The objective of this study is to investigate whether impaired balance control is (partly) responsible for the increased energy cost of walking in stroke patients and amputees by evaluating the effect of external stabilization and destabilization on…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is energy cost of walking (in J*kg-1m-1), calculated
from breath by breath gas analysis
Secondary outcome
The following balance control related outcome parameters will be calculated:
steplength, stepwidth, trunk acceleration and the variability of these
measures, as well as gait stability and regularity. Gait stability will be
quantified with the Lyapunov exponent and gait regularity will be quantified
with the sample entropy. Additionally muscle activity will be measured in
stroke patients using surface electromyography.
Background summary
Regaining walking ability is an important rehabilitation goal. Gait economy
(i.e. the energy cost of walking) and gait stability are important aspects of
walking ability. Both of these aspects are generally impaired in patients with
movement disorders, such as stroke patients or amputees. However, it is unknown
whether the highly increased energy cost of walking in these patients is
(partly) the result of impaired balance control. Finding the cause of the extra
energy cost during walking is important to develop adequate interventions to
regain and maintain walking ability during and after the rehabilitation
process.
Study objective
The objective of this study is to investigate whether impaired balance control
is (partly) responsible for the increased energy cost of walking in stroke
patients and amputees by evaluating the effect of external stabilization and
destabilization on the energy cost of walking.
Study design
Cross-sectional study
Intervention
For amputees: An external stabilization device consisting of spring like chords
will be used to facilitate balance control during walking on a treadmill. A
destabilizing task task, in which subjects have to walk on an imposed
(projected) step pattern, will be used to impede balance control.
For stroke patients: Balance control will be facilitated by providing handrail
support while walking. In one condition subjects are allowed mechanical support
of the handrail, while in a second condition only light touch is allowed
(providing somatosensory information). This will be compared to an unsupported
condition.
Study burden and risks
During the experiment, subjects will complete one questionnaire about their
balance confidence. Furthermore all subjects will complete five practice
walking trials and four experimental walking trials on a treadmill with a
duration of five minutes each. Due to the measurement of metabolism all
subjects will be asked to refrain from heavy exercise the day of the experiment
and abstain from food at least one hour prior to the experiment.
The mental and physical burden and risk*s of the experiment for the
participants are low. The experiment will take approximately 1.5-2 hours to
complete and the intensity of the walking trials is low. During the walking
trials participants will wear a safety harness to prevent falling. Furthermore
the treadmill is equipped with a double emergency stop (one manual stop, and an
electronic eye at the back of the belt).
van der Boechorststraat 9
Amsterdam 1081 BT
NL
van der Boechorststraat 9
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
All subjects: above age 18 years and able to walk on a treadmill during five uninterrupted minutes from which the last three minutes without handrail support. Additionally they have to be able to walk an imposed step pattern.
Stroke patients a score of 4 or higher on the Functional Ambulatory Category (FAC)
Amputees a SIGAM mobility scale D-F (being able to walk more than 50 meters independently on an even surface with or without an assistive device), and a proper fitting prosthesis for at least six months.
Exclusion criteria
All subjects: cognitive and communicative disorders that could interfere with the protocol, cardiovascular or pulmonary co-morbidities contra-indicating moderate exercise, visual impairments that could interfere with the protocol, and medication and/or co-morbidities that could interfere with balance control or energy expenditure.
Amputees: stump problems (pain, swelling, pressure sores) and significantly fluctuating stump volume within the last six months.
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 | NL43003.029.12 |