- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019744
Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients (RiSES)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MeCFES
25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
|
|
ACTIVE_COMPARATOR: Control
25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
5 weeks (post-treatment vs pre-treatment)
|
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 |
5 weeks (post-treatment vs pre-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
|
IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000). IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome. |
5 weeks (post-treatment vs pre-treatment)
|
Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
|
DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100.
Higher scores mean worse outcome.
|
5 weeks (post-treatment vs pre-treatment)
|
Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
|
VAS: Visual Analogic Scale for perceived pain on a 10-level scale.
VAS minimum value is 0 and maximum value is 10.
Higher scores mean worse outcome (more severe pain).
|
5 weeks (post-treatment vs pre-treatment)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maurizio Ferrarin, PhD, Fondazione Don Carlo Gnocchi Onlus
Publications and helpful links
General Publications
- 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.
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RISES
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