Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis

NCT04014270 | Terminated

• 3 other identifiers: 2018-0240210000465CIV-CH-19-02-027064
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis. The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC). SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.

Conditions

Stroke Rehabilitation

Keywords

Electrical stimulation; Upper limb rehabilitation; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Change in the motor part of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale, calculated from baseline to post-intervention (2 weeks)

  The FMA-UE measures the upper limb motor impairment. FMA-UE consists of 33 items. Each item is scored on a 3-point ordinal scale (0, 1, and 2) with 0 generally corresponding to no function, 1 to partial function, and 2 to perfect function. The items are summed to the final maximal score of 66 (no impairment).The FMA may also be divided into shoulder/elbow and wrist/hand sub-scores consisting of 18 and 15 tasks, with a maximum score of 36 and 30, respectively. Higher scores indicate less impairment.

  From baseline to post-intervention (2 weeks)

Secondary Outcomes (5)

• Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)

  At 3 months (T3) compared to baseline (T0)

• Number and proportion of patients with change of at least 5 FMA-UE points from baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up

  From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up

• Change of upper limb function measured by the Action Research Arm test (ARAT) from baseline to post-intervention (2 weeks) and to 3 months follow-up

  From baseline to post-intervention (2 weeks) and to 3 months follow-up

• Change of perceived upper limb function measured by the Motor Activity Log (MAL) from baseline to post-intervention (2 weeks) and to 3 months follow-up

  From baseline to post-intervention (2 weeks) and to 3 months follow-up

• Change of hand and arm spasticity measured by the REsistance to PASsive movement (REPAS) from baseline to post-intervention (2 weeks) and to 3 months follow-up

  From baseline to post-intervention (2 weeks) and to 3 months follow-up

Study Arms (2)

Self modulated functional electrical stimulation (SM-FES)

EXPERIMENTAL

Patients will receive self-modulated functional electrical stimulation SM-FES

Device: Self-modulated functional electrical stimulation (SM-FES)

Standard care (SC)

ACTIVE COMPARATOR

Patients will receive standard care, dose matched to the experimental group therapy

Other: Standard Care

Interventions

Self-modulated functional electrical stimulation (SM-FES) DEVICE

The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. A device called the Intento PRO will be used to deliver the experimental treatment. Duration: 90 min per day, 5 days per week, for 2 weeks.

Self modulated functional electrical stimulation (SM-FES)

Standard Care OTHER

The patient performs intensive, goal-oriented, repetitive functional exercises. Duration: 90 min per day, 5 days per week, for 2 weeks.

Standard care (SC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of one, first-ever ischemic stroke verified by brain imaging (i.e. computed tomography or magnetic resonance imaging);
• chronic impairment after stroke, i.e. time since event ≥ 6months;
• severe and severe-moderate upper limb impairment, i.e. FMA-UE score ≤ 34;
• ≤ age \< 80;
• ability to give consent, understand the device use and follow instructions.

You may not qualify if:

• an unstable recovery stage, measured as a difference between screening and baseline examinations of more than 3 points in the motor part of the FMA-UE scale;
• contraindications and risk factors to neuromuscular electrical stimulation;
• severe hemi-spatial neglect or anosognosia involving the affected arm, as determined by the Bells tests (\> 6 errors);
• severe impairment of proprioception, as evaluated from the blinded detection and discrimination of imposed passive movements (≥ 20° extension or flexion) of the finger proximal joint (\>3 errors out of 6 mobilisations);
• severe impairment of tactile sensing in the hand, as assessed by Semmes-Weinstein monofilament test (no detection of the 5.88 size evaluator);
• excessive spasticity, as indicated by a score \> 2 in any of the items of the REsistance to PASsive movement (REPAS) arm subtest;
• recurrent, moderate to high upper limb pain limiting delivery of rehabilitation dose, i.e. pain at rest and in correspondence of a passive range of motion lower than 50%;
• botulinum toxin injection into affected upper extremity during 3 months before the study or during the study;
• history of physical / medical conditions interfering with study procedure, for example shoulder subluxation, upper extremity injury that limits the function of the hand or arm, skin lesion/rash/open wound on the affected upper extremity, or similar;
• history of neurological condition interfering with study procedure, e.g. Parkinson's disease, progressive brain diseases like dementia and tumours;
• use of antipsychotic medications;
• enrolled in the past six months in another study involving drugs, biologics, upper limb experimental therapy, or similar.

Sponsors & Collaborators

• Intento SA: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• University Hospital, Geneva: collaborator
• KLINIK BETHESDA Tschugg: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University of Bern: collaborator
• Innosuisse - Swiss Innovation Agency: collaborator

Study Sites (4)

Centre hospitalier universitaire vaudois

Lausanne, Canton of Vaud, 1005, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Klinik Bethesda Tschugg

Tschugg, 3233, Switzerland

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the two interventions (SM-FES and SC) are different in appearance for both the participant and the therapist providing the therapy session, only the assessor (i.e., person administering the outcome tests) will be kept blinded to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: November 8, 2019
• Primary Completion: October 26, 2021
• Study Completion: May 22, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CH (4)