NCT02077049

Brief Summary

The main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Secondly the study explores to which extend balance and mobility performances vary according to the mode of self-training. The primary study hypothesis is that elderly people practice longer and more frequently with serious games than with a conventional exercise booklet. The secondary hypothesis is that patients experience a significant higher improvement in their balance capacity by using serious games compared to patients performing conventional exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

February 6, 2014

Last Update Submit

February 27, 2019

Conditions

Keywords

elderlyexercise programself-trainingmobilitycomputer-based learning gamesserious gamebalancetraining adherencetraining complianceKinect ®Fit Bit ®

Outcome Measures

Primary Outcomes (1)

  • Intensity of self-training

    Self-training intensity is defined as the frequency of training sessions (f) multiplied by the duration (T) of each training session. The training intensity (f x T) of the 10-days intervention are summated. These data are recorded daily in a logbook by the patient himself from t1 (which equates to approximately day 4 after admission) till the end of the intervention (t2) i.e. 10 workings days later. The logbook is then collected for data extraction at the end of the intervention (t2), which equates to approximately day 16-17 after patient's admission in the clinic.

    The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days.

Secondary Outcomes (3)

  • Berg Balance Scale

    The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days

  • Falls Efficacy Scale - International version

    The questionnaire is completed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days

  • Local dynamic stability

    The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days.

Study Arms (2)

serious games self-training program

EXPERIMENTAL

Serious games are played, using Kinect® and Fit Bit®. This program is performed during the 10 days of the intervention on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program.

Device: serious games

Conventional self-training program

ACTIVE COMPARATOR

conventional physical exercises are performed during the 10 days of the intervention, on a self-training basis and 2 specific time-slot (2x30 min) per day are allocated for this program.

Other: Conventional self-training

Interventions

Execution of computer-based games that stimulate patient's mobility. The game is displayed on a Television (TV) screen and the patient's movements are detected by the sensors of the Kinect® camera, requiring therefore no game console. The Fit Bit®, a mobility tracker device, is attached at the patient's belt the whole day and measure all the trips performed and stairs climbed. This serious games program is instructed individually by experienced physiotherapists.

Also known as: Kinect®, Xbox®, Windows®, Fit Bit®
serious games self-training program

Participants perform conventional physical exercises that train their balance capabilities. There are instructed by experienced physiotherapists and are adapted to each patient's physical abilities. Detailed handouts are distributed to each participants.

Also known as: gymnastic exercises, home exercises, physical exercises
Conventional self-training program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • +65 years old
  • Ability to walk independently over 20meters, with or without walking aids.
  • Self-training prescribed by the doctor
  • sufficient written and spoken knowledge of German to fill out questionnaires, with or without help.
  • Informed consent

You may not qualify if:

  • Cognitive impairment, defined as a Mini-Mental-State Examination (MMSE) score \< 26.
  • Other limiting disorders hampering the practice of computer-based games (e.g. visual impairment, numbness, vertigo)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walenstadtberg Klinik

Walenstadtberg, Canton of St. Gallen, 8881, Switzerland

Location

Related Publications (7)

  • Schnurr B, & Oesch P. Sind Nintendo Wii-Balancespiele eine machbare Alternative zum herkömmlichen Selbsttraining des Gleichgewichts nach Schlaganfall? Ergoscience (4): 147-156, 2012.

    BACKGROUND
  • Bachmann S, Finger C, Huss A, Egger M, Stuck AE, Clough-Gorr KM. Inpatient rehabilitation specifically designed for geriatric patients: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010 Apr 20;340:c1718. doi: 10.1136/bmj.c1718.

    PMID: 20406866BACKGROUND
  • Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/

    PMID: 26180873BACKGROUND
  • Phillips EM, Schneider JC, Mercer GR. Motivating elders to initiate and maintain exercise. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S52-7; quiz S58-9. doi: 10.1016/j.apmr.2004.03.012.

    PMID: 15221728BACKGROUND
  • Olney SJ, Nymark J, Brouwer B, Culham E, Day A, Heard J, Henderson M, Parvataneni K. A randomized controlled trial of supervised versus unsupervised exercise programs for ambulatory stroke survivors. Stroke. 2006 Feb;37(2):476-81. doi: 10.1161/01.STR.0000199061.85897.b7. Epub 2006 Jan 12.

    PMID: 16410482BACKGROUND
  • Oesch P, Kool J, Fernandez-Luque L, Brox E, Evertsen G, Civit A, Hilfiker R, Bachmann S. Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial. BMC Geriatr. 2017 Mar 23;17(1):77. doi: 10.1186/s12877-017-0467-7.

  • Hasselmann V, Oesch P, Fernandez-Luque L, Bachmann S. Are exergames promoting mobility an attractive alternative to conventional self-regulated exercises for elderly people in a rehabilitation setting? Study protocol of a randomized controlled trial. BMC Geriatr. 2015 Sep 7;15:108. doi: 10.1186/s12877-015-0106-0.

MeSH Terms

Conditions

Mobility Limitation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter Oesch, PhD PT

    Kliniken Valens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PT

Study Record Dates

First Submitted

February 6, 2014

First Posted

March 4, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations