Functional Eletrical Stimulation in Post Stroke Patients

Stroke Clinical Trial

— FES-ABLE  

Official title:

Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967613
• Other study ID #: 0348/CIE/ 6_E
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: December 2019
• Source: School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 26, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Functional eletrical stimulation
Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks

Locations

Country	Name	City	State
Portugal	Center for Rehabilitation Research	Porto

Sponsors (4)

Lead Sponsor	Collaborator
School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)	Center for Rehabilitation Research (CIR), Fundación General CSIC, Tecnalia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic metrics change	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	User satisfaction	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