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Clinical Trials/NCT01876030
NCT01876030
Unknown
Not Applicable

Comparison of Different Treatment Methods for Gait Rehabilitation of Sub-Acute Post Stroke Patients With Dropped Foot

Hadassah Medical Organization1 site in 1 country40 target enrollmentJune 2013
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ConditionsDropped Foot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dropped Foot
Sponsor
Hadassah Medical Organization
Enrollment
40
Locations
1
Primary Endpoint
Change in velocity of gait
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Change in velocity of gait

Time Frame: Baseline, 4 weeks and 12 week follwing baseline

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

Change in step length

Time Frame: Baseline, 4 and 12 weeks following baseline

Measured in cm and the change will be in %

Secondary Outcomes

  • Gait symmetry(Baseline, 4 and 12 weeks following baseline)
  • Functional assessment(At baseline, 4 and 12 weeks following baseline)
  • Muscle activity patterns(Baseline, 4 and 12 weeks following baseline)

Study Sites (1)

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