer Upper Extremity scale (FM-UE) [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)]
• Box and Block test (BBT) [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)]
• EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)]

Secondary outcome measures (4)

• Surface Electromyography (EMGs) [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)]
• Body Kinematics [Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1)]
• Treatment Safety [Time frame: After 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)]
• Cost-effectiveness ratio [Time frame: At the end of 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)]

Eligibility criteria

Inclusion criteria

• 18 years or older
• Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
• Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
• Signed informed consent

Exclusion criteria

• Score at the Mini Mental State Examination (adjusted for age and schooling) < 24
• Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
• Major head trauma
• Cardio-respiratory or internal clinical instability
• State of pregnancy or lactation
• Severe spasticity (Ashworth > 3)
• Skin integrity problems at the interface surface with the device
• Implanted electronic devices
• Epilepsy not medically controlled
• Severe peripheral neuropathy
• Recent interventions
• Thrombosis, thrombophlebitis
• Active stent carrier less than six months
• Severe forms of arteriosclerosis, arterial circulatory disorders
• Hypertension not treated
• Cardiac arrhythmias
• Hemorrhagic disorders (hemophilia)
• Severe forms of diabetes mellitus
• Known allergy to materials making up the device or its applied parts
• Cancer or tumour disease
• Acute arthritis
• Other neurological diseases other than stroke
• Progressive muscular dystrophy
• Abdominal or inguinal hernias
• Undiagnosed back pain
• Diseases of internal organs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 3 centers

• Ospedale Policlinico San Martino — Genova
• Fondazione Don Carlo Gnocchi Onlus — La Spezia
• IRCCS Fondazione Don Carlo Gnocchi Onlus — Milan

Publications

• Villepinte C, Verma A, Dimeglio C, De Boissezon X, Gasq D. Responsiveness of kinematic and clinical measures of upper-limb motor function after stroke: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2021 Mar;64(2):101366. doi: 10.1016/j.rehab.2020.02.005. Epub 2020 Mar 7. PMID 32156646
• de los Reyes-Guzman A, Dimbwadyo-Terrer I, Trincado-Alonso F, Monasterio-Huelin F, Torricelli D, Gil-Agudo A. Quantitative assessment based on kinematic measures of functional impairments during upper extremity movements: A review. Clin Biomech (Bristol). 2014 Aug;29(7):719-27. doi: 10.1016/j.clinbiomech.2014.06.013. Epub 2014 Jun 26. PMID 25017296
• Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14. PMID 23155178
• Tropea P, Monaco V, Coscia M, Posteraro F, Micera S. Effects of early and intensive neuro-rehabilitative treatment on muscle synergies in acute post-stroke patients: a pilot study. J Neuroeng Rehabil. 2013 Oct 5;10:103. doi: 10.1186/1743-0003-10-103. PMID 24093623
• Yang N, An Q, Kogami H, Yamakawa H, Tamura Y, Takahashi K, Kinomoto M, Yamasaki H, Itkonen M, Shibata-Alnajjar F, Shimoda S, Hattori N, Fujii T, Otomune H, Miyai I, Yamashita A, Asama H. Temporal Features of Muscle Synergies in Sit-to-Stand Motion Reflect the Motor Impairment of Post-Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2019 Oct;27(10):2118-2127. doi: 10.1109/TNSRE.2019.2939193. Ep PMID 31494552
• Overduin SA, d'Avella A, Roh J, Carmena JM, Bizzi E. Representation of Muscle Synergies in the Primate Brain. J Neurosci. 2015 Sep 16;35(37):12615-24. doi: 10.1523/JNEUROSCI.4302-14.2015. PMID 26377453
• Golicki D, Niewada M, Buczek J, Karlinska A, Kobayashi A, Janssen MF, Pickard AS. Validity of EQ-5D-5L in stroke. Qual Life Res. 2015 Apr;24(4):845-50. doi: 10.1007/s11136-014-0834-1. Epub 2014 Oct 28. PMID 25347978
• Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876. PMID 9341688

Identifiers

NCT: NCT06928857 · RAISE-FITFES-RCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