Back to resultsEffect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
Primary Purpose
Stroke, Ambulation Difficulty, Hemiplegia
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
FES and Conventional training
AFO and Conventional training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Functional electrical stimulation, Walking, Stroke
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.
Sites / Locations
- Department of Rehabilitation Medicine, Danderyd HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FES and conventional training
AFO and Conventional training only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Ankle Sagittal range (degrees)
Assesses range of motion in the ankle (plantarflexion from 0-50 degrees, dorsiflexion from 0-20 degrees)
Ankle Positive work
Assesses the force at the ankle joint (J/kg) detected in gait laboratory
Step length
Step length will be assessed in the gait laboratory with 3D gait analyses
6 minutes walk test
Assesses walking endurance in meters walked
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.
Secondary Outcome Measures
The Montreal Cognitive Assessment (MoCa)
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
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)
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Modified Ashworth scale 0-5
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Passive range of motion in the lower extremity
Clinical assessment of range of motion with a goniometer
Medical Research Council scale
Assesses muscle strength on a 6 point scale/muscle (0p max impairment summed up to 5p no impairment/muscle)
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)
The 10 meter walk test
Assesses gait speed
6 minutes walk test
Assesses walking endurance in meters walked
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.
Indirect Calorimetries
To assess energy expenditure based on respiratory gas exchange. Will be performed during the 6 minutes walk test.
Electromyography (EMG)
EMG is used to measure muscle activation patterns during gait.
Walking impact scale (MSWS-12 S)
Assesses self-perceived limitations in walking (12p no impairments summed up to 60p max impairment)
The Functional Ambulation Categories (FAC)
Assesses independence in walking (0p nonfunctional, 5p independent) Total score 0-5p
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
Barthel Index
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
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).
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.
Distance accomplished during each training session
The FES-system will collect this data to assess training intensity
Time accomplished during each training session
The FES-system will collect this data to assess training intensity
Full Information
NCT ID
NCT04945395
First Posted
June 3, 2021
Last Updated
February 7, 2023
Sponsor
Danderyd Hospital
Collaborators
KTH Royal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04945395
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
KTH Royal Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ambulation Difficulty, Hemiplegia
Keywords
Rehabilitation, Functional electrical stimulation, Walking, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to the patients´ allocation in terms of intervention
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FES and conventional training
Arm Type
Experimental
Arm Description
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.
Arm Title
AFO and Conventional training only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FES and Conventional training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AFO and Conventional training
Intervention Description
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
Primary Outcome Measure Information:
Title
Gait Profile Score (GPS)
Description
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.
Title
Ankle Sagittal range (degrees)
Description
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.
Title
Ankle Positive work
Description
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.
Title
Step length
Description
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.
Title
6 minutes walk test
Description
Assesses walking endurance in meters walked
Time Frame
At baseline and after completion of the 4 week intervention to assess change.
Title
Rated Perceived Exertion (RPE) Scale
Description
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.
Secondary Outcome Measure Information:
Title
The Montreal Cognitive Assessment (MoCa)
Description
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.
Title
Fugl-Meyer score (FMA-LE)
Description
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.
Title
Neuroflexor
Description
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.
Title
Modified Ashworth scale 0-5
Description
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.
Title
Passive range of motion in the lower extremity
Description
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.
Title
Medical Research Council scale
Description
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
Title
The Balance evaluation systems test (BEST-test)
Description
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.
Title
The 10 meter walk test
Description
Assesses gait speed
Time Frame
At baseline, weekly during the intervention and after completion of the 4 week intervention to assess change.
Title
6 minutes walk test
Description
Assesses walking endurance in meters walked
Time Frame
At baseline, weekly during the intervention and after the intervention to assess change
Title
Rated Perceived Exertion (RPE) Scale
Description
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
Title
Indirect Calorimetries
Description
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
Title
Electromyography (EMG)
Description
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.
Title
Walking impact scale (MSWS-12 S)
Description
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.
Title
The Functional Ambulation Categories (FAC)
Description
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.
Title
Falls Efficacy Scale (FES-S)
Description
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.
Title
Barthel Index
Description
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.
Title
Eq-5d-5l
Description
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.
Title
A study specific questionnaire - a questionnaire for the experimental group
Description
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
Title
Distance accomplished during each training session
Description
The FES-system will collect this data to assess training intensity
Time Frame
Daily during the intervention
Title
Time accomplished during each training session
Description
The FES-system will collect this data to assess training intensity
Time Frame
Daily during the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Palmcrantz, PhD
Phone
004681235000
Email
susanne.palmcrantz@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Palmcrantz, PhD
Organizational Affiliation
Dep of Clinical Sciences, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Danderyd Hospital
City
Danderyd
State/Province
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Palmcrantz, PhD
Email
susanne.palmcrantz@ki.se
12. IPD Sharing Statement
Learn more about this trial
Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke
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