ISRCTN ISRCTN44627088
DOI https://doi.org/10.1186/ISRCTN44627088
Secondary identifying numbers N/A
Submission date
24/10/2008
Registration date
26/11/2008
Last edited
26/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eling D de Bruin
Scientific

Institute of Human Movement Sciences and Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zurich
CH-8093 Zürich
Switzerland

Phone +41 44 632 40 18
Email debruin@move.biol.ethz.ch

Study information

Study designRandomised single-blind controlled multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleTraining control of bodily orientation as a function of attentional focus in older adults
Study objectivesIndividuals 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(s)The study was approved by the Ethics Committee of the Canton of Zurich on the 10/10/2006 (ref: EK 19/2006 [ETH])
Health condition(s) or problem(s) studiedPostural balance skills in elderly
InterventionBalance 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 typeOther
Primary outcome measureThe 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 measuresThe 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 study start date01/11/2006
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2006
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Institute of Human Movement Sciences and Sport
Zurich
CH-8093 Zürich
Switzerland

Sponsor information

Swiss Federal Institute of Technology Zürich (ETH Zürich) (Switzerland)
University/education

Institute of Human Movement Sciences and Sport
HIT J 32.3
Wolfgang-Pauli-Str. 27
Zurich
CH-8093
Switzerland

Phone +41 44 632 40 18
Email debruin@move.biol.ethz.ch
Website http://www.ibws.ethz.ch
ROR logo "ROR" https://ror.org/05a28rw58

Funders

Funder type

University/education

Swiss Federal Institute of Technology Zürich (ETH Zürich) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan