The aims of the present study are (1) to assess the immediate effect of a restraining force during treadmill walking on propulsion, (2) to assess what strategy stroke patients use to increase their propulsive force and (3) to assess if stroke…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ground reaction forces.
Secondary outcome
(1) spatial and temporal gait variables, (2) EMG amplitudes of seven muscles of
both legs, (3) hip, knee and ankle joint angles and (4) perceived exertion.
Background summary
Gait recovery is a major goal of rehabilitation after stroke [Bohannon 1998].
Propulsion is one aspect of gait that is often affected after a stroke [Awad et
al., 2014; Bowden et al., 2006; Chen et al., 2005; Sousa et al., 2013].
Propulsion can be defined as the forward component of the ground reaction force
[Hsiao et al., 2016]. In healthy adults, the negative force during heelstrike
is compensated by the positive work during toe-off of the contralateral leg. In
stroke patients, this negative force during heelstrike is not compensated by
the positive work during toe-off. Therefore, paretic propulsion is seen as a
limiting factor in functional gait performance [Awad et al., 2014; Bowden et
al., 2006; Chen et al., 2005; Sousa et al., 2013].
Improvements in paretic propulsion have shown to go along with improvements in
functional balance, walking function (i.e. walking speed and long distance
walking ability) and self-perceived participation [Awad et al., 2014; Nadeau et
al., 1999]. Therefore, training propulsion is beneficial for stroke patients.
However, a strategy that can be broadly applied is not that straightforward.
Strategies using functional stimulation [Awad et al., 2014] or assistive
devices [Forrester et al., 2016] have shown improvements in paretic propulsion.
More simple strategies like body-weight supported treadmill training, however,
are unable to show improvements in propulsion [Combs et al., 2012].
Perturbing the forward movement during gait is known to induce a higher
propulsive force [Lewek et al., 2018]. This perturbation can be established by
placing a simple pulley-system behind the treadmill. Previous research already
showed that such a restraining force during treadmill walking leads to
improvements in paretic propulsion [Lewek et al., 2018]. There are several
strategies stroke patients can use to increase propulsion during gait. One
option is to use the hip muscles during pull-off to increase the trailing limb
angle [Nadeau et al., 1999]. Another option is to use the plantarflexor muscles
during push-off to increase ankle moment [Nadeau et al., 1999]. These
strategies can differ between individuals, but also between legs [Hsiao et al.,
2016]. For training purposes, it is informative to know how stroke patients
coordinatively solve the problem. In addition, we wish to address if they will
use the same strategies as healthy participants to generate a higher propulsive
force.
Study objective
The aims of the present study are (1) to assess the immediate effect of a
restraining force during treadmill walking on propulsion, (2) to assess what
strategy stroke patients use to increase their propulsive force and (3) to
assess if stroke patients use a different strategy to increase their propulsive
force compared to healthy age-matched adults.
Study design
This is an explorative study with a mixed design with repeated measures and two
groups. Participants (15 chronic stroke patients and 15 healthy gender and
age-matched controls) will walk on a treadmill during six conditions with a
duration of 90 seconds each. The measurement session will have a total duration
of approximately two hours. Before participation in the study, each participant
will sign a written informed consent form. Travel expenses will be reimbursed
and all participants will receive a gift card to compensate for their invested
time and effort.
First, participants will walk on the treadmill (Motek, Amsterdam, The
Netherlands) at 0.28 m/s and 0.56 m/s (the speed levels will be offered in a
randomized order) without the pulley-system. Next, participants will walk on
the treadmill with the pulley system attached to their pelvic brim with a load
of 5 percent and 10 percent of their body weight attached to the pulley-system
at 0.28 m/s and 0.56 m/s (these four conditions will be offered in a randomized
order). The acceleration of the weight attached will be measured using a Trigno
wireless sensor (bandwidth: 20-450 Hz; Delsys, Natick, MA, USA) to be able to
calculate the exact restraining force (according to F=m*a).
Ground reaction forces of both legs will be measured using two force plates
that are incorporated into the treadmill. We can infer the propulsive force
based on this ground reaction force (primary objective). In addition, with the
ground reaction force, we can calculate the step length, step width and
stance/swing durations. These gait variables may help us to say something about
the strategy the participant uses to increase his/her propulsive force (first
secondary objective).
