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Reactieve voetplaatsing in balanshandhaving tijdens staan en lopen in gezonde jongeren en mensen met een cerebrovaculaire aandoening


- candidate number19645
- NTR NumberNTR4841
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-okt-2014
- Secondary IDsNL5045004414 Grant Agreement 601003 FP7
- Public TitleReactieve voetplaatsing in balanshandhaving tijdens staan en lopen in gezonde jongeren en mensen met een cerebrovaculaire aandoening
- Scientific TitleReactive stepping in balance control during standing and walking in healthy young adults and stroke survivors.
- ACRONYMReactive stepping in balance control
- hypothesisWhat is the relation between body states (e.g. center of mass position and velocity) following a change in externally applied pelvic force, and the resulting swing time and stepping location used to maintain balance in standing and walking.
- Healt Condition(s) or Problem(s) studiedBalance, Stroke, Stability, Walking
- Inclusion criteriaHealthy subjects :
- between 18 and 30 years of age

Stroke survivors :
- between 18 and 70 years of age - diagnosed with a hemiparesis as the result of a first ever ischemic stroke
- > 6 months post-stroke (chronic stage)
- functional ambulation category (FAC) 4 : walk independently on level surfaces
- physical condition allows independent walking for at least 3 consecutive minutes
- stable medical condition
- sufficient cognitive abilities (mini-mental state examination >= 22)
- sufficient communication abilities (Utrechtse communicatie onderzoek >= 3)

Both :
- body weight < 100 kg
- has given written informed consent
- Exclusion criteriaHealthy subjects :
- has current lower extremity problems or deficiencies (e.g. knee problems, disabilities in walking)
- has (a history of) neurological or balance related disorders

Stroke survivors :
- has (a history of ) other neurological or balance related disorders not related to stroke

Both :
- is using medication that can affect balance control
- is pregnant, or has a chance of being pregnant
- has chronic joint pain
- has orthopedic problems
- has (a history of) cardiac conditions that interfere with physical load
- has (a history of) skin diseases that could result in irritation of the skin underneath the EMG electrodes
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate31-dec-2016
- Target number of participants60
- InterventionsForces applied at the pelvis during standing and walking to disturb balance and invoke a stepping response.
- Primary outcomeFoot placement location and swing time
- Secondary outcome- Distance between center of mass and center of pressure
- Ground reaction forces
- Joint angles
- Joint torques
- Body angular and linear momenta
- Muscle (reflexive) activity levels
- TimepointsAll instances from perturbation onset up and including to the moment of first, second and possibly third subsequent foot contact.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESIr. M. Vlutters
- CONTACT for SCIENTIFIC QUERIESIr. M. Vlutters
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Seventh Framework Programme (FP7) funded by the European Union
- Publications
- Brief summaryIn daily life the upright human body is continuously challenged by external disturbances, such as gravitational forces and forces originating from interactions with the environment. These disturbances can lead to a loss of balance, which must be acted upon accordingly to prevent a fall. Following a disturbance, proper foot placement is crucial for maintaining balance during both standing and walking. However it is unclear why humans place their foot at a certain location at a certain time following an unexpected balance disturbance. A model based prediction of a suitable foot placement location to maintain balance and prevent falls can have great value in both clinical and robotics fields of research. Investigating foot placement in stroke patients can lead to a better understanding how stroke related complications affect foot placement, and how these might be compensated using supportive devices such as exoskeletons.
- Main changes (audit trail)
- RECORD7-okt-2014 - 2-nov-2014


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