Below Knee AmputationNCT01131819
Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program
A study testing Nintendo Wii fit ™ balance board in people with Below Knee Amputation, run by University of British Columbia at 1 site in Canada.
Trial summary
Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Below Knee Amputation
- What is being tested?
- Nintendo Wii fit ™ balance board
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Sep 2012
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consented subjects with new, unilateral, transtibial amputations who are greater than 19 years of age
Who cannot join
- Subjects who have an open wound that limits their wearing of the prosthesis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rehab Research Lab, GF Strong Rehab Centre
Vancouver, British Columbia, V5Z2G9
About this study
Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance.
Hypothesis: The investigators hypothesize that subjects will benefit from the use of the device and that this will manifest as an improvement on outcome measures.
Read the detailed description
All subjects will be trained by the same specialist physiotherapist. Subjects will use the Wii Fit balance platform for a period of twenty minutes or greater per day (at the discretion of the specialist physiotherapist) during their standard rehabilitation program. These balance training exercises will be in addition to those already used in the standard rehabilitation program, but will not add to the total therapy session time. Activities on the device will be chosen by the therapist based on the subjects' current abilities and their phase of training. More complicated tasks will be given as the subject progresses. The therapist will intervene and provide instruction / correction if the subject is using unsafe technique or poor technique (postures, positioning strategies that would not be condoned in the regular training program).
The device is a stable, level platform 5.5 cm from the floor. Subjects stand on the device and may use gait aids if indicated.
Standard practice involves intensive training of the subject by the same specialist physiotherapist but without the use of the Wii Fit platform.
- Conditions
- Below Knee Amputation
- Being tested
- Nintendo Wii fit ™ balance board
- Keywords
- Trans-tibial Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii fit ™ balance boardDevice
Nintendo Wii fit ™ balance board will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects for a minimum of 6 times in two weeks and a maximum of 18 times in 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | The novel intervention we propose to use, the Wii Fit, will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects in the study. Receives: Device: Nintendo Wii fit ™ balance board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) measures subject's ability to perform three tasks: standing balance, gait speed and lower extremity strength (chair stands). Collected at each data collection session
NeuroCom Clinical Research System
The NeuroCom Clinical Research System is a commercially available objective measure that is able to detect and document perturbations in balance in three (X, Y, Z components) planes in order to determine postural sway. The system consists of a dual platform that moves or does not move in conjunction with a visual surround. The Sensory Organization Test (SOT) will be used to test 3 sensory components of balance (visual, somatosensory and vestibular inputs) under 6 standard conditions. Collected at each data collection session.
Secondary outcomes (5)
Walking ability will be measured using the L-Test. This walk test incorporates a sit-to-stand component, turns to both the left and the right over a distance of 20 meters.
Collected at each data collection session
Walking endurance will be assessed using the 2 Minute Walk Test (2MWT). Starting from a standing position this test requires individuals to walk at a fast safe pace for a period of two minutes.
Collected at each data collection session
Balance confidence will be measured using the 16 item Activities-specific Balance Confidence (ABC Scale). The items assess the perceived confidence (self-efficacy) the individual has in performing an increasing complex series of tasks.
Collected at each data collection session
The Short Feedback Questionnaire-modified (SFQ-M) will be used to determine subjects' level of satisfaction with their rehabilitation program as well as with the interactive video game experience.
Collected at the end of the project
A 9-item Falls Diary will be kept by each subject documenting number of falls, circumstances (eg/ cause, location, assistive device used or not) and consequences (eg/ medical visit, injury) over the past week.
Collected weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Below Knee AmputationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C. Miller, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131819
- Sponsor's protocol ID
- H09-00523
- Status last verified
- May 2018
- First submitted
- 21 May 2010
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program
- ClinicalTrials.gov ID
- NCT01131819
- Acronym / sponsor ID
- H09-00523
- Conditions
- Below Knee Amputation
- Keywords
- Trans-tibial Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 May 2010 (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.
Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance.
Hypothesis: The investigators hypothesize that subjects will benefit from the use of the device and that this will manifest as an improvement on outcome measures.
Detailed description
All subjects will be trained by the same specialist physiotherapist. Subjects will use the Wii Fit balance platform for a period of twenty minutes or greater per day (at the discretion of the specialist physiotherapist) during their standard rehabilitation program. These balance training exercises will be in addition to those already used in the standard rehabilitation program, but will not add to the total therapy session time. Activities on the device will be chosen by the therapist based on the subjects' current abilities and their phase of training. More complicated tasks will be given as the subject progresses. The therapist will intervene and provide instruction / correction if the subject is using unsafe technique or poor technique (postures, positioning strategies that would not be condoned in the regular training program).
The device is a stable, level platform 5.5 cm from the floor. Subjects stand on the device and may use gait aids if indicated.
Standard practice involves intensive training of the subject by the same specialist physiotherapist but without the use of the Wii Fit platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Nintendo Wii fit ™ balance boardThe novel intervention we propose to use, the Wii Fit, will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects in the study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consented subjects with new, unilateral, transtibial amputations who are greater than 19 years of age
Key exclusion criteria (1 listed)
- Subjects who have an open wound that limits their wearing of the prosthesis
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 |
|---|---|---|
| Nintendo Wii fit ™ balance boardNintendo Wii fit ™ balance board will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects for a minimum of 6 times in two weeks and a maximum of 18 times in 6 weeks. | Device | 1 |
Primary outcome
Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) measures subject's ability to perform three tasks: standing balance, gait speed and lower extremity strength (chair stands). Collected at each data collection session
NeuroCom Clinical Research System
The NeuroCom Clinical Research System is a commercially available objective measure that is able to detect and document perturbations in balance in three (X, Y, Z components) planes in order to determine postural sway. The system consists of a dual platform that moves or does not move in conjunction with a visual surround. The Sensory Organization Test (SOT) will be used to test 3 sensory components of balance (visual, somatosensory and vestibular inputs) under 6 standard conditions. Collected at each data collection session.
5 secondary outcomes
Walking ability will be measured using the L-Test. This walk test incorporates a sit-to-stand component, turns to both the left and the right over a distance of 20 meters.
Walking endurance will be assessed using the 2 Minute Walk Test (2MWT). Starting from a standing position this test requires individuals to walk at a fast safe pace for a period of two minutes.
Balance confidence will be measured using the 16 item Activities-specific Balance Confidence (ABC Scale). The items assess the perceived confidence (self-efficacy) the individual has in performing an increasing complex series of tasks.
The Short Feedback Questionnaire-modified (SFQ-M) will be used to determine subjects' level of satisfaction with their rehabilitation program as well as with the interactive video game experience.
A 9-item Falls Diary will be kept by each subject documenting number of falls, circumstances (eg/ cause, location, assistive device used or not) and consequences (eg/ medical visit, injury) over the past week.
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 30 May 2018.
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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.
William C. Miller, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii fit ™ balance board in people with Below Knee Amputation, run by University of British Columbia 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 1 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 30 May 2018. 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.
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?
Short Physical Performance Battery. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.