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Robotic support in gait training for neurological patients

Completed
Conditions
cerebrovascular accident / spinal cord injury
Myelopathy
Stroke
10007963
Registration Number
NL-OMON44012
Lead Sponsor
niversiteit Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

In general the inclusion criteria 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

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
NameTimeMethod
<p>The feasibility of a control algorithm will be assessed based on its ability to<br /><br>provide the patient with the required support in a safe and comfortable way,<br /><br>its ability to bring about the desired walking pattern </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The measured muscle activity will be used to determine whether the control<br /><br>algorithm encourages patients in self generating muscle activity.<br /><br>The responses in the joint movements to the robotically applied forces will be<br /><br>used to derive the subject specific impairments. </p><br>
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