NCT01876030

Brief Summary

The investigators hypothesize that the gait pattern of following the utilization of a functional electrical stimulation device will be much improved when compared to the effect of regular gait re-education with ankle-foot-orthosis (AFO) fitting in patients in early stages following stroke.

Trial Health

55
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 2, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2013

Enrollment Period

4 years

First QC Date

May 2, 2013

Last Update Submit

May 2, 2016

Conditions

Dropped Foot

Keywords

Functional electrical stimulation (FES)Sub acute strokeGait analysis

Outcome Measures

Primary Outcomes (2)

  • Change in velocity of gait

    Measured in m/s and the change will be in %

    Baseline, 4 weeks and 12 week follwing baseline

  • Change in step length

    Measured in cm and the change will be in %

    Baseline, 4 and 12 weeks following baseline

Secondary Outcomes (3)

  • Gait symmetry

    Baseline, 4 and 12 weeks following baseline

  • Muscle activity patterns

    Baseline, 4 and 12 weeks following baseline

  • Functional assessment

    At baseline, 4 and 12 weeks following baseline

Study Arms (2)

FES

EXPERIMENTAL

All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the FES will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.

Device: FES

Conventional

NO INTERVENTION

Treated with regular gait re-education with or without AFO fitting. All subjects will receive a 15-30 minutes a day treatment for 5 days a week. When the subjects achieves the ability to walk with supervision, but with no physical assistance, safely and consistently during the physiotherapy sessions, then either the AFO will be provided to the subject to allow ongoing gait practice with the nursing staff in the ward environment. After discharge, the assistive device will be provided for home usage till the end of the research.

Interventions

FESDEVICE
Also known as: Mygait
FES

Eligibility Criteria

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

You may qualify if:

  • Sub-acute stroke patients suffering a first stroke with clinical presentation, according to the WHO definitions
  • Patients suffering from unilateral foot drop
  • Independent ambulation before the stroke
  • Cognitive and cooperative ability to follow simple instructions
  • Neurological condition severity mild to moderate (between 3 and 15, according to the National Institutes of Health Stroke Scale; NIHSS).
  • Ability to walk with or without a walking aid (cane, walker), with or without assistance. Functional Ambulation Classification (FAC) of at least 2
  • Independently capable to understand an informed consent form.

You may not qualify if:

  • Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
  • Orthopaedic injury to the paretic or non-paretic limbs
  • Motor disability due to neurological diagnosis, e.g. multiple sclerosis, cerebral palsy, spinal cord injury, and Parkinson
  • Peripheral injury of the peroneal nerve or sciatic nerve
  • Pregnant or nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Sigal Portnoy, PhD

CONTACT

0097225844492sigalp@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

June 12, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Last Updated

May 3, 2016

Record last verified: 2013-04

Locations

IL(1)