Clinical trial NCT04945395: Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
Official title: The Effect of Using Functional Electric Stimulation for the Recovery of Dorsiflexion During Rehabilitation of Gait Function, in the Subacute Phase After Stroke- a Randomized Controlled Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Ambulation Difficulty
Hemiplegia
Keywords: Rehabilitation
Functional electrical stimulation
Walking
Stroke
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: KTH Royal Institute of Technology
First posted: 2021-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Eligible will be patients who have suffered a stroke, verified by CT or MRI examination and are admitted to inpatient care at the University Department of Rehabilitation Medicine Stockholm, Danderyd Hospital in Sweden where approximately 220 patients are treated annually (Stroke (50%)).

Inclusion criteria:

* 20 participants with hemiplegia
* 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:

* 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.

Primary outcomes:
measure: Gait Profile Score (GPS)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Ankle Sagittal range (degrees)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Ankle Positive work
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Step length
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: 6 minutes walk test
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Rated Perceived Exertion (RPE) Scale
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
Secondary outcomes:
measure: The Montreal Cognitive Assessment (MoCa)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Fugl-Meyer score (FMA-LE)
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: Neuroflexor
timeFrame: At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.
measure: Modified Ashworth scale 0-5
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.
measure: Passive range of motion in the lower extremity
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: Medical Research Council scale
timeFrame: At baseline and after completion of the 4 week intervention
measure: The Balance evaluation systems test (BEST-test)
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: The 10 meter walk test
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: 6 minutes walk test
timeFrame: At baseline, weekly during the intervention and after the intervention to assess change
measure: Rated Perceived Exertion (RPE) Scale
timeFrame: At baseline, weekly during the intervention and after the intervention to assess change
measure: Indirect Calorimetries
timeFrame: At baseline and after the intervention to assess change
measure: Electromyography (EMG)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Walking impact scale (MSWS-12 S)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: The Functional Ambulation Categories (FAC)
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: Falls Efficacy Scale (FES-S)
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: Barthel Index
timeFrame: At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
measure: Eq-5d-5l
timeFrame: At baseline and after completion of the 4 week intervention to assess change.
measure: A study specific questionnaire - a questionnaire for the experimental group
timeFrame: After completion of the 4 week intervention
measure: Distance accomplished during each training session
timeFrame: Daily during the intervention
measure: Time accomplished during each training session
timeFrame: Daily during the intervention
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
affiliation: Dep of Clinical Sciences, Karolinska Institutet
name: Susanne Palmcrantz, PhD
role: PRINCIPAL_INVESTIGATOR
References: