Aim of this proof of principle study is to develop a reliable and safe application of bilateral FES of the calf muscles to facilitate insufficient push-off in patients with MS and to assess the preliminary effects of FES on net ankle power…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In patients with MS, within-subject changes in energy cost of walking, net
ankle power and walking speed will be assessed between the conditions with FES
and without FES.
Secondary outcome
N.A.
Background summary
The majority of patients with MS experience difficulties in daily activities
and walking, and gait impairments can already be seen in the early stage of
MS. Within 15 years of diagnosis, nearly 50% of the patients requires
assistance with a walking aid, and 10% will be wheelchair dependent. A recent
PhD-study of Kempen (2013) aiming to classify distinctive gait patterns of
patients with MS has shown that reduced ankle push-off is a large contributor
to the decline in walking ability. In patients classified as moderately
impaired walkers the majority showed an inadequate push-off (90% right leg and
100% left leg).
Study objective
Aim of this proof of principle study is to develop a reliable and safe
application of bilateral FES of the calf muscles to facilitate insufficient
push-off in patients with MS and to assess the preliminary effects of FES on
net ankle power generation and energy cost of walking.
Study design
This proof of principle study consists of various experiments in healthy
participants and in patients with MS. Because of the physical strains,
experiments will be carried out in the first place in healthy participants.
Next, due to the variability of gait in patients with MS, most experiments will
be validated in patients with MS.
Intervention
Functional Electrical Stimulation of the calf muscles
Study burden and risks
The majority of patients with MS experience difficulties in daily activities
and walking, and gait impairments can already be seen in the early stage of
MS. Within 15 years of diagnosis, nearly 50% of the patients requires
assistance with a walking aid, and 10% will be wheelchair dependent. A recent
PhD-study of Kempen (2013) aiming to classify distinctive gait patterns of
patients with MS has shown that reduced ankle push-off is a large contributor
to the decline in walking ability. In patients classified as moderately
impaired walkers the majority showed an inadequate push-off (90% right leg and
100% left leg). Because the development of the stimulation algorithm is
time-consuming and requires substantial walking effort of the participants,
healthy persons will be used in the first phase of the study. In the second
phase, patients with MS will be recruited to test the developed algorithm, and
to investigate the preliminary clinical relevance.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Five healthy subjects and five patients with MS with reduced ankle push-off as shown by 3D gait analysis will be recruited. In order to be eligible to participate, only ambulatory adults (18-65 years) will be invited.
Exclusion criteria
FES is absolutely contraindicated for participants with a cardiac pacemaker. The electrical impulses may lead to disturbances of the pacemaker sensors which could cause a life-threatening situation. Pregnant women will also be excluded from participation. Dysaesthetic sensation of pain, skin injuries or open sores in the area of calf stimulation should be checked as a potential criterion for exclusion.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL49823.029.14 |