Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMED-EL Elektromedizinische Geräte GesmbH

About this trial

This study will compare two treatments that may help participants recover after having suffered from stroke. Persons who experience weakness or paralysis of their arms/hands will be randomly placed in one of two groups. Each receives treatment five times a week for three weeks. One group will be treated with electrostimulation following a cyclic pattern (control treatment), the other group will be treated with electrostimulation triggered by nerve signals (i.e. stimulation starts when they deliberately try to move their arm (investigational treatment). Before and after the three weeks and additionally 12 weeks later, the ability to move the arm and hand will be documented with standardized tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First-time ischemic stroke with moderate arm paresis (Motricity Index - UE Sum-Score ≥ 40 ≤ 77 points) (Collin & Wade, 1990)

Early to late subacute phase (7 days - 6 months) (Bernhardt et al., 2017)

Existing ADL ability before the event (ICF d5 self-care, d6 domestic life, extent of problem ≤1 points) (WHO, 2001)

Age ≥18 - 99 years

Disqualifiers

Lack of compliance with any inclusion criteria

Implanted defibrillators, brain stimulators, pacemakers, medication pumps

Therapy-resistant epilepsy

Fever or infectious diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyclic single channel neuromuscular stimulation

    Device

    Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions

  • Electromyogram-triggered 4 channel neuromuscular stimulation

    Device

    EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Cyclic Neuromuscular Electrical Stimulation (cNMES)Active comparator 1 intervention
Group B: Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stroke Impact Scale (SIS) subscale Recovery

Scores between 0 and 100, higher meaning a better outcome

Time frame
pre-intervention to 3 weeks

Secondary outcomes

1

Stroke Impact Scale (SIS), subscale strength

Scores between 0 and 100, higher meaning a better outcome

Time frame
pre-intervention to 3 weeks
2

Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL)

Scores between 0 and 100, higher meaning a better outcome

Time frame
pre-intervention to 3 weeks
3

Stroke impact scale (SIS) subscale mobility

Scores between 0 and 100, higher meaning a better outcome

Time frame
pre-intervention to 3 weeks
4

Stroke impact scale (SIS) subscale hand function

Scores between 0 and 100, higher meaning a better outcome

Time frame
pre-intervention to 3 weeks

Other outcomes

Sponsors and contacts

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