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Completed

NCT Number: NCT03019744

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MeCFES-assisted task-oriented upper limb rehabilitation

Device

Usual Care task-oriented upper limb rehabilitation

Other

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

Registry information

Official study 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)

Acronym: RiSES

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2017
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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