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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gait Profile Score (GPS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will be blinded to the patients´ allocation in terms of intervention
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Gait Profile Score (GPS)
时间窗: 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
时间窗: At baseline and after completion of the 4 week intervention to assess change.
Assesses walking endurance in meters walked
Ankle Sagittal range (degrees)
时间窗: 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
时间窗: 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
时间窗: 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
Step length
时间窗: 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
次要结局
- The Montreal Cognitive Assessment (MoCa)(At baseline and after completion of the 4 week intervention to assess change.)
- Fugl-Meyer score (FMA-LE)(At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.)
- Modified Ashworth scale 0-5(At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.)
- Medical Research Council scale(At baseline and after completion of the 4 week intervention)
- The 10 meter walk test(At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.)
- Indirect Calorimetries(At baseline and after the intervention to assess change)
- Electromyography (EMG)(At baseline and after completion of the 4 week intervention to assess change.)
- Eq-5d-5l(At baseline and after completion of the 4 week intervention to assess change.)
- Walking impact scale (MSWS-12 S)(At baseline and after completion of the 4 week intervention to assess change.)
- Neuroflexor(At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.)
- Rated Perceived Exertion (RPE) Scale(At baseline, weekly during the intervention and after the intervention to assess change)
- Time accomplished during each training session(Daily during the intervention)
- 6 minutes walk test(At baseline, weekly during the intervention and after the intervention to assess change)
- 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.)
- The Balance evaluation systems test (BEST-test)(At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.)
- The Functional Ambulation Categories (FAC)(At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.)
- Falls Efficacy Scale (FES-S)(At baseline and after completion of the 4 week intervention to assess change.)
- Barthel Index(At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.)
- A study specific questionnaire - a questionnaire for the experimental group(After completion of the 4 week intervention)
- Distance accomplished during each training session(Daily during the intervention)
研究者
Susanne Palmcrantz
PhD, Reg Physiotherapist
Danderyd Hospital