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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Enrollment
- 82
- Primary Endpoint
- Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Maurizio Ferrarin
Dr.Eng., Ph.D.
Fondazione Don Carlo Gnocchi Onlus
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
- •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
Outcomes
Primary Outcomes
Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.
Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome
Secondary Outcomes
- Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment(5 weeks (post-treatment vs pre-treatment))
- Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment(5 weeks (post-treatment vs pre-treatment))
- Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment(5 weeks (post-treatment vs pre-treatment))