Primary Objective: To establish the effect of asymmetrical guidance provided by the Lokomat exoskeleton on levels of muscle activity in persons with post stroke hemiparesis. Secondary Objective(s): (i) To establish if the abovementioned effects (see…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amplitude of muscle activity in µvolts.
Secondary outcome
D.N.A.
Background summary
Research on bi-pedal pedaling has shown that movements of the ipsilateral leg
give rise to structured activity of muscles in the contralateral, stationary
leg. This shows that during cyclical leg movements, activity of the legs is
coupled. Apparently, the legs *listen* to each other, so that activity in one
leg can be used to affect activity in the other. To establish if during
walking, activity in one leg can be manipulated by letting the contralateral
leg *work harder* (of less hard), the Lokomat can be used. The Lokomat is a
robotic device, consisting of an actuated gait orthosis with integrated
computer-controlled linear actuators at each hip and knee joint, a body weight
support system, and a treadmill. The Lokomat allows the level of movement
support (so-called *guidance*) to be set independently for each leg. This makes
it possible to systematically vary the contribution of the individual legs to
the production of gait. By measuring muscle activity under these conditions, it
can be determined if *harder work* by one leg facilitates activity in the
other. If the results provide evidence for this idea, future training protocols
may exploit these properties and stimulate activity in the paretic leg by
manipulating activity in the other, (non-paretic) leg.
Study objective
Primary Objective: To establish the effect of asymmetrical guidance provided by
the Lokomat exoskeleton on levels of muscle activity in persons with post
stroke hemiparesis.
Secondary Objective(s): (i) To establish if the abovementioned effects (see
primary objective) depend on gait speed (ii) To establish if the abovementioned
effects (see primary objective) differ between the affected and unaffected leg
of patients.
Study design
Participants will be required to walk in the Lokomat while electromyography
(EMG) will be used to record activity of both legs from the following 5
muscles: (1) Vastus medialis (2) Rectus femoris, (3) Biceps femoris, (4)
Gastrocnemius medialis and (5) Tibilis anterior.
During Lokomat walking, guidance will be set to either 30% or 100%, for each
leg separately, resulting in symmetric (both legs received 30 or 100% guidance)
or asymmetric (one leg received 30 and the other 100% guidance) trials at two
treadmill speeds (1 or 2 km/h). During the first eight trials, a unique
combination of treadmill speed and guidance will be presented. After this, the
same eight trials are presented for the second time in the reverse order
resulting in a total of sixteen trials performed in the Lokomat. In addition,
both speed levels will also be presented outside the exoskeleton on the
treadmill (two trials). So, a total of eighteen trials will be performed.
Intervention
A total of 20 (2 for each muscle; 10 per leg) self-adhesive electrodes will be
placed on the skin of the participants.
Study burden and risks
Participation in this study is without any risk.
Walking in the exoskeleton may be somewhat fatiguing to some people, when
extremely low treadmill speeds (< 2km/h) are used. Because participants wear a
harness, and the treadmill is equipped with hand rests, participants will not
be able to fall. In case of unexpected calamities, the experimenter as well as
the participant can press an *emergency-stop*, which will halt the treadmill
and the exoskeleton immediately. In addition, the Lokomat has a built-in safety
mechanism which will halt the apparatus immediately in case unexpected
movements are detected. If walking in the Lokomat becomes uncomfortable for
some reason (e.g. skin irritation, pain in muscles/tendons), the participant
can indicate this and the experiment will be paused or aborted.
During testing, the patient*s physiotherapist will also be present. The
therapist is certified for making adjustments to, and training with the
Lokomat, and can provide instructions to the patient for easier progress of the
test, or can relieve discomfort when necessary.
The required gait activity of participants is similar to everyday walking. The
participant is not likely to experience any burden from the electrodes of the
EMG system. In the light of the relatively low burden and the small risks
associated with this study, it seems justified to conduct this study because it
may yield important information on whether asymmetrical training can be a
useful training strategy in the treatment of gait problems in this population.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
1. A first unilateral stroke (infarction or haemorrhage).
2. At least three months post onset.
3. A unilateral paresis of the leg.
4. A Functional Ambulation Categories Score (FAC) of 2 (*Patient requires manual contact of one person during ambulation on level surfaces*) to 5 (*Ambulation is independent on unlevel and level surfaces, stairs, and inclines*).
5. Patient should be 45 - 70 years old at the time of inclusion
6. Written informed consent
Exclusion criteria
1. Severely impaired cognitive functions (Mini Mental State Exam score *25).
2. Severe speech, language or communication disorders (it will be left to clinical judgment whether the patient is able to understand instructions and to provide informed consent; in case of doubt the Aachen Aphasia Test will be administered).
3. Insufficient working knowledge of the Dutch language to understand instructions and provide informed consent (clinical judgment).
4. Severe visual problems (clinical judgment).
5. Severe neglect (clinical judgment through observation. In case of doubt, the Star Cancelation Test can be administered).
6. Polyneuropathy (clinical judgement)
7. Co-morbidity that can affect the results of the study (e.g. pre-existent problems in leg function or a progressive neurological disorder).
8. Participation in other scientific studies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63078.042.17 |