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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03019744

Acronym

RiSES

Enrollment

Registered

2017-01-13

Start date

2011-04-30

Completion date

2015-11-30

Last updated

2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Functional Electrical Stimulation, Cerebrovascular accident, Stroke, Electromyography

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.

Interventions

DEVICEMeCFES-assisted task-oriented upper limb rehabilitation

OTHERUsual Care task-oriented upper limb rehabilitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Participant flow

Participants by arm

Arm	Count
MeCFES 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation MeCFES-assisted task-oriented upper limb rehabilitation	38
Control 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Usual Care task-oriented upper limb rehabilitation	44
Total	82

Baseline characteristics

Characteristic	MeCFES	Control	Total
Age, Continuous	66.2 years STANDARD_DEVIATION 12.9	67.1 years STANDARD_DEVIATION 13.8	66.6 years STANDARD_DEVIATION 13.3
Sex: Female, Male Female	21 Participants	22 Participants	43 Participants
Sex: Female, Male Male	17 Participants	22 Participants	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 32	0 / 36
serious Total, serious adverse events	0 / 32	0 / 36

Outcome results

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.