Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

Stroke Clinical Trial

— RiSES  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019744
• Other study ID #: RISES
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: November 2015

Study information

• Verified date: September 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• MeCFES-assisted task-oriented upper limb rehabilitation

Other:
• Usual Care task-oriented upper limb rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Istituto Di Ricerche Farmacologiche Mario Negri

References & Publications (4)

Fugl-Meyer AR, Jääskö 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. — View 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.

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Score of ARAT Scale Between Two Time Points: 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)
Primary	Change Score of FMA-UE Scale Between Two Time Points: 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	Change Score of IPPA Between Two Time Points: 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)
Secondary	Change Score of DASH Between Two Time Points: 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)
Secondary	Change Score of VAS for Perceived Pain Between Two Time Points: 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)