a. To establish the effects of (1) body weight support (2) treadmill speed, and (3) level of guidance/ movement support, on the neuromuscular control of the lower extremities in patients with post-stroke hemiparesis, and to determine possible…
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
The Lokomat is a position-controlled exo-skeleton that can be used to train
gait skills in stroke patients with impaired gait. During training in the
Lokomat, the following parameters can be set: (1) speed of the treadmill (2)
the level of body weight support (3) the level of movement support or
*guidance*. For adequate use of these parameters, and for the development of
treatment protocols for the Lokomat, it is important to understand how these
training parameters affect the gait pattern of patients. In addition, it is
important to know the extent to which, over different training sessions,
patients react in a stereotyped fashion to the training parameters or whether
they show a large session-to-session variability in their gait patterns in the
Lokomat. A logical strategy to assess these gait patterns is to record the
muscle activity that is responsible for the production of these patterns.
Study objective
a. To establish the effects of (1) body weight support (2) treadmill speed, and
(3) level of guidance/ movement support, on the neuromuscular control of the
lower extremities in patients with post-stroke hemiparesis, and to determine
possible differences in these effects (1) between patients and healthy,
age-matched controls, and (2) between the impaired and unimpaired leg in
patients.
b. To compare the patterns of muscle activity displayed in in the exo-skeleton
of the Lokomat, and during walking on the treadmill outside the exo-skeleton,
and to determine whether the effects of the exo-skelton differ between
hemiparetic stroke patients and their healthy peers.
c. To determine the between session variability in muscle activity in the
Lokomat, and to establish possible differences in between session variability
between hemiparetic stroke patients and their healthy peers.
Study design
Participants will be required to walk in the Lokomat while activity is
recorded by means of electromyography (EMG) from the following 5 muscles: (1)
Gastrocnemius medialis (2) Tibialis anterior (3) Vastus medialis (4) Biceps
femoris and (5) Gluteus medius. In patients, these muscles will be recorded in
both legs, whereas in healthy subjects only the preferred leg will be assessed.
During each individual trial, a unique combination of treadmill speed (2
levels: 1.0, and 2.0 km/h), body weight support (0% and 50% of the
participant*s body weight), and guidance (50%, and 100%) will be presented. In
total, participants will perform (2x2x2=) 8 trials in the Lokomat. In addition,
all combination of body weight support and treadmill speed will also be
presented outside the exo-skeleton on the treadmill (4 trials). So, a total of
12 trails will be performed.
To establish the inter-session variability and to compare this between healthy
and hemiplegic walkers, the trails in the Lokomat exo-skeleton will be repeated
for each participant between 7 and 14 days after the first test session.
Intervention
A total of 10 (2 for each muscle that will be recorded) self-adhesive
electrodes will be placed on the skin of participants. In patients, activity
from both legs will be recorded.
Study burden and risks
Walking in the exoskeleton may be somewhat fatiguing to some people, when
extremely low treadmill speeds (< 2km/h) and high levels of body weight support
(> 30% of body weight) 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 a *emergency-stop*, which will halt the treadmill and the
exo-skeleton 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 of patients, his/her physiotherapist will present. The therapist
is certified for making adjustments to and training with the Lokomat, and can
provide extra instructions to the patient for easier progress of the test, or
can relieve or take away 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 that can be used to develop training protocols
for neurological patients.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
1. First ever, unilateral stroke (infarction or hemorrhage)
2. At least 3 months post onset
3. Unilateral paresis of the leg
4. A Functional Ambulation Categories Score of 2 (Patient needs continuous or intermittent support of one person to help with balance and coordination**), 3 (*Patient requires verbal supervision or stand-by help from one person without physical contact*), or 4 ('*Person can walk independently on level ground, but requires help on stairs, slopes or
uneven surfaces*).
5. Patient should be older than 18 years to be included
Exclusion criteria
1. Severely impaired cognitive functions (Mini Mental State Exam score <=25)
2. Severe speech, language or communication disorders (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 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. Co-morbidity that can affect the results of the study (e.g. pre-existent problems in leg function or a progressive neurological disorder).
7. 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL46137.042.13 |
| OMON | NL-OMON28557 |