Trial Outcomes & Findings for ActiveStep Comparative Effectiveness Trial (NCT NCT01006967)

NCT ID: NCT01006967

Last Updated: 2018-07-16

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

506 participants

Primary outcome timeframe

3 months

Results posted on

2018-07-16

Participant Flow

Participant milestones

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

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 months

Outcome measures

Outcome 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 months

Outcome measures

Outcome 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 Treatment

Outcome measures

Outcome 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 Treatment

The 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

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 Treatment

The 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

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 Treatment

The 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 13 deaths

Standard Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

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

Phone: 603 653-3575

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place