Fall PreventionRACENCT00810082
Randomized ActiveStep Clinical Evaluation
A study testing ActiveStep and Standard Physical Therapy for Fall Prevention in people with Fall Prevention, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Prevention
- What is being tested?
- ActiveStep and Standard Physical Therapy for Fall Prevention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or older
- Referred for balance training
Who cannot join
- Age < 65
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Alice Peck Day Memorial Hospital
Lebanon, New Hampshire, 03766
About this study
The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.
- Conditions
- Fall Prevention
- Being tested
- ActiveStep, Standard Physical Therapy for Fall Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveStepDevice
ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.
Standard Physical Therapy for Fall PreventionOther
Standard physical therapy for fall prevention
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Standard physical therapy for fall prevention Receives: Other: Standard Physical Therapy for Fall Prevention |
| Group B | Experimental | Physical therapy for fall prevention that includes ActiveStep Receives: Device: ActiveStep; Other: Standard Physical Therapy for Fall Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With at Least One Fall
Subjects who had at least one fall subsequent to treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon D Lurie, MD, MS, Principal investigator, Dartmouth CollegeRichard M Greenwald, PhD, Principal investigator, Simbex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810082
- Sponsor's protocol ID
- TDI001
- Acronym
- RACE
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2008
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized ActiveStep Clinical Evaluation
- ClinicalTrials.gov ID
- NCT00810082
- Acronym / sponsor ID
- RACE / TDI001
- Conditions
- Fall Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Standard Physical Therapy for Fall PreventionStandard physical therapy for fall prevention |
| Group B | Experimental | Device: ActiveStep, Other: Standard Physical Therapy for Fall PreventionPhysical therapy for fall prevention that includes ActiveStep |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 or older
- Referred for balance training
Key exclusion criteria (1 listed)
- Age < 65
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 |
|---|---|---|
| ActiveStepActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment. | Device | Group B |
| Standard Physical Therapy for Fall PreventionStandard physical therapy for fall prevention | Other | Group A, Group B |
Primary outcome
Participants With at Least One Fall
Time frame: 3 months
Subjects who had at least one fall subsequent to treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jon D Lurie, MD, MS principal investigator
Dartmouth College
Richard M Greenwald, PhD principal investigator
Simbex Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveStep and Standard Physical Therapy for Fall Prevention in people with Fall Prevention, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
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 2 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 23 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 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With at Least One Fall (time frame: 3 months). 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 23 May 2018.