Primary objective: Determine for different control algorithms whether the algorithm is effective in providing the patient with the required support and bringing about the desired changes in the walking patternSecondary Objective(s): - Determine…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility of a control algorithm will 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 walking pattern
Secondary outcome
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.
Background summary
Task specific and intensive training of repetitive active movements results in
the largest functional improvements in the rehabilitation of stroke patients
and spinal cord injury patients. Providing this kind of therapy for gait
training puts a high physical burden on therapists. For instance, in gait
training on a treadmill with partial bodyweight usually 2 therapists are needed
to assist the patient in walking. In the past years, a new robot device, LOPES
II, has been developed which can provide neurological patients with the
necessary support in gait training. In LOPES II, the amount of support during
walking can be adjusted, varying from high (robot-in-charge mode) to zero
(patient-in-charge mode). The challenge is to apply as much support as the
patient needs to perform the selected exercise. The support should allow the
patient to walk and still encourage him/her to provide an active contribution.
Different algorithms have been proposed but they are not yet tested for their
feasibility in severely affected neurological patients. Additionally to be able
to tailor the support to the patient*s needs, the patient impairments need to
be characterized. The response of patients to the robotic forces applied during
walking can be used to derive a measure of the impairments that limit the
walking ability
Study objective
Primary objective:
Determine for different control algorithms whether the algorithm is effective
in providing the patient with the required support and bringing about the
desired changes in the walking pattern
Secondary Objective(s):
- Determine whether the different control algorithms result in changes of the
self generated activity of the patient.
- Quantify the impairments that limit walking in neurological patients using
LOPES II.
Study design
This study is designed as an observational study
Study burden and risks
Subjects will participate in at least one session and maximally in 5 sessions.
In the first session the subject will be asked to walk with LOPES II maximally
4 trials of 3 minutes. The trials differ in the used algorithm to control LOPES
II and/or the magnitude of the provided support. Depending on the patient*s
physical condition and the physical effort (monitored by using the heart rate,
the Borg Scale and the opinion of the present physical therapist) in the first
session, the amount of trials will be slowly upgraded to maximal 10 trials of 3
minutes in subsequent sessions. Between the trials subjects will receive time
to rest. The LOPES II device was extensively tested for safety. During all test
the implemented safety measures will assure that the exerted torques and the
performed movements are within safe limits.
De Horst 2
Enschede 7522LW
NL
De Horst 2
Enschede 7522LW
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL32841.044.10 |