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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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.
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
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, Sweden
RECRUITINGGait Profile Score (GPS)
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
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Ankle Sagittal range (degrees)
Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Ankle Positive work
Assesses the force at the ankle joint (J/kg) detected in gait laboratory
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Step length
Step length will be assessed in the gait laboratory with 3D gait analyses
Time frame: At baseline and after completion of the 4 week intervention to assess change.
6 minutes walk test
Assesses walking endurance in meters walked
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Rated Perceived Exertion (RPE) Scale
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.
Time frame: At baseline and after completion of the 4 week intervention to assess change.
The Montreal Cognitive Assessment (MoCa)
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Fugl-Meyer score (FMA-LE)
Assesses sensory and movement related functions in the lower extremity (0p max impairment summed up to 86p max no detected impairment)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Time frame: At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.
Modified Ashworth scale 0-5
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.
Passive range of motion in the lower extremity
Clinical assessment of range of motion with a goniometer
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Medical Research Council scale
Assesses muscle strength on a 6 point scale/muscle (0p max impairment summed up to 5p no impairment/muscle)
Time frame: At baseline and after completion of the 4 week intervention
The Balance evaluation systems test (BEST-test)
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)
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
The 10 meter walk test
Assesses gait speed
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
6 minutes walk test
Assesses walking endurance in meters walked
Time frame: At baseline, weekly during the intervention and after the intervention to assess change
Rated Perceived Exertion (RPE) Scale
Ratings (min 6, max 20) according to the RPE scale are made at the end of the 6 minutes walk test.
Time frame: At baseline, weekly during the intervention and after the intervention to assess change
Indirect Calorimetries
To assess energy expenditure based on respiratory gas exchange. Will be performed during the 6 minutes walk test.
Time frame: At baseline and after the intervention to assess change
Electromyography (EMG)
EMG is used to measure muscle activation patterns during gait.
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Walking impact scale (MSWS-12 S)
Assesses self-perceived limitations in walking (12p no impairments summed up to 60p max impairment)
Time frame: At baseline and after completion of the 4 week intervention to assess change.
The Functional Ambulation Categories (FAC)
Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Falls Efficacy Scale (FES-S)
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
Time frame: At baseline and after completion of the 4 week intervention to assess change.
Barthel Index
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
Time frame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Eq-5d-5l
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).
Time frame: At baseline and after completion of the 4 week intervention to assess change.
A study specific questionnaire - a questionnaire for the experimental group
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.
Time frame: After completion of the 4 week intervention
Distance accomplished during each training session
The FES-system will collect this data to assess training intensity
Time frame: Daily during the intervention
Time accomplished during each training session
The FES-system will collect this data to assess training intensity
Time frame: Daily during the intervention
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