NCT04381546

Brief Summary

The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 16, 2018

Last Update Submit

May 5, 2020

Conditions

HemiplegiaGait, HemiplegicGait, UnsteadyRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Assymetry of stance phase

    symmetry ratio of stance duration between paretic and non-paretic limbs

    24 hours

  • Assymetry of weight support in stance phase

    percentage of weight supported during stance phase relatively to the total weight

    24 hours

Secondary Outcomes (4)

  • Comfortable walking speed

    24 hours

  • Cadence

    24 hours

  • Physiological Cost Index (PCI)

    24 hours

  • Borg score of the exercise intensity

    24 hours

Study Arms (1)

FES in patients with hemiplegia

EXPERIMENTAL

Patients will be equipped with 5 inertial measurement units. Two wireless bluetooth pressure insoles will be connected to the Raspberry. Electrical stimulation will be delivered via a wireless stimulator to the quadriceps and hamstrings via surface electrodes. Insoles will be used to online analyze Paretic Foot Support to discriminate between stance and swing phases. Stimulation will also be delivered just before initial contact at the end of swing phase. In stance phase, stimulation will be triggered either to quadriceps or hamstrings, depending on the paretic knee angle estimation relatively to the knee angle setpoint defined by the practitioner as the optimal flexion during stance phase (around 5°).

Other: Functional Electrical Stimulation FES

Interventions

Functional Electrical Stimulation FESOTHER

Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb in patients with hemiplegia. It is based on the real-time estimation of the knee angle and support phase during gait.

FES in patients with hemiplegia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years
  • Cerebral injury or stroke
  • Interval time since the onset of the neurological event: min 8 weeks (in case of an acute cerebral damage) or at a any time in case of a chronic affection
  • Surface electrical stimulation of quadriceps and hamstrings possible
  • Free range of motion in lower limbs
  • Ankle-foot orthosis, dynamic or static
  • Limited perimeter distance \< 50 meters with or without walking technical aids

You may not qualify if:

  • Knee-Ankle-Foot orthosis is required
  • Body mass index \> or = 30
  • Thrombophlebitis
  • Muscular pathology
  • Unstable Cardio-Vascular pathology
  • Lower limb prosthesis
  • Unstable seizures
  • Orthostatic hypotension
  • Recent fracture in lower limbs (\<12 months)
  • Pacemaker
  • Pregnancy
  • Betablockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie

Menucourt, 95180, France

Location

MeSH Terms

Conditions

HemiplegiaGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charles Fattal, MD, PhD

    Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
FES-based control of knee joint to reduce stance phase asymmetry during gait in patients with post-stroke hemiplegia
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 11, 2020

Study Start

April 26, 2018

Primary Completion

April 30, 2019

Study Completion

June 30, 2019

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

FR(1)