Clinical trial NCT03019744: Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients
Official title: Studio Clinico di Efficacia Della Stimolazione Elettrica Funzionale Controllata da Segnale Elettromiografico Nel Trattamento Dell'Arto Superiore in Pazienti Con Esiti di Ictus Cerebrovascolare (Progetto Rises)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Functional Electrical Stimulation
Cerebrovascular accident
Stroke
Electromyography
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Istituto Di Ricerche Farmacologiche Mario Negri
First posted: 2017-01-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
* at least 1 month post-stroke
* willingness to participate the project
* minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test)
* passive Range of Motion (ROM) of the shoulder and elbow of more than 90°

Exclusion Criteria:

* epilepsy
* severe spasticity at upper limb (\>= 3 Ashworth scale)
* implanted electronic device
* respiratory insufficiency
* pregnancy
* peripheral neuropathies
* cutaneous ulcers at the stimulation zone
* other use of FES on the upper limb

Primary outcomes:
measure: Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
timeFrame: 5 weeks (post-treatment vs pre-treatment)
measure: Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
timeFrame: 5 weeks (post-treatment vs pre-treatment)
Secondary outcomes:
measure: Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
timeFrame: 5 weeks (post-treatment vs pre-treatment)
measure: Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
timeFrame: 5 weeks (post-treatment vs pre-treatment)
measure: Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
timeFrame: 5 weeks (post-treatment vs pre-treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Maurizio Ferrarin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
citation: Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
citation: Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.