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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Standard physical therapy for fall prevention |
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| Group B | Experimental | Physical therapy for fall prevention that includes ActiveStep |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveStep | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With at Least One Fall | Subjects who had at least one fall subsequent to treatment. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon D Lurie, MD, MS | Dartmouth College | Principal Investigator |
| Richard M Greenwald, PhD | Simbex Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| Alice Peck Day Memorial Hospital |
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Patients were recruited from two sites, each a physical therapy clinic in a hospital setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Physical Therapy Only | Physical therapy for fall prevention according to the clinician's standard practice. |
| FG001 | Physical Therapy Incuding ActiveStep | Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Physical Therapy Only | Physical therapy for fall prevention according to the clinician's standard practice. |
| BG001 | Physical Therapy Incuding ActiveStep | Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With at Least One Fall | Subjects who had at least one fall subsequent to treatment. | Posted | Number | participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Physical Therapy Only | Physical therapy for fall prevention according to the clinician's standard practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon D. Lurie, MD, MS | Dartmouth College | 603-653-3575 | Jonathan D. Lurie <Jonathan.D.Lurie@hitchcock.org> |
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| Standard Physical Therapy for Fall Prevention | Other | Standard physical therapy for fall prevention |
|
| Lebanon |
| New Hampshire |
| 03766 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Physical Therapy Incuding ActiveStep | Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling. | 0 | 31 | 0 | 31 |
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