Trial Outcomes & Findings for ActiveStep Comparative Effectiveness Trial (NCT NCT01006967)
NCT ID: NCT01006967
Last Updated: 2018-07-16
Results Overview
COMPLETED
NA
506 participants
3 months
2018-07-16
Participant Flow
Participant milestones
| Measure |
ActiveStep
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
253
|
|
Overall Study
Received Treatment
|
245
|
245
|
|
Overall Study
3 Month Follow-up
|
212
|
210
|
|
Overall Study
COMPLETED
|
187
|
190
|
|
Overall Study
NOT COMPLETED
|
66
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ActiveStep
n=253 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=253 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
n=253 Participants
|
78 years
n=253 Participants
|
78 years
n=506 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=253 Participants
|
119 Participants
n=253 Participants
|
238 Participants
n=506 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=253 Participants
|
134 Participants
n=253 Participants
|
268 Participants
n=506 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Fall in past 3 months
|
136 Participants
n=253 Participants
|
130 Participants
n=253 Participants
|
266 Participants
n=506 Participants
|
|
Fall in Past Year
|
179 Participants
n=253 Participants
|
169 Participants
n=253 Participants
|
348 Participants
n=506 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
ActiveStep
n=212 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=210 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Number of Subjects Reporting Any Fall
|
60 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
ActiveStep
n=212 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=210 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Number of Subjects Reporting a Fall-related Injury
|
12 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: End of TreatmentOutcome measures
| Measure |
ActiveStep
n=149 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=153 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Change in Timed Up and Go From Baseline
|
-1.96 seconds
Standard Deviation 318
|
-2.18 seconds
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: End of TreatmentThe Berg Balance Measure (Berg) was designed to test an elderly patient's level of balance. The test consists of 14 balance items that have been deemed safe for elderly patients to perform. The Berg is a task performance exam that takes about 15 to 20 minutes to complete. The test is scored while it is administered. Each of the independent items are scored on a five point ordinal scale where 0 indicates the patient's inability to perform the task and 4 represents independence; the individual points are then summed to achieve a total score (range 0 - 56). The higher the patient's score on the Berg the more independent the patient. The reported outcome is the change in the Berg between baseline and end of treatment.
Outcome measures
| Measure |
ActiveStep
n=175 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=180 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Change in Berg Balance Scale From Baseline
|
5.96 units on a scale
Standard Deviation 5.17
|
5.79 units on a scale
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: End of TreatmentThe Dynamic Gait Index (DGI) is another instrument that was developed to assess the likelihood of falling in older adults and tests eight facets of gait. The DGI takes about 15 minutes and requires the following equipment: a Box (Shoebox); 2 Cones; Stairs; and a 20' walkway that is 15" wide. Each item is scored on a four-point ordinal scale, ranging from 0-3 where "0" indicates the lowest level of function and "3" the highest level of function, resulting in a total score of 0 to 24. The interpretation guidelines state that a score \< 19/24 is predictive of falls in the elderly while as score of \> 22/24 indicate safe walkers. The outcome reported is the change in the DGI between baseline and end-of-treatment.
Outcome measures
| Measure |
ActiveStep
n=172 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=177 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Change in Dynamic Gait Index From Baseline
|
3.26 units on a scale
Standard Deviation 5.7
|
3.74 units on a scale
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: End of TreatmentThe Activity-specific Balance Confidence scale (ABC) is a patient self-report measure tthat measures the subject's self-assessed confidence in being able to perform 16 specific activities without losing their balance or becoming unsteady. For each task (i.e. walking around the house, sweeping the floor, walking outside on an icy sidewalk) the subject indicates their level of confidence in doing the activity without losing their balance. For items the subject does not normally perform, they are asked to try and imagine how confident they would feel if they had to do the activity. For subjects who normally use a walking aid to do the specific activity, they are asked to rate their confidence as if they were using these supports. Each item is rated 0-100 for each item. To obtain the final score, the ratings are averaged across the 16 items to produce an overall score from 0-100 with higher scores indicated greater balance confidence.
Outcome measures
| Measure |
ActiveStep
n=177 Participants
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
ActiveStep Treadmill: The ActiveStep treadmill is a device that trains patients to effectively react to simulated slips and trips while the patient is safely held in a harness.
|
Standard Physical Therapy
n=168 Participants
Subjects will receive a standard physical therapy program for gait and balance.
Physical Therapy: Standard program of physical therapy for gait and balance
|
|---|---|---|
|
Change in Activities-specific Balance Confidence From Baseline
|
11.05 units on a scale
Standard Deviation 16.08
|
12.05 units on a scale
Standard Deviation 17.29
|
Adverse Events
ActiveStep
Standard Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jon D. Lurie, MD, MS
Geisel School of Medicine at Dartmouth
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place