Robot-assisted gait training and assessment for neurological patients

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This protocol describes a framework, according to which a set of studies and<br /><br>experiments can be designed that each might have slightly different main<br /><br>endpoints. The feasibility of a control algorithm and robotic module will might<br /><br>be assessed based on its ability to provide the patient with the required<br /><br>support in a safe and comfortable way, its ability to bring about the desired<br /><br>changes in walking pattern in healthy subjects and patients, and its ability to<br /><br>encourage patients in self-generating muscle activity and its ability to reduce<br /><br>metabolic cost in healthy subjects and patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The measured muscle activity will be used to determine whether the control<br /><br>algorithm encourages patients in self generating muscle activity. The responses<br /><br>in the joint movements to the robotically applied forces will be used to derive<br /><br>the subject specific impairments. The measured metabolic rate will be used to<br /><br>determine the effect of new control algorithms on the energy cost. </p><br>