The aim is to convince the rehabilitation community that drop foot after stroke can be functionallycorrected which increases significantly quality of life. The information will be spread throughrehabilitation centers targetting rehab physicians,…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures:
* Gait parameters: walking speed, gait symmetry, gait width, foot
placement,cadence,gait fluency,
* Two minute walking test (Brooks 2001, Datta 1996)
* Functional gait performance: - outdoor circuit with different surface
textures (Kölgen et al., 2002),
indoor participation circuit (Hemmen et al., 2007; Stevens et al., 2006; Ilmer
et al., 2007)
- Family Qol & Stroke specific utlities.(see attachment)
- Generic quality of life: SF-36 (vd Zee et al., 1993)
Secondary outcome
Secondary outcome measures:
* * Functional health status: Functional Independence Measure (FIM) (Kidd et
al., 1995)
* Anxiety and depression: HADS (Spinhoven et al., 1997)
Cognitive functioning: MMSE (Jackson et al., 2007)
* Functional health status,
. Functional independence measure (FIM)
* Credibility/expectancy questionnaire (CEQ) (Devilly & Borkovec, 2000)
Background summary
The incidence of cerebrovascular accidents (CVA) in the Netherlands is
estimated to be 30.000 a
year.(NHG-Standaard CVA , verhoeven et al 2004).Twenty percent die, 20% survive
without
neurological deficit and 60% have a partial recovery of which 50% (9000) have
walking problems.
(Bonita 1998) Early rehabilitation results in a better functional recuperation
(Kwakkel 1999) 3/4 of the
patients with a walking problem return to adequate functioning after 3 months
(Kwakkel 1999, Jorgensen
1995, a, b) Approximately 30% do not recuperate (Wade 1987). The incidence of
CVA with the
increasing age of the population will result in 35000 CVA cases a year in 2015.
The LMR data give an
incidence of 44.320 for the year 2006.
Hoensbroek is the largest rehabilitation center in Limburg with connections to
all large hospitals. A
working group with participants from all departments and focused on this
project covers the whole
population of Limburg. (1.2 milj)
Study objective
The aim is to convince the rehabilitation community that drop foot after stroke
can be functionally
corrected which increases significantly quality of life. The information will
be spread through
rehabilitation centers targetting rehab physicians, physiotherapists in the
Netherlands. We now
approached all rehabilitation department and nursing houses in the region. They
are committed to the
project and a working group is created to update and train participants. If we
are successful the
programm will be dissiminated through the country in a restricted number of
rehabilitation centers.
Study design
Piolt study related to a larger study which belongs to the cost effective area
as defined by ZonMW. Proposal is submitted in september.
Intervention
Surgical intervention of an inerve stimulating device which consists of 2
parts. The electrodes are fixed on the nerve and the receiver is placed
subcutaneously. The pulse generator is placed on the skin. This is a minor
surgery. However as it concerns an implant care must be taken to avoid
infection. Antibiotics are given for 24 h.
Study burden and risks
The disease is an upper motor neuron deficit with a dropfoot as major clinical
impairment. The condition
is found in CVA, MS and spinal cord lesions. This study focuses on CVA patients
as this group is the
largest.
A cerebrovascular accident accompanied by a hemiparesis may apart from the
cognitive impact reduce
the mobility of the patient. The walking imbalance restricts the patient
activities and increases the risk of
falling resulting in a important reduction of the quality of life. Usual
therapy consists in stabilization of the
walking problem by physiotherapy and/or orthosis. This does not eliminate
abnormal walking. Important
amelioration may be expected from an active correction of the imbalance by
electrical stimulation of the
involved nerves.
Risks for the patients are comparable to all other surgical minor intervention
where a small device has to be implanted. Comparable with a neurostimulator or
pacemaker.
P Debijelaan 5
6202 AZ Maastricht
NL
P Debijelaan 5
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
* age ><= 18 years;
* first ever supratentorial stroke with persistent neurological deficit
* post-stroke time between 6 and 24 months;
* Diagnosis and stroke severity
* BARTHEL INDEX * 15
*
* clinically diagnosed central paresis of the leg;
* drop foot, i.e. inability to achieve a normal heel strike during walking
* balance and gait-related criteria: subject is an outdoor walker:
* Berg Balance score 48/56;
* Rivermead mobility index 11/15.
* strength MRC grade * 3 at entry into the study
* no injury to peroneal nerves and sciatic nerve
* ( EMG to exclude peripheral nerve lesion,
* trial stimulation to evaluate dorsiflexion and eversion of the foot)
.
Exclusion criteria
* pacemaker
* any medical condition that would exclude the use of a surgical procedure or anaesthetic
* pregnancy
* inability to read or understand Dutch or receptive aphasia?
* no informed consent
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 | NL20279.096.07 |