Effect of Functional Electric Stimulation for Recovery of Dorsiflexion After Stroke

NCT04945395 | Unknown

• 1 other identifier: FES-study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Ambulation Difficulty; Hemiplegia

Keywords

Rehabilitation; Functional electrical stimulation; Walking; Stroke

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 6 minutes walk test

  Assesses walking endurance in meters walked

  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.

  At baseline and after completion of the 4 week intervention to assess change.

Secondary Outcomes (20)

• 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.

• Neuroflexor

  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.

• 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.

Study Arms (2)

FES and conventional training

EXPERIMENTAL

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.

Device: FES and Conventional training

AFO and Conventional training only

ACTIVE COMPARATOR

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.

Device: AFO and Conventional training

Interventions

FES and Conventional training DEVICE

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.

FES and conventional training

AFO and Conventional training DEVICE

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

AFO and Conventional training only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danderyd Hospital: lead
• KTH Royal Institute of Technology: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, 18288, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke; Mobility Limitation; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations

Study Officials

• Susanne Palmcrantz, PhD

  Dep of Clinical Sciences, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Palmcrantz, PhD

CONTACT

004681235000; susanne.palmcrantz@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to the patients´ allocation in terms of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Reg Physiotherapist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 30, 2021
• Study Start: August 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-01

Locations

SE (1)