Impaired Balance in ElderlyPhase 1/2AdvanStepNCT01059253
Pilot Study of AdvanStep in Improving Balance in at Risk Elderly
A Phase 1/2 study testing AdvanStep training program - Turtle Pop in people with Impaired Balance in Elderly, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Balance in Elderly
- What is being tested?
- AdvanStep training program - Turtle Pop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Jun 2011
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-80
- History of 2 falls in past 5 years, not requiring medical attention
- No acute orthopedic or neurological disorders
- No cognitive impairment affecting daily function.
- Adequate vision and hearing to see the computer screen and follow verbal commands.
- Unilateral stance test - inability to remain in unilateral stance for 25 seconds
Who cannot join
- Congestive heart failure or angina that limits physical activity
- Need for interventional medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls
Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.
Read the detailed description
- Feasibility study, assessing usability of the system and receiving feedback from the volunteers.
- Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.
- Reassessment of balance and mobility after completion of 15 treatment sessions.
- Treatment sessions will be supervised by physical therapists.
- Conditions
- Impaired Balance in Elderly
- Being tested
- AdvanStep training program - Turtle Pop
- Keywords
- Falls, Balance, Elderly, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvanStep training program - Turtle PopOther
Also called AdvanStep Contoller p/n fg00002 rev. A1, Turtle Pop p/n gw00005 rev. A1
Balance / mobility exercise program using the AdvanStep in a virtual reality context
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 15 training sessions Receives: Other: AdvanStep training program - Turtle Pop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test
Measured: On completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: equipment not functional
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Balance in ElderlyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Harold Weingarden, M.D., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059253
- Sponsor's protocol ID
- SHEBA-09-7170-HW-CTIL
- Acronym
- AdvanStep
- Status last verified
- Jun 2012
- First submitted
- 28 Jan 2010
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls
- ClinicalTrials.gov ID
- NCT01059253
- Acronym / sponsor ID
- AdvanStep / SHEBA-09-7170-HW-CTIL
- Conditions
- Impaired Balance in Elderly
- Keywords
- Falls, Balance, Elderly, Aged
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: equipment not functional
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Jan 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.
Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.
Detailed description
- Feasibility study, assessing usability of the system and receiving feedback from the volunteers.
- Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.
- Reassessment of balance and mobility after completion of 15 treatment sessions.
- Treatment sessions will be supervised by physical therapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: AdvanStep training program - Turtle Pop15 training sessions |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65-80
- History of 2 falls in past 5 years, not requiring medical attention
- No acute orthopedic or neurological disorders
- No cognitive impairment affecting daily function.
- Adequate vision and hearing to see the computer screen and follow verbal commands.
Key exclusion criteria (2 listed)
- Congestive heart failure or angina that limits physical activity
- Need for interventional medical treatment
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 |
|---|---|---|
| AdvanStep training program - Turtle PopAlso: AdvanStep Contoller p/n fg00002 rev. A1, Turtle Pop p/n gw00005 rev. A1Balance / mobility exercise program using the AdvanStep in a virtual reality context | Other | Training |
Primary outcome
Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test
Time frame: On completion of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
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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.
Harold Weingarden, M.D. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AdvanStep training program - Turtle Pop in people with Impaired Balance in Elderly, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 15 Jun 2012. 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 Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test (time frame: On completion of treatment). 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 15 Jun 2012.