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Clinical Trials/NL-OMON35943
NL-OMON35943
Completed
Not Applicable

Collection of thigh acceleration data to evaluate the Neurostep® gait event detection performance in subjects with foot drop secondary to an upper motor neuron lesion - Collection of thigh acceleration data for gait event detection

eurostream Technologies, G.P.0 sites10 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
traumatic brain and spinal cord injuries
Sponsor
eurostream Technologies, G.P.
Enrollment
10
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
eurostream Technologies, G.P.

Eligibility Criteria

Inclusion Criteria

  • 1\. Male or female, \>\= 18 years of age;
  • 2\. Have a unilateral and persisting weakness or lack of control in ankle control during gait secondary to a chronic upper motor neuron lesion (\>6 months ago);
  • 3\. The subject\*s gait impairment involves a clinically significant deficit in ankle control during gait, including a foot drop;
  • 4\. Be able to stand and walk at least 10 meters without an AFO (other assistive devices are allowed if needed), while requiring no more than close supervision;
  • 5\. Subject must have an average, self\-selected, comfortable walking speed lower than 1\.0 meter per second;
  • 6\. Have a passive ankle range of motion that allows dorsiflexion to neutral (be able to stand upright with both heels touching the floor while hip and knee are in the neutral position) and 20 degrees in plantar flexion;
  • 7\. Subject is able to provide informed consent;
  • 8\. Subject must be willing and able to follow all study procedures including attendance at clinics for scheduled study visits.;At least three subjects must be recruited with the following additional criteria:
  • 9\. A plantar flexion insufficiency (i.e., lack of control or weakness), defined as the inability to lift the heel (at least 2 cm) during single\-leg stance while standing on the affected leg;
  • 10\. Subject must have an average self\-selected comfortable walking speed lower than 0\.5 meter per second on average.

Exclusion Criteria

  • 1\. Women who are pregnant;
  • 2\. The subject has uncompensated hemi\-neglect or pushers syndrome;
  • 3\. Subject has a bilateral gait impairment or bilateral impairment in ankle control;
  • 4\. Subjects with excessive spasticity: with a modified Ashworth scale score of more than 3;
  • 5\. Subject exhibits other gait disorders that would impact his/her gait ability (e.g., hip impairment, significant degenerative joint disease at the hip/knee).

Outcomes

Primary Outcomes

Not specified

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