Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945395
• Other study ID #: FES-study
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: Danderyd Hospital
• Contact: Susanne Palmcrantz, PhD
• Phone: 004681235000
• Email: susanne.palmcrantz[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Hemiplegia
• Mobility Limitation
• Stroke

Intervention

Device:
• 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

Locations

Country	Name	City	State
Sweden	Department of Rehabilitation Medicine, Danderyd Hospital	Danderyd	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	KTH Royal Institute of Technology

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait 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	At baseline and after completion of the 4 week intervention to assess change.
Primary	Ankle Sagittal range (degrees)	Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)	At baseline and after completion of the 4 week intervention to assess change.
Primary	Ankle Positive work	Assesses the force at the ankle joint (J/kg) detected in gait laboratory	At baseline and after completion of the 4 week intervention to assess change.
Primary	Step length	Step length will be assessed in the gait laboratory with 3D gait analyses	At baseline and after completion of the 4 week intervention to assess change.
Primary	6 minutes walk test	Assesses walking endurance in meters walked	At baseline and after completion of the 4 week intervention to assess change.
Primary	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.	At baseline and after completion of the 4 week intervention to assess change.
Secondary	The Montreal Cognitive Assessment (MoCa)	Assesses mental function (0p max impairment summed up to 30p no detected impairment)	At baseline and after completion of the 4 week intervention to assess change.
Secondary	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)	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	Neuroflexor	Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)	At baseline, weekly during the intervention, and after completion of the 4 week intervention to assess change.
Secondary	Modified Ashworth scale 0-5	Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)	At baseline, weekly during the intervention and after completion of the 4 week intervention, to assess change.
Secondary	Passive range of motion in the lower extremity	Clinical assessment of range of motion with a goniometer	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	Medical Research Council scale	Assesses muscle strength on a 6 point scale/muscle (0p max impairment summed up to 5p no impairment/muscle)	At baseline and after completion of the 4 week intervention
Secondary	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)	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	The 10 meter walk test	Assesses gait speed	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	6 minutes walk test	Assesses walking endurance in meters walked	At baseline, weekly during the intervention and after the intervention to assess change
Secondary	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.	At baseline, weekly during the intervention and after the intervention to assess change
Secondary	Indirect Calorimetries	To assess energy expenditure based on respiratory gas exchange. Will be performed during the 6 minutes walk test.	At baseline and after the intervention to assess change
Secondary	Electromyography (EMG)	EMG is used to measure muscle activation patterns during gait.	At baseline and after completion of the 4 week intervention to assess change.
Secondary	Walking impact scale (MSWS-12 S)	Assesses self-perceived limitations in walking (12p no impairments summed up to 60p max impairment)	At baseline and after completion of the 4 week intervention to assess change.
Secondary	The Functional Ambulation Categories (FAC)	Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	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	At baseline and after completion of the 4 week intervention to assess change.
Secondary	Barthel Index	Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p	At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Secondary	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).	At baseline and after completion of the 4 week intervention to assess change.
Secondary	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.	After completion of the 4 week intervention
Secondary	Distance accomplished during each training session	The FES-system will collect this data to assess training intensity	Daily during the intervention
Secondary	Time accomplished during each training session	The FES-system will collect this data to assess training intensity	Daily during the intervention