Fall Prevention
Conditions
Brief 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.
Interventions
DEVICEActiveStep
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.
OTHERStandard Physical Therapy for Fall Prevention
Standard physical therapy for fall prevention
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 or older * Referred for balance training
Exclusion criteria
* Age \< 65
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With at Least One Fall | 3 months | Subjects who had at least one fall subsequent to treatment. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from two sites, each a physical therapy clinic in a hospital setting.
Participants by arm
| Arm | Count |
|---|---|
| Standard Physical Therapy Only Physical therapy for fall prevention according to the clinician's standard practice. | 34 |
| 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. | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
Baseline characteristics
| Characteristic | Standard Physical Therapy Only | Physical Therapy Incuding ActiveStep | Total |
|---|---|---|---|
| Age, Continuous | 79.2 years STANDARD_DEVIATION 7.65 | 81.1 years STANDARD_DEVIATION 7.53 | 80.5 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 34 participants | 31 participants | 65 participants |
| Sex: Female, Male Female | 23 Participants | 14 Participants | 37 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 31 |
| serious Total, serious adverse events | 0 / 34 | 0 / 31 |
Outcome results
Primary
Participants With at Least One Fall
Subjects who had at least one fall subsequent to treatment.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Physical Therapy Only | Participants With at Least One Fall | 11 participants |
| Physical Therapy Incuding ActiveStep | Participants With at Least One Fall | 5 participants |