Functional Eletrical Stimulation in Post Stroke Patients (FES-ABLE)
December 27, 2019 updated by: Rubim Santos, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients
The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks.
The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Porto, Portugal, 4200-072
- Center for Rehabilitation Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- First and unilateral ischemic or hemorrhagic stroke, in the middle cerebral artery, confirmed by imaging;
- Age equal ou greater than 30 years old;
- Preserved congnitive function, corresponding to a score higher than 23 in the Mini Mental State Examination (MMSE);
- Ability to perform active movement in the contralesional upper limb (UL) of at least 15° in the shoulder and elbow.
Exclusion Criteria:
- Body mass index (BMI) less than 18,5 and greater than 30;
- Hemi-spatial neglect and/or uncorrected visual changes;
- Musculoskeletal or neurological conditions which may affect ULs and/or trunk function;
- Pain in the ULs;
- Severe sensorimotor impairment, corresponding to a score less than 39 in the Fugl-Meyer Assessment Scale - Upper Extremity (FMAS-UE);
- Lesions on the skin of the affected forearm;
- Severe spasticity (modified Ashworth >3);
- Severe muscle contractures on the affected forearm;
- Pacemaker;
- Osteosynthesis or metallic implants;
- Pregnancy;
- Adverse skin reaction to electrodes' gel.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FES
Functional Eletrical Stimulation
|
Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinematic metrics change
Time Frame: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months
|
End-point kinematics and joint kinematics will be analyzed. Regarding end-point kinematics, to evaluate speed, the absolute and relative movement times will be calculated separately for each phase and for the entire tasks, as well as the peak velocity for reach, forward and backward transport and return phases. To assess efficiency, smoothness and control strategy of movement, the índex of curvature, the number of velocity peaks (or number of motor units) and the time to peak velocity will be respectively calculated for reach, forward and backward transport and return phases. Regarding joint kinematics, joint angles5 of shoulder, elbow and wrist at onset of each phase will be calculated, as well as maximum aperture and time to maximum aperture in reach and return phases, and trunk displacement (to measure compensation) for each phase. |
Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User satisfaction
Time Frame: User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months
|
Participants' satisfaction will be assessed through an adaptation of the Reduced Upper Extremity Motor Activity Log Questionnaire.
In this adapted questionnaire, the participant will be asked to classify the use of the arm in function of the quantity (0 - not used;1 - very rarely; 2 - rarely; 3 -half pre-stroke; 4- 3/4 pre-stroke; 5 - same as pre-stroke.) and quality (0 - not used.1 - very poor.2 - poor.3 - fair.4 - almost normal.5 - normal.) in the evaluated tasks.
|
User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
December 26, 2019
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
May 27, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
December 30, 2019
Last Update Submitted That Met QC Criteria
December 27, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0348/CIE/ 6_E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.