Condition category
Signs and Symptoms
Date applied
24/10/2008
Date assigned
26/11/2008
Last edited
26/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ibws.ethz.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes