StrokeRiSESNCT03019744
Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients
A study testing MeCFES-assisted task-oriented upper limb rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MeCFES-assisted task-oriented upper limb rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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°
Who cannot join
- 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
About this study
Official 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)
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.
- Conditions
- Stroke
- Being tested
- MeCFES-assisted task-oriented upper limb rehabilitation, Usual Care task-oriented upper limb rehabilitation
- Keywords
- Functional Electrical Stimulation, Cerebrovascular accident, Stroke, Electromyography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeCFES-assisted task-oriented upper limb rehabilitationDevice
Usual Care task-oriented upper limb rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| MeCFES | Experimental | 25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation Receives: Device: MeCFES-assisted task-oriented upper limb rehabilitation |
| Control | Active comparator | 25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation Receives: Other: Usual Care task-oriented upper limb rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks (post-treatment vs pre-treatment)
Change Score of FMA-UE Scale Between Two Time Points: 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
Measured: 5 weeks (post-treatment vs pre-treatment)
Secondary outcomes (3)
Change Score of IPPA Between Two Time Points: 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.
Measured: 5 weeks (post-treatment vs pre-treatment)
Change Score of DASH Between Two Time Points: 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.
Measured: 5 weeks (post-treatment vs pre-treatment)
Change Score of VAS for Perceived Pain Between Two Time Points: 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).
Measured: 5 weeks (post-treatment vs pre-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startApr 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Principal investigator, Maurizio Ferrarin, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Maurizio Ferrarin, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019744
- Sponsor's protocol ID
- RISES
- Acronym
- RiSES
- Status last verified
- Sep 2018
- First submitted
- 11 Jan 2017
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
PubMed 12392340Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03019744
- Acronym / sponsor ID
- RiSES / RISES
- Conditions
- Stroke
- Keywords
- Functional Electrical Stimulation, Cerebrovascular accident, Stroke, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- Apr 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 27 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MeCFES | Experimental | Device: MeCFES-assisted task-oriented upper limb rehabilitation25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation |
| Control | Active comparator | Other: Usual Care task-oriented upper limb rehabilitation25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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°
Key exclusion criteria (8 listed)
- epilepsy
- severe spasticity at upper limb (>= 3 Ashworth scale)
- implanted electronic device
- respiratory insufficiency
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeCFES-assisted task-oriented upper limb rehabilitation | Device | MeCFES |
| Usual Care task-oriented upper limb rehabilitation | Other | Control |
Primary outcome
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.
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
3 secondary outcomes
Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
Time frame: 5 weeks (post-treatment vs pre-treatment)
Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
Time frame: 5 weeks (post-treatment vs pre-treatment)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12392340van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- BackgroundWessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15
- BackgroundKennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Ferrarin, PhD principal investigator
Fondazione Don Carlo Gnocchi ETS
Questions about this trial
What is this clinical trial studying?
A study testing MeCFES-assisted task-oriented upper limb rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment (time frame: 5 weeks (post-treatment vs pre-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019744, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.