Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
NCT ID: NCT04945395
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-08-15
2024-02-29
Brief Summary
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The overall aim is to explore how 4 weeks of training incorporating the FES-system (L300 Go System ® Bioness, Ottobock) effect function of the lower extremity, gait function and mobility when compared to conventional training only, in the subacute stage after stroke.
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Detailed Description
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The experimental group will wear the FES-system L300 Go at all times when the patient is taking part in rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. The settings will be adjusted by the employee from the technical company and/or the physiotherapist continuously during the intervention if needed. The system will register the distance and time accomplished during each session. Due to risk of skin irritation, if the system is overused in the beginning the experimental group will have access to an ankle-foot-orthosis too.
The control group will wear an ankle-foot-orthosis (AFO) and receive conventional training. The control group will wear a FES-system too, to record the distance and time accomplished during each session, but the system will not be active for stimulation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FES and conventional training
The experimental group will wear the Functional electrical stimulation system L3100 Go for dorsiflexion of the ankle during conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
FES and Conventional training
The experimental group will be fitted with the Functional electrical stimulation system L300 Go to be used during 4 weeks of inpatient rehabilitation in the subacute phase after hemiplegic stroke. Settings will be adjusted continuously to enhance dorsiflexion of the affected foot during walking and mobility training.
AFO and Conventional training only
The control group will wear an ankle-foot-orthosis (AFO) to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist.
AFO and Conventional training
The control group will be fitted with an ankle-foot-orthosis (AFO) according to clinical practice to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions during 4 weeks of inpatient rehabilitation including walking and mobility training in the subacute phase after hemiplegic stroke
Interventions
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FES and Conventional training
The experimental group will be fitted with the Functional electrical stimulation system L300 Go to be used during 4 weeks of inpatient rehabilitation in the subacute phase after hemiplegic stroke. Settings will be adjusted continuously to enhance dorsiflexion of the affected foot during walking and mobility training.
AFO and Conventional training
The control group will be fitted with an ankle-foot-orthosis (AFO) according to clinical practice to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions during 4 weeks of inpatient rehabilitation including walking and mobility training in the subacute phase after hemiplegic stroke
Eligibility Criteria
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Inclusion Criteria
* Dependence in ambulation (0- 4 according to the Functional Ambulation Categories)
* \>= 50 points on the Trunc Control Test.
* Impaired dorsiflexion manifested as impaired voluntarily dorsiflex and to hold the ankle in a dorsiflexed position while sitting and for ambulatory participants: during swing phase and heel strike while walking as demonstrated by visual inspection during gait analysis performed by the physiotherapist.
* Recommended to be fitted with an ankle-foot orthosis (AFO) by an experienced physiotherapist.
* Able to understand study information and to give informed consent.
Exclusion Criteria
* Cardiovascular or other somatic condition incompatible with intensive gait training
* Notifiable infectious disease, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria (ESBL)). - Not able to participate in the rehabilitation intervention due to behavioral disorder or psychiatric disease.
* The FES-system L300 Go ® should not be used if a the patient has a pacemaker, defibrillator or any electrical implant, a metallic implant in the affected leg, a cancerous lesion in the affected leg, a fracture or dislocation in the affected leg or if the affected leg is swollen, infected, or has inflamed areas or skin eruptions, such as phlebitis, thrombophlebitis, and varicose veins in the affected leg or if the patient is pregnant.
18 Years
65 Years
ALL
No
Sponsors
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KTH Royal Institute of Technology
OTHER
Danderyd Hospital
OTHER
Responsible Party
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Susanne Palmcrantz
PhD, Reg Physiotherapist
Principal Investigators
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Susanne Palmcrantz, PhD
Role: PRINCIPAL_INVESTIGATOR
Dep of Clinical Sciences, Karolinska Institutet
Locations
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Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FES-study
Identifier Type: -
Identifier Source: org_study_id
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