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,…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter in work package A is walking speed measured in
single and dual task conditions.
The main outcome parameter for work package B is the technology acceptance of
the Stappy-system.
Secondary outcome
Secondary outcome measures in work package A 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 and Aphasia Quality of Life Scale).
Secondary outcomes in work package B are based on the feasibility and potential
first effects on walking performance.
Background summary
A significant part of rehabilitation focuses on facilitating motor skills. Gait
training is one of the most practiced motor skills within rehabilitation in
people after stroke. The use explicit and implicit motor learning strategies
may support physiotherapists to structure their gait training sessions. Clients
are also often encouraged to practice gait independently at home outside guided
therapy sessions. Recently an easy-to-use technology, named the Stappy-system,
has been developed to support independent gait training at home-based
environments.
Study 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.
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 (analogy Learning) and the control group will
receive gait training based on explicit learning principles. In work package B,
the participants in de experimental condition will receive an easy-to-use
technology (Stappy-system) to support their gait exercises independently at
home. The control group will not receive any support.
Study burden and risks
Work package B: Participants will be randomized into the control (explicit
motor learning) or the experimental (implicit motor learning) condition.
Interventions: Participants are asked to participate in 9 sessions during a
3-week period and to complete 3 measurement sessions. The sessions take place
at the client*s home environment. Each training session lasts for 30 minutes.
Measurements: All assessment sessions will take place the home environment of
the participants. Primary and secondary outcome measures are assessed at
baseline (T0), directly after the intervention (T1) and again 1-month after the
intervention (T2). The outcome assessments last for approximately 30 to 60
minutes.
Both conditions do not include any invasive interventions, nor any untested
measurement instruments, there is no anticipated significant additional risk to
the assessment or therapy of the participant. The measurements include
standardised tests and questionnaires that are being used within standard
clinical practice and/or research settings. Participants may possibly feel a
little fatigued after the gait training or measurement sessions.
Working package C: Participants will be randomized into the control (nothing)
or the experimental (technology) condition. Both conditions do not include any
invasive interventions, nor any untested measurement instruments, there is no
anticipated significant additional risk to the assessment or therapy of the
participant. Technology group: The technology condition requires some extra
proceedings. These involve recharging the batteries of the Stappy-system and
setting up the system (e.g. placing sensors on shoes). Control group: People in
the control group, even as people in the people in technology group will be
asked to train their gait independently at home, however they will not receive
the additional support of a technology. In both groups people will be free the
o choose when, how often (frequency) and for how long (duration) they would
like to practice with the Stappy-system over a 4-week period. If people are
allocated to the control condition while they would actually also like to try
out the technology, they will be offerend the chance to work with the
technology after the end of the study.
Nieuw Eyckholt 300 Nieuw Eyckholt 300
Heerlen 6400AN
NL
Nieuw Eyckholt 300 Nieuw Eyckholt 300
Heerlen 6400AN
NL
Listed location countries
Age
Inclusion criteria
* 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)
Exclusion criteria
* cannot walk a minimal distance of 10 meters (if necessary with manual assistance or walking aid)
* has additional impairments, not related to stroke, that can influence the gait pattern e.g. severe osteoarthritis or amputation of the lower limb
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 | NL60338.096.17 |