In addition, to say something about the strategies the participants use to
increase the propulsive force (first secondary objective) we will also measure
muscle activity and joint angles. During all (six) conditions, muscle
activation patterns will be measured bilaterally using surface electromyography
(EMG) from: Gluteus Medius, Biceps Femoris, Rectus Femoris, Vastus Medialis,
Mediale Gastrocnemius, Soleus and Tibialis Anterior. Joint angles of the hip,
knee and ankle will be measured bilaterally using Xsens.
To assess the difference between stroke patients and healthy controls (second
secondary objective), we will measure, besides the above mentioned variables,
the rate of perceived exertion. The heart rate and the Borg scale will be
measured/administered before the experiment and directly after each condition.
Lastly, several characteristics of the participants will, if applicable, be
collected for descriptive purposes: score on the *single leg heelrise test*,
use of medicine, location of the stroke (left/right and subcortical/cortical),
gender, age, time poststroke in months, type of the stroke
(haemorrhagic/ischaemic), type of paralysis (spastic or non-spastic), surgery
after the stroke with the aim to improve gait ability, history of botulin toxin
injections, FAC score, use of walking aids, leg length, body length and body
weight.
Intervention
Walking on a treadmill during six conditions (see study design).
Study burden and risks
Because the participant is wearing a harness (similar to a parachute harness)
while walking on the treadmill that is attached to a suspension anchored in the
ceiling and the treadmill is equipped with hand rests, it is not possible to
fall. In the event of unexpected incidents or inconveniences, both the
investigator and the participant can press an emergency button that immediately
stops the band.
The session will last approximately 2 hours. Of this time, only (6 measurements
* 90 seconds =) 9 minutes will be spent walking on a treadmill. In addition,
there will be a pause of at least 5 minutes after each measurement. If the
subject wants a longer break, this is permitted. Experience shows that stroke
patients (and healthy people) tolerate this burden without many problems. In
addition, a physical therapist will be present during measurements with
patients who can monitor the well-being of the patient.
If emergencies occur, both the participant and the researcher can immediately
stop the treadmill by pressing an emergency button. If walking on the treadmill
is uncomfortable for whatever reason (for example due to skin irritation of the
electrodes or pain on muscles/tendons) this can be indicated and the
measurement will be paused or interrupted in consultation with the participant.
Most of the time the electrodes, sensors and heart rate belt do not cause
inconvenience. In view of the low burden and the low risk, it seems justified
to carry out such a study because it can provide important information for
developing training for the walking ability of stroke patients.
Antonius Deusinglaan 1
Groningen 9713AV
NL
Antonius Deusinglaan 1
Groningen 9713AV
NL
Listed location countries
Age
Inclusion criteria
Patients:
- A first unilateral stroke (infarction or haemorrhage).
- At least twelve months post onset.
- A unilateral paresis of the leg.
- A Functional Ambulation Categories Score (FAC) of 3 (*is capable of walking
when a safer environment with supervision or verbal guidance is provided'*) to
5 (*is independently capable of walking on flat and non-flat surfaces, on
slopes and is capable of walking the stairs*).
- Patient should be 18-70 years old at the time of inclusion.
- Written informed consent
Healthy controls:
- Participants should be 18-70 years old at the time of inclusion.
- Participants should match with one of the included patients on gender and
age.
- Written informed consent
Exclusion criteria
Patients:
- Severely impaired cognitive functions (Mini Mental State Exam score <25).
- 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).
- Insufficient working knowledge of the Dutch language to understand
instructions and provide informed consent (clinical judgment).
- Severe visual problems (clinical judgment).
- Severe neglect (clinical judgment through observation. In case of doubt, the
Star Cancelation Test can be administered).
- Co-morbidity that can affect the results of the study (e.g. pre-existent
problems in leg function or a progressive neurological disorder).
- Participation in other scientific studies.
- Use of botulin toxin injections in the lower extremities or oral spasmolytic
in a period of two months prior to the measurement.
- Use of an active splint that delivers energy for forward propulsion.
Healthy controls:
- Suffer from neurological, orthopedical, somatosensory, visual, vestibular or
other conditions that are known to affect the gait pattern.
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 | NL73086.042.20 |