Back to resultsSelf-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis (SM-FES)
Primary Purpose
Stroke Rehabilitation
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Self-modulated functional electrical stimulation (SM-FES)
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Rehabilitation focused on measuring Electrical stimulation, Upper limb rehabilitation, Hemiplegia
Eligibility Criteria
Inclusion Criteria:
- 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;
- 18 ≤ age < 80;
- ability to give consent, understand the device use and follow instructions.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre hospitalier universitaire vaudois
- Inselspital
- Hôpitaux Universitaires de Genève
- Klinik Bethesda Tschugg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self modulated functional electrical stimulation (SM-FES)
Standard care (SC)
Arm Description
Patients will receive self-modulated functional electrical stimulation SM-FES
Patients will receive standard care, dose matched to the experimental group therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)
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.
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
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).
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
The ARAT measures of the upper limb function. It contains 19 items grouped into 4 subscales: grasp, grip, pinch and gross motor. In the first 3 subscales, the scale assessed the ability to grasp, move, and release objects of differing size, weight, and shapes. The last subtest evaluates 3 gross movements (place hand behind head, place hand on top of head, and move hand to mouth). Each item is graded on an ordinal scale from 0-3, all of which are summed to yield a score of 0 to 57. Higher scores indicate less impairment.
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
The MAL is a measure of perceived upper limb disability in activities of daily living.
The MAL-14 includes 14 items, scored on an 11-point amount of use (AOU) scale (range 0-5) to rate how much the arm is used and an 11-point quality of movement (QOM) scale (range 0-5) to rate how well patients are using their affected upper extremity.
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
The REPAS consists of several items across different defined joints, each of which are rated according to the Modified Ashworth Scale (MAS) (0 = no increase in muscle tone to 4 = limb rigid in flexion or extension), and includes assessments of the shoulder, elbow, forearm, wrist, finger. A higher score indicates more severe impairment, with a maximum upper limb score of 64.
Full Information
NCT ID
NCT04014270
First Posted
July 8, 2019
Last Updated
May 22, 2023
Sponsor
Intento SA
Collaborators
Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, KLINIK BETHESDA Tschugg, Insel Gruppe AG, University Hospital Bern, University of Bern, Innosuisse - Swiss Innovation Agency
1. Study Identification
Unique Protocol Identification Number
NCT04014270
Brief Title
Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis
Acronym
SM-FES
Official Title
Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis: A Multi-Centre, Single-Blind, Randomized Parallel Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Challenges experienced in recruitment.
Shifts in the sponsor's priorities and organizational structure resulting from its integration into a larger corporate group.
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
May 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intento SA
Collaborators
Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, KLINIK BETHESDA Tschugg, Insel Gruppe AG, University Hospital Bern, University of Bern, Innosuisse - Swiss Innovation Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
After the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria.
Each recruited participant will be randomly assigned to one group:
experimental group - patients will receive self-modulated functional electrical stimulation SM-FES;
control group - patients will receive standard care SC.
This first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up).
After the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with SM-FES.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Electrical stimulation, Upper limb rehabilitation, Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self modulated functional electrical stimulation (SM-FES)
Arm Type
Experimental
Arm Description
Patients will receive self-modulated functional electrical stimulation SM-FES
Arm Title
Standard care (SC)
Arm Type
Active Comparator
Arm Description
Patients will receive standard care, dose matched to the experimental group therapy
Intervention Type
Device
Intervention Name(s)
Self-modulated functional electrical stimulation (SM-FES)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
The patient performs intensive, goal-oriented, repetitive functional exercises.
Duration: 90 min per day, 5 days per week, for 2 weeks.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
From baseline to post-intervention (2 weeks)
Secondary Outcome Measure Information:
Title
Change of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale at 3 months (T3) compared to baseline (T0)
Description
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.
Time Frame
At 3 months (T3) compared to baseline (T0)
Title
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
Description
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE).
Time Frame
From baseline (T0) to 2 weeks (T2) post-intervention and 3 months (T3) follow-up
Title
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
Description
The ARAT measures of the upper limb function. It contains 19 items grouped into 4 subscales: grasp, grip, pinch and gross motor. In the first 3 subscales, the scale assessed the ability to grasp, move, and release objects of differing size, weight, and shapes. The last subtest evaluates 3 gross movements (place hand behind head, place hand on top of head, and move hand to mouth). Each item is graded on an ordinal scale from 0-3, all of which are summed to yield a score of 0 to 57. Higher scores indicate less impairment.
Time Frame
From baseline to post-intervention (2 weeks) and to 3 months follow-up
Title
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
Description
The MAL is a measure of perceived upper limb disability in activities of daily living.
The MAL-14 includes 14 items, scored on an 11-point amount of use (AOU) scale (range 0-5) to rate how much the arm is used and an 11-point quality of movement (QOM) scale (range 0-5) to rate how well patients are using their affected upper extremity.
Time Frame
From baseline to post-intervention (2 weeks) and to 3 months follow-up
Title
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
Description
The REPAS consists of several items across different defined joints, each of which are rated according to the Modified Ashworth Scale (MAS) (0 = no increase in muscle tone to 4 = limb rigid in flexion or extension), and includes assessments of the shoulder, elbow, forearm, wrist, finger. A higher score indicates more severe impairment, with a maximum upper limb score of 64.
Time Frame
From baseline to post-intervention (2 weeks) and to 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
18 ≤ age < 80;
ability to give consent, understand the device use and follow instructions.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Centre hospitalier universitaire vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1005
Country
Switzerland
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Klinik Bethesda Tschugg
City
Tschugg
ZIP/Postal Code
3233
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis
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