To determine whether Wii balance therapy is more effective than the conventional balance therapy for the standing and walking balance of patients with a stroke.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter of the study is balance measured with the Berg
balance scale and the Dynamic gait Index.
Secondary outcome
Intensity of exercising:
The intensity of exercising is the duration and frequency in which the patient
performs the balance exercises. The intensity is determined by means of a diary
in which the patient records when and how long (minutes) he / she performs the
balance exercises, and by using a self-questionnaire that asks patients how
often per week and for how long (minutes) they have practiced.
Prognostic factors:
Prognostic factors are the factors that may affect the restoration of balance.
The prognostic factors age, sex, social status are derived from the patient
file. Therapy adherence is measured with a diary and a self-questionnaire.
Activities of daily living:
Activities of daily living (ADL) are the basic tasks of everyday life. The
extent to which the patient independently perform ADL is measured with the
Barthel index.
Participation:
Participation is a person's actual involvement in society. Participation is
measured with the Life Habits questionnaire.
Quality of life:
Quality of life is being defined and measured as the functioning of persons in
the physical, psychological and social field (or dimension), and its subjective
evaluation. Quality of life is measured with the SF-36.
Background summary
Patients with a stroke often have impaired balance. Therefore, these patients
have an increased risk of falling, which can lead to serious complications such
as hip fractures. Balance training leads to a reduction (41-65%) of the number
of falls. The problem is that balance therapy, which mostly consists of home
exercises, is often considered as boring. This requires a lot of the patient's
discipline to consistently carry out the prescribed balance exercises. The
result is that a significant number of patients (20-60%) don't perform the
exercises or only partially, which leads to a significant decrease of the
therapeutic effect. Hence, the therapeutic effect depends largely on the
intensity (duration and frequency) in which the patient perform the exercises.
A possible solution to improve the effectiveness of balance therapy is the use
of interactive 'video games'. We know from research and our own experience that
patients are more motivated to perform exercises with interactive video games.
This may have a positive effect on the intensity of exercising and therefore
the therapeutic effect.
Study objective
To determine whether Wii balance therapy is more effective than the
conventional balance therapy for the standing and walking balance of patients
with a stroke.
Study design
It is a randomized single-blind parallel clinical trial to determine the
effectiveness of Wii balance therapy for the restoration of balance in patients
with stroke. The study population comprises 56 patients with a cerebrovascular
accident (CVA), which are randomized over the intervention (= Wii balance
therapy) and control (= conventional balance therapy) group. Measurements are
performed before and after the balance therapy. Patient's balance is measured
with the Berg balance scale and the dynamic gait index. Activities of daily
living, participation and quality of life are measured with respectively the
Barthel index, the Life Habits questionnaire and RAND36.
Intervention
The subjects receive balance training for 8 weeks. The intervention group will
exercise daily for 8 weeks with Wii-Fit: 2x per week 30 minutes under the
guidance of a physiotherapist, and on the other days 30 minutes at home. The
control group receives standard 8-week balance training for patients with
stroke: 2x per week under the guidance of a physiotherapist, and on the other
days 1x per day for 30 minutes at home.
Study burden and risks
The risks associated with this study are minimal. There is a slight physical
load when performing the Wii balance exercises, however, this corresponds with
the physical load of the standard balance therapy.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Patients with a stroke, longer than 6 weeks and shorter than 6 months,
diagnosed by a neurologist
- Minimal age of 18 years
- Sum score < 56 points on Berg Balance scale
- can be instructed to perform simple tasks
- Written Informed Consent
Exclusion criteria
- A medical history of neurological disorders, other than mentioned in the inclusion criteria
- Musculoskeletal disorders that influence the lower extremities
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 | NL29213.078.09 |