cerebrovascular accident / spinal cord injury myelopathy Stroke
Conditions
Interventions
Sponsors
Universiteit Twente
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In general the inclusion criteria for healthy subjects and SCI/stroke subjects are: -age > 18 years - a stable medical condition - a physical condition which allows for 3 minutes of supported walking - have sufficient cognitive abilities (Mini-Mental State Examination * 22) ;Specifically inclusion criteria for spinal cord injury patients are: - a first ever SCI - time since injury > 6 months - complete or incomplete lesion (AIS A,B, C or D) - injury to the spinal cord from below C6, on at least one side of the body - able to sit unsupported (to sit upright without using the hands or an external support) ;Stroke patients are explicitly included in the study if they: - are diagnosed with a hemiparesis as the result of a stroke - have had the stroke > 6 months ago - score 1 to 4 on the functional ambulation classification - have sufficient communication abilities (Utrechtse Communicatie Onderzoek * 3)
Exclusion criteria
Exclusion criteria: Healthy subjects, spinal cord injury patients and stroke patients are excluded if they: - have current orthopaedic problems - other neurological diseases - have a history of cardiac conditions that interfere with physical load - had no independent ambulation prior to SCI or stroke, - have contraindication for lower extremity weight bearing (chronic joint pain, fracture) - inappropriate or unsafe fit of the robotic trainer due to the participant*s body size (bodyweight > 100 kg) and/ or joint contractures. - have spin-stabilizing devices for whom their treating surgeon contraindicates gait - have pressure sore stage 2 or higher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This protocol describes a framework, according to which a set of studies and experiments can be designed that each might have slightly different main endpoints. The feasibility of a control algorithm and robotic module will might be assessed based on its ability to provide the patient with the required support in a safe and comfortable way, its ability to bring about the desired changes in walking pattern in healthy subjects and patients, and its ability to encourage patients in self-generating muscle activity and its ability to reduce metabolic cost in healthy subjects and patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured muscle activity will be used to determine whether the control algorithm encourages patients in self generating muscle activity. The responses in the joint movements to the robotically applied forces will be used to derive the subject specific impairments. The measured metabolic rate will be used to determine the effect of new control algorithms on the energy cost. | — |
Countries
The Netherlands
Outcome results
None listed