The aim of the proposed *proof-of-principle* study is to assess the feasibility and (preliminary) effectiveness of a newly developed 5-week perturbation-based training program using the Radboud Falls Simulator (RFS) on dynamic balance capacity in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Because this study is designed to provide *proof of principle*, the primary
outcome measure is related to the efficacy of the stepping responses. Centre of
mass (CoM) displacement and step length during perturbations on the Radboud
Falls Simulator will be compared between the intervention group and the usual
care group.
Secondary outcome
Secundary outcomes will be foot postioning, leg angle and force during stepping
reactions after balance perturbations on the Radboud Falls Simulator. In
addition we will compare the intervention and the usual-care group on the
following functional tests: Berg Balance Scale, Trunk Impairment Scale, Timed
Up&Go, Ten Meter Walking Test en Activity-Balance Confidence Scale.
Background summary
In the Netherlands, an estimated 41.000 people sustain a first ever stroke
every year. Falls are a common complication after stroke, with balance and gait
disorders as its main risk factors. This can be explained by the fact that
people after stroke have an impaired capacity to execute quick stepping
reactions after a balance perturbation, particularly when de paretic leg is
involved. There is some evidence that these stepping reactions can be improved
after stroke by a perturbation based training program.
Study objective
The aim of the proposed *proof-of-principle* study is to assess the feasibility
and (preliminary) effectiveness of a newly developed 5-week perturbation-based
training program using the Radboud Falls Simulator (RFS) on dynamic balance
capacity in community-dwelling persons in the chronic phase after stroke.
Study design
This study is designed as a randomized controlled cross over trial.
Participants will be randomly allocated to an experimental group receiving the
5-week training program after one week, or to a (waiting list) control group
receiving no specific intervention (*usual care*). After a waiting period of 6
weeks, the control group will also receive the experimental training.
Intervention
A 5-week perturbation-based training program using the Radboud Falls Simulator
(RFS), based on the existing literature on balance perturbations after stroke.
This program will train sustaining single translations in eight different
directions and at increasing intensities (accelerations) necessitating step
reactions. Participants will be forced to step with both the paretic and the
nonparetic leg. Participants will receive the training in pairs during training
sessions of 90 minutes, two times a week, 5 weeks in a row, under supervision
of a trained physiotherapist. The level of difficulty will be increased each
session based on a fixed individualized protocol.
Study burden and risks
Participants will spend approximately 10 hours during assessments for this
study. Due to a safety harness, fall risk during assessments is very low. As a
experimental setup, the balance platform is already in use for several other
studies without occurrence of adverse events.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Having sustained a stroke more than 6 months ago and having completed post-acute rehabilitation
- Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories (FAC) scores 4 or 5
- Aged 18 till 75 years
Exclusion criteria
- Other neurological or musculoskeletal conditions affecting balance
- Conditions in which physical exercise is contra-indicated
- Use of psychotropic drugs or other medication negatively affecting balance
- Severe cognitive problems (mini mental state examination (MMSE) <24)
- Persistent visuo-spatial neglect (based on the Behavioural Inattention Test / BIT)
- Behavioural problems interfering with compliance to the study protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42155.091.12 |
| OMON | NL-OMON20002 |