|- candidate number||26856|
|- NTR Number||NTR6272|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mrt-2017|
|- Secondary IDs||NL.60338.096.16 NL number|
|- Public Title||Implicit motor learning in gait training after stroke|
|- Scientific Title||Implicit and explicit motor learning during gait rehabilitation and the use of simple technologies to support independent gait training at home in people after stroke|
|- hypothesis||Work package A|
The aim of work package A is to examine the effectiveness of analogy learning (based on implicit motor learning principles) compared to explicit motor learning on walking performance in people after stroke.
Work package B
The primary aim of work package B is to evaluate the acceptability of the Stappy-system for independent gait training in daily life in people after stroke. Secondary aims are to assess the feasibility and potential first effects on walking performance of the Stappy-system in people
|- Healt Condition(s) or Problem(s) studied||Stroke, Stroke|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria. The person|
has had a stroke and is in the chronic stage of recovery (> 6 months after stroke)
wants to improve his/her walking performance
has a walking speed slower than 1.0 m/s (there is limited space for improvement if walking speed would be too high (ceiling effect)
is able to communicate in Dutch langue, at least to understand the verbal instructions of the physiotherapist
has the ability to complete a 3-stage command
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study. The person|
cannot walk a minimal distance of 10 meters (if necessary with manual assistance or walking aid)
has additional diagnosed impairments, not related to stroke, that can influence the gait pattern e.g. severe osteoarthritis or amputation of the lower limb
has additional diagnosed neurological impairments e.g. Parkinsonís Disease that can influence their walking performance
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2017|
|- planned closingdate|
|- Target number of participants||80|
|- Interventions||Depending on randomisation, participants will receive a gait training based on implicit motor learning principles (experimental group) or based on explicit motor learning principles (control group).|
|- Primary outcome||The main outcome parameter in work package A is walking speed|
The central outcome parameter in work package B is the technology acceptance of the Stappy-system
|- Secondary outcome||Secondary outcome measures in work package A are quality of gait (Spatiotemporal gait parameters, Dynamic Gait Index), the participants satisfaction (Likert-scale), the general level of mobility (Rivermead Mobility Index) and quality of life (Stroke and Aphasia Quality of Life Scale).
Secondary outcomes of interest in work package B are the feasibility of the Stappy-system and potential effects on walking performance (walking speed).
|- Timepoints||T0: baseline|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr Susy Braun|
|- CONTACT for SCIENTIFIC QUERIES||MSc Li-Juan Jie|
|- Sponsor/Initiator ||Zuyd University of Applied Sciences, Research Centre for Autonomy and Participation of people with a chronic illness|
(Source(s) of Monetary or Material Support)
|Stichting Innovatie Alliantie (SIA)|
|- Brief summary||Objective: The objective of this study in twofold. The first objective is to study the effectiveness of implicit motor learning on walking speed in clients after stroke in daily practice. The second objective is to determine the technology acceptance, feasibility, and first effects on walking performance of the Stappy-system.|
Study design: This research protocol involves two work packages A (objective 1) and B (objective 2). In work package A, a randomized, controlled, single blinded study design will be adopted. Work package A will be followed by work package B in which a prospective process evaluation of a technology intervention will take place.
Study population: The same participants will take place in both work packages A and B. People will be eligible for participation if they have had a stroke (>6 months after stroke), would like to improve their walking performance, have a slower walking speed than (10 m/s), can communicate in Dutch language (enough to understand the instructions), and can follow a 3-stage command. People will be excluded for participation if they cannot walk a minimum of 10 meters, or have other additional impairments that may influence their gait.
Intervention: Work package A consists of a 3-week intervention period that includes 3 training sessions per week. The experimental group receives gait training based on implicit learning principles and the control group will receive gait training based on explicit learning principles. In work package B, the participants will receive an easy-to-use technology (Stappy-system) to support their gait exercises independently at home.
Main study parameters/endpoints: Work package A: The main outcome parameter is walking speed measured in single and dual task conditions. Secondary outcome measures include: quality of gait (Spatiotemporal gait parameters, Dynamic Gait Index), the participants satisfaction (Likert-scale), the general level of mobility (Rivermead Mobility Index) and quality of life (Stroke Specific Quality of Life Scale).
Work package B: The main outcome parameter for work package B is the technology acceptance of the Stappy-system. Secondary outcomes are based on the feasibility and potential first effects on walking performance.
|- Main changes (audit trail)||8-mei-2017 - MT: Research center Zuyd University of Applied Sciences, Research Centre Technology in Care replaced by Zuyd University of Applied Sciences, Research Centre for Autonomy and Participation of people with a chronic illness|
|- RECORD||10-mrt-2017 - 14-mei-2017|