The aim of the present study is to assess the effectiveness of the FALLS-Program in community-dwelling stroke patients. Before and after the intervention, participants balance will be tested using numerous of clinical tools, support-surface…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Due to the small sample size of the present pilot study, falls incidence alone
is not a good tool to evaluate the effect of the FALLS-program. The Nijmegen
Falls Simulator requires restoration of standing balance, by either keeping the
feet in place or taking a step, and the Target Stepping Task provokes online
step adjustments. These are situations in which people with stroke are at high
risk of falling. Improvement on these tasks will be evidence of improving
balance and gait abilities during perturbations. Therefore the primary outcomes
of the present study are the extent of centre of mass displacement during
support surface perturbations and the number of foot placement errors on the
Target Stepping Task.
Secondary outcome
Secondary outcomes are: Falls incidence, onset latencies and speed of
correction on the Target Stepping Task, amount of stepping and onset latencies
of muscle activation during support-surface perturbations, Falls efficacy
Scale, Berg Balance Scale, Timed Up&Go-test and 10 meter walking test.
Background summary
In the Netherlands, an estimated 41.000 people sustain a first ever stroke
every year. Due to remaining functional deficits, falls are a common
complication after stroke. Balance and gait deficits are identified as
important risk factors. A falls prevention program (the FALLS-program) will be
designed that will focus on these deficits.
Study objective
The aim of the present study is to assess the effectiveness of the
FALLS-Program in community-dwelling stroke patients. Before and after the
intervention, participants balance will be tested using numerous of clinical
tools, support-surface translations a target stepping task.
Study design
The present study is a pilot study, using a within-subjects design. Twelve
persons with stroke will be assessed before and after the intervention. These
two assessments will be compared. Assessments will consists of support-surface
perturbations on the Radboud Falls Simulator, a Target Stepping Task requiring
online step adjustments and several clinical tools. These assessments simulate
the complex balance tasks of daily life, during which people after stroke are
most likely to fall.
Intervention
The FALLS-program is based on the *The Nijmegen Falls Prevention Program*, a
demonstrated effective 5-week exercise program, designed for community-dwelling
elderly with a history of falling. It will consist of an obstacle course
(designed to train balance, gait and coordination), walking exercises (where
adjustment in walking speed and direction are required) and martial arts based
fall techniques. Participants will take part in groups of 6 people and will
receive 5 weeks of training, 2 days a week, duration 1.5 hours.
Study burden and risks
Participants will spend approximately 25 hours on this study (15 on trainings,
10 on assessments). They will benefit from the trainings, as their balance and
gait abilities are expected to improve.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
18 to 80 years-old
Sustained a stroke more than six months ago
Received inpatient rehabilitation in the past two years
Independently walking (FAC >4)
Exclusion criteria
Other musculo-skeletal conditions which can influence balance or gait ability
Conditions in which physical activity is contra-indicated
Use of psychotropic drugs
Cognitive/behavioural problems
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 | NL32681.091.10 |