Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
- Conditions
- StrokeAmbulation DifficultyHemiplegia
- Interventions
- Device: AFO and Conventional trainingDevice: FES and Conventional training
- Registration Number
- NCT04945395
- Lead Sponsor
- Danderyd Hospital
- Brief Summary
The purpose of this project is to investigate the effect of functional electrical stimulation (FES) for recovery of dorsiflexion after stroke. It will be led from the University Department of Rehabilitation Medicine at Danderyd Hospital (RMDS) in collaboration with the MoveAbility Lab at KTH Royal Institute of Technology. Patients referred to RMDS for inpatient rehabilitation early after hemiparetic stroke will be included.
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.
- Detailed Description
Participants will be included and allocated to either experimental group with training incorporating the FES-system and conventional training or to control group with conventional training only. Data will be collected before and after the intervention at RMDS and at the MoveAbility Lab. Physical tests and self-scored questionnaires of self-perceived aspects of functioning and disability will be performed at RMDS and gait analysis with 3D cameras and assessment of muscle function with EMG will be performed at the MoveAbilityLab. In addition, a short assessment of body function and activity will be performed weekly at RMDS by the therapist responsible for the rehabilitation intervention.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- Contracture severely restricting gait movements at any lower limb joint
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AFO and Conventional training only AFO and Conventional training 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. FES and conventional training 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.
- Primary Outcome Measures
Name Time Method Step length At baseline and after completion of the 4 week intervention to assess change. Step length will be assessed in the gait laboratory with 3D gait analyses
Gait Profile Score (GPS) At baseline and after completion of the 4 week intervention to assess change. GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. The GPS can be decomposed to provide the Gait Variable Score (GVS) (an index that measures single gait variable deviation), for nine key relevant kinematic variables. A larger GPS indicates greater deviation from normal gait
6 minutes walk test At baseline and after completion of the 4 week intervention to assess change. Assesses walking endurance in meters walked
Ankle Sagittal range (degrees) At baseline and after completion of the 4 week intervention to assess change. Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)
Rated Perceived Exertion (RPE) Scale At baseline and after completion of the 4 week intervention to assess change. Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test. A higher score indicates a higher degree of perceived exertion.
Ankle Positive work At baseline and after completion of the 4 week intervention to assess change. Assesses the force at the ankle joint (J/kg) detected in gait laboratory
- Secondary Outcome Measures
Name Time Method The Montreal Cognitive Assessment (MoCa) At baseline and after completion of the 4 week intervention to assess change. Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Electromyography (EMG) At baseline and after completion of the 4 week intervention to assess change. EMG is used to measure muscle activation patterns during gait.
Fugl-Meyer score (FMA-LE) At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
Modified Ashworth scale 0-5 At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change. Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Medical Research Council scale At baseline and after completion of the 4 week intervention Assesses muscle strength on a 6 point scale/muscle (0p max impairment summed up to 5p no impairment/muscle)
The 10 meter walk test At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Assesses gait speed
Indirect Calorimetries At baseline and after the intervention to assess change To assess energy expenditure based on respiratory gas exchange. Will be performed during the 6 minutes walk test.
Eq-5d-5l At baseline and after completion of the 4 week intervention to assess change. Assesses self perceived health related quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and on a vertical visual analogue scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (1 = no problem, 5 = extreme problems). The vertical visual analogue scale is graded from 0-100 (0 = the worst health you can imagine 100 = the best health you can imagine).
Walking impact scale (MSWS-12 S) At baseline and after completion of the 4 week intervention to assess change. Assesses self-perceived limitations in walking (12p no impairments summed up to 60p max impairment)
Neuroflexor At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change. Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Rated Perceived Exertion (RPE) Scale At baseline, weekly during the intervention and after the intervention to assess change Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test.
Time accomplished during each training session Daily during the intervention The FES-system will collect this data to assess training intensity
6 minutes walk test At baseline, weekly during the intervention and after the intervention to assess change Assesses walking endurance in meters walked
Passive range of motion in the lower extremity At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Clinical assessment of range of motion with a goniometer
The Balance evaluation systems test (BEST-test) At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Assesses postural control, incorporating bio-mechanical systems, limits of stability, anticipatory postural adjustment, automatic postural responses, sensory orientation, stability in gait (0p max impairment summed up to 108p no impairment)
The Functional Ambulation Categories (FAC) At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
Falls Efficacy Scale (FES-S) At baseline and after completion of the 4 week intervention to assess change. Assesses self perceived balance in every day life activities rated on a 11 point scale (0p not safe at all 10p completely safe). Total score: 0- 130 p
Barthel Index At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change. Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
A study specific questionnaire - a questionnaire for the experimental group After completion of the 4 week intervention A questionnaire with 11 questions assessing the patients experience of participating in the study and the use of the FES-system. The patient rates on a 10 graded scale (0 = not at all, 10 = very much): the information given about the study, the experience, usability and comfort of using the system, eventual pain, skin problems and technical problems with the system and experience of eventual benefits from having used the system.
Distance accomplished during each training session Daily during the intervention The FES-system will collect this data to assess training intensity
Trial Locations
- Locations (1)
Department of Rehabilitation Medicine, Danderyd Hospital
🇸🇪Danderyd, Stockholm, Sweden