traumatic brain and spinal cord injuries drop foot lack of ankle dorsiflexion control secondary to upper motor neuron lesion
Conditions
Interventions
None listed
Sponsors
Neurostream Technologies, G.P.
Eligibility
Age
18 Years to 99 Years
Inclusion 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. (Note: At least three of the subjects must have criterion 9 and three of the subjects must have criterion 10 but it is not required neither prohibited that they meet criteria 9 and 10 simultaneously).
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameter Thigh acceleration data versus external gait event references (foot contact/foot OFF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters 1) Level walking detection performance (with thigh acceleration data) in subjects, representative of the Neurostep® target population. 2) Detection performance (with thigh acceleration data) in more complex (than level walking) activities of daily living . 3) The impact of activating dorsiflexors* stimulation on the configuration process and detection performance. This parameter is optional and dependent on the recruitment of subjects already using and trained with other FES systems (e.g., ActiGait, Walkaid, Odstock, STIMuSTEP*, Bioness*). | — |
Countries
Netherlands
Outcome results
None listed