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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Usual Care task-oriented upper limb rehabilitation; Device: MeCFES-assisted task-oriented upper limb rehabilitation

• Registration Number: NCT03019744
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Results First Submitted: 2018-08-03
• Results First Submitted QC: 2018-08-28
• Status Verified: 2018-09
• Results First Posted: 2018-09-27
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Usual Care task-oriented upper limb rehabilitation	25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
MeCFES	MeCFES-assisted task-oriented upper limb rehabilitation	25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation

Primary Outcome Measures

Name	Time	Method
Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment	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	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 Outcome Measures

Name	Time	Method
Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment	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.
Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment	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.
Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment	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).