Mobility LimitationPhase 2NCT01381237
Effects of Game-based Balance Exercise for Older Adults With Fall History
A Phase 2 study testing game-based balance exercises in people with Mobility Limitation, run by University of Manitoba at 1 site in Canada.
Trial summary
Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- game-based balance exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age: 65-85 years
- Mini-Mental State Examination (MMSE) score > 24
- English-speaking with the ability to understand the nature of the study and provide informed consent
- independent in ambulatory functions, with or without an assistive device (cane or walker).
Who cannot join
- any medical condition or disability that prevented participation in an exercise program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full Title Interactive Computer Game Exercise Regime, Effects on Balance Impairment in Frail Community-Dwelling Older Adults. A Randomized Controlled Trial
Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. The purpose was to examine effects of physical therapy based on the task-oriented approach delivered in an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Thirty community dwelling and ambulatory older adults attending the Day hospital for balance and mobility limitation treatment participated in this study. Participants were randomly assigned to either a control group or experimental group. The control group received the typical rehabilitation program provided at the Day Hospital, consisting of strengthening and balance exercises. The experimental group received a program of dynamic balance exercises coupled to video game play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface with progression to a compliant sponge pad. Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance performance measures and spatial-temporal gait variables were obtained pre- and post-treatment Findings demonstrated significant improvements for both groups in balance performance scores post-treatment, and change scores were significantly greater in the experimental compared to control group. No significant treatment effect was observed in either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This in turn resulted in a greater improvement in dynamic standing balance control compared to the typical exercise program. However there was no transfer of effect to gait function.
Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center of Pressure.
- Conditions
- Mobility Limitation
- Being tested
- game-based balance exercises
- Keywords
- Balance, Postural, Rehabilitation, Therapy, computer-assisted, Video Games, Center of Pressure
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
game-based balance exercisesBehavioural
16 sessions, scheduled two per week, each lasting 45 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standing Balance
timed performance and ordinal scales
Measured: 5 weeks
Secondary outcomes (2)
Gait speed
Measured: 5 weeks
Spatial-temporal gait variables
distance and time
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Tony Szturm, BSc(PT), PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381237
- Sponsor's protocol ID
- H2007-047
- Status last verified
- Mar 2007
- First submitted
- 20 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.
PubMed 21799138
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Title Interactive Computer Game Exercise Regime, Effects on Balance Impairment in Frail Community-Dwelling Older Adults. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01381237
- Acronym / sponsor ID
- H2007-047
- Conditions
- Mobility Limitation
- Keywords
- Balance, Postural, Rehabilitation, Therapy, computer-assisted, Video Games, Center of Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. The purpose was to examine effects of physical therapy based on the task-oriented approach delivered in an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Thirty community dwelling and ambulatory older adults attending the Day hospital for balance and mobility limitation treatment participated in this study. Participants were randomly assigned to either a control group or experimental group. The control group received the typical rehabilitation program provided at the Day Hospital, consisting of strengthening and balance exercises. The experimental group received a program of dynamic balance exercises coupled to video game play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface with progression to a compliant sponge pad. Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance performance measures and spatial-temporal gait variables were obtained pre- and post-treatment Findings demonstrated significant improvements for both groups in balance performance scores post-treatment, and change scores were significantly greater in the experimental compared to control group. No significant treatment effect was observed in either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This in turn resulted in a greater improvement in dynamic standing balance control compared to the typical exercise program. However there was no transfer of effect to gait function.
Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center of Pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age: 65-85 years
- Mini-Mental State Examination (MMSE) score > 24
- English-speaking with the ability to understand the nature of the study and provide informed consent
- independent in ambulatory functions, with or without an assistive device (cane or walker).
Key exclusion criteria (1 listed)
- any medical condition or disability that prevented participation in an exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| game-based balance exercises16 sessions, scheduled two per week, each lasting 45 minutes. | Behavioural | – |
Primary outcome
Standing Balance
Time frame: 5 weeks
timed performance and ordinal scales
2 secondary outcomes
Gait speed
Time frame: 5 weeks
Spatial-temporal gait variables
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Derived from this study: PubMed 21799138Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.
Related trials for Mobility Limitation
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Szturm, BSc(PT), PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing game-based balance exercises in people with Mobility Limitation, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standing Balance (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.