|- candidate number||23344|
|- NTR Number||NTR5510|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2015|
|- Secondary IDs||15N153 Zuyd/ImplicitMotLearning_2.0/MotionLab|
|- Public Title||The power of implicit motor learning 2.0
Application of analogy, errorless and observational learning after stroke
|- Scientific Title||Analogy, errorless and observational learning for improving gait pattern and velocity in clients after stroke tested in the laboratory.
|- hypothesis||Applying analogy, errorless and observational learning can for improve gait velocity and temporal-spatial gait parameters in clients after stroke.|
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- Inclusion criteria||Potential participants will need to fulfill the following criteria:|
-have a hemiparesis
-be able to walk 10 meters without manual assistance
-would like to improve their walking ability
-have a low walking speed (cut-off for self-selected gait speed <1.0m/s56)
-are able to visit one of the motion labs (either at Zuyd University in Heerlen or at Maastricht University)
-understanding of the Dutch language, enough to follow the a simple instruction
-signed informed consent
|- Exclusion criteria||-additional impairments which are not related to stroke but can influence the gait pattern (e.g. severe osteoarthritis or amputation of the lower limb, |
-additional neurological impairment (e.g. Parkinsonís Disease).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2015|
|- planned closingdate|
|- Target number of participants||75|
|- Interventions||Every participant will receive one of the implicit learning strategies (analogy, errorless or observational learning). Allocation of the strategies is determined at random. During a session within the gait laboratory, each learning strategy will be applied in three different ways aiming at improving three different characteristics of the gait pattern. Instructions belonging to the application are given to the participant. He/she is encouraged to use these instructions during a short walks. This is repeated 3 times per application. After a short break the same procedure is repeated for the next application. |
|- Primary outcome||Primary outcome variable are changes in temporal and spatial aspects of the gait pattern (amongst others gait width and step length), measured by the Vicon 3D motion capture system.|
|- Secondary outcome||Compensatory movements will be analyzed separately and for each strategy apart. Data will be screened for often occurring compensation like e.g., increase in lateral flexion of the trunk, or hip hitching.
|- Timepoints||There are two measuring points interspersed with one week. At both measuring moments gait analysis will take place as described below (duration approximately one hour). |
|- Trial web site||www.M-I-N-D.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr Susy Braun|
|- CONTACT for SCIENTIFIC QUERIES||Dr Susy Braun|
|- Sponsor/Initiator ||Zuyderland Medical Center, Heerlen, Zuyd University of Applied Sciences, Research Centre for Autonomy and Participation of people with a chronic illness, Maastricht University Medical Center (MUMC+), Adelante Centre of Expertise in Rehabilitation and Audiology|
(Source(s) of Monetary or Material Support)
|Stichting Innovatie Alliantie (SIA)|
|- Brief summary||Introduction
Healthcare professionals working in rehabilitation, like physiotherapists and occupational therapists, are experts in supporting relearning of motor tasks in people with a disability. When supporting the learning process of people after stroke, physiotherapists and occupational therapists are confronted with cognitive impairments that often occur within this target group and may hinder the learning process.
New insights from more fundamental research confirm the assumption that implicit learning is an approach that makes motor learning easier for clients with cognitive impairments. However, the results of these studies cannot be generalized to daily practice yet. Therefore, it remains unclear how implicit learning in daily practice, aimed at learning daily movements like walking, should be shaped and whether it is effective to optimally stimulate clients. |
In this study it will be established which aspects of walking are improved by using three different applications of implicit motor learning.
Which potential effective applications of analogy, errorless and observational learning can be identified for improving gait in clients after stroke?
A cross-sectional experimental study in a motion lab (Maastricht University and Zuyd University of Applied Sciences) with 3D-movement analysis.
Intervention: Within the motion lab (3D motion capture system from Vicon), strategies will be investigated in controlled conditions to examine which applications seem useful. There are several applications of each strategy. Participants will be randomly assigned to own of the three strategies.
There are two measuring points interspersed with one week. At both measuring moments gait analysis will take place as described below (duration approximately one hour). During the first measuring point additional information is retrieved from the participants regarding characteristics and possible effect modifiers.
75-90 clients after stroke in the subacute (> 3 months) and chronic rehabilitation phase (> 6 months).
Primary outcome variable are changes in temporal and spatial aspects of the gait pattern. Potential confounders will be measured and taken into the analysis.
|- Main changes (audit trail)|
|- RECORD||2-nov-2015 - 7-jan-2016|