Contact information
Type
Scientific
Primary contact
Dr Eling D de Bruin
ORCID ID
Contact details
Institute of Human Movement Sciences and Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zurich
CH-8093 Zürich
Switzerland
+41 44 632 40 18
debruin@move.biol.ethz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Training control of bodily orientation as a function of attentional focus in older adults
Acronym
Study hypothesis
Individuals that receive an external focus (EF) instruction during training of dynamic balance skills will show different development of their balance ability compared to individuals that receive an internal focus (IF) instruction.
Ethics approval
The study was approved by the Ethics Committee of the Canton of Zurich on the 10/10/2006 (ref: EK 19/2006 [ETH])
Study design
Randomised single-blind controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Postural balance skills in elderly
Intervention
Balance assessment and training on a Biodex Stability System (BSS) (Biodex Medical Systems Inc., USA) device under two different verbal instruction conditions.
Participants in both groups were instructed to focus on the visual feedback screen whilst performing their exercises. The screen showed a moving point in the middle of a target and the participants were asked to follow the target through shifting their weight. All participants received an exercise protocol in which the exercises gradually became more complex.
The IF group participants were, prior to IF trials, instructed with the feedback that the moving point on the feedback screen represented their body centre of gravity. They were instructed to focus on this centre through concentrating on their belly (while looking straight ahead at the video screen) and to volitionally move this point on the screen through exertion of force on this imaginary point.
The EF group participants were instructed that the moving point on the feedback screen represented an air bubble in a level, (as used in the building industry to determine a level horizontal line), positioned in front of the feet of the participant standing on the plate. Such a level was attached to the platform with an electronic cable, thus suggesting a direct connection between movements of the air bubble in the level and the marker on the screen. The EF participants had to focus on the air bubble (while looking straight ahead at the video screen) and try to consciously move this bubble in the level.
All participants were expected to perform at least three practice trials per exercise on two week days for five consecutive weeks under the treatment conditions. Before every practice trial, participants were given short reminders to focus on the respective 'moving points'. In a fourth trial, the time needed to perform the exercise under test conditions was measured together with the Dynamic Stability Index of the participants. This procedure was chosen to rule out short-term learning effects. Training duration lasted between 25 and 35 minutes.
In order to avoid bias, the information that focus of attention of the participants possibly plays an important role in the speed of learning was not disclosed before training commenced. Following the five weeks training programme, complete information on the aim of the study was given to each participant in a debriefing session. The reason for not disclosing this information before the measurements was discussed at the debriefing. Only the results of participants who agreed with this procedure were included in the final data analysis.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The following were measured in each training session:
1. The weight shift score for medio-lateral movements on the stable BSS platform
2. Performance time on the unstable BSS platform for the dynamic limits of stability (LOS) test and the dynamic stability index derived from this test
Secondary outcome measures
The following were assessed at baseline (pre-training) and after completion of 10 training sessions (post-training):
1. The Expanded Timed Get-up-and-Go (ETGUG) test. Times for the component tasks are measured using a multi-memory stopwatch.
2. The time for 5 consecutive chair rises without the use of hands
3. The Falls Efficacy Scale International (FES-I) questionnaire as a measure of 'concern' about falling
Overall trial start date
01/11/2006
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, 70 years of age and older
2. Assisted living
3. Ability to see a feedback marker on a computer screen
4. A score of 25 or more in the Mini Mental Status Examination (MMSE)
5. Ability to be able to follow verbal instructions in the German language and the ability to stand upright independently
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. A rapidly progressive or terminal illness
2. Acute illness or unstable chronic illness
3. Those who were undergoing balance training at the time of enrolment or had prior experience with the training task
Recruitment start date
01/11/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Switzerland
Trial participating centre
Institute of Human Movement Sciences and Sport
Zurich
CH-8093 Zürich
Switzerland
Sponsor information
Organisation
Swiss Federal Institute of Technology Zürich (ETH Zürich) (Switzerland)
Sponsor details
Institute of Human Movement Sciences and Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zurich
CH-8093
Switzerland
+41 44 632 40 18
debruin@move.biol.ethz.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Swiss Federal Institute of Technology Zürich (ETH Zürich) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list