No registrations found.
ID
Source
Health condition
The study is targeted at people after stroke who are in the chronic stage of recovery.
Stroke, CVA
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter in work package A is walking speed measured using the 10-Meter Walk Test
The central outcome parameter in work package B is the technology acceptance of the Stappy-system
Secondary outcome
Secondary outcome measures include: dual-task performance, quality of gait (modified Dynamic Gait Index), the propensity for conscious processing (Movement Specific Reinvestment Scale), the participants' satisfaction (Likert-scale), and quality of life (Stroke Specific Quality of Life
Secondary outcomes of interest in work package B are the feasibility of the Stappy-system and potential effects on walking performance (walking speed).
Background summary
Objective: The objective of this study is 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
Demographic data: Age, gender, Length, time post stroke, side of stroke, walking aids, educational level, Montreal Cognitive Assessment, Berg Balance Scale, Rivermead Mobility Index, Fugl-Meyer Assessment, Movement Specific Reinvestment Scale
Work package A: The main outcome parameter is walking speed measured using the 10-Meter Walk Test. Secondary outcome measures include: quality of gait (modified Dynamic Gait Index), dual-task performance, the participants' satisfaction (Global Perceived Effect), the propensity for conscious processing (Movement Specific Reinvestment Scale) and quality of life (Stroke and Aphasia Quality of Life Scale-39).
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.
Study objective
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
Study design
T0: 0-weeks (baseline)
T1: 4-weeks
T2: 8-weeks
Intervention
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).
Susy Braun
Nieuw Eyckholt 300
Heerlen 6400 AN
The Netherlands
+31 45-4006366
s.braun@hszuyd.nl
Susy Braun
Nieuw Eyckholt 300
Heerlen 6400 AN
The Netherlands
+31 45-4006366
s.braun@hszuyd.nl
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)
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
could not ambulate on level surfaces without manual contact of another person (Functional Ambulation Scale (FAC) < 3)
Design
Recruitment
IPD sharing statement
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 |
---|---|
NTR-new | NL6133 |
NTR-old | NTR6272 |
CCMO | NL.60338.096.16 |