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Trial record 1 of 1 for:    NCT01006967
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ActiveStep Comparative Effectiveness Trial (RACE)

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ClinicalTrials.gov Identifier: NCT01006967
Recruitment Status : Completed
First Posted : November 3, 2009
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jon D. Lurie, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Gait Disorders
Interventions Device: ActiveStep Treadmill
Other: Physical Therapy
Enrollment 506
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ActiveStep Standard Physical Therapy
Hide Arm/Group Description

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.

Subjects will receive a standard physical therapy program for gait and balance.

Physical Therapy: Standard program of physical therapy for gait and balance

Period Title: Overall Study
Started 253 253
Received Treatment 245 245
3 Month Follow-up 212 210
Completed 187 190
Not Completed 66 63
Arm/Group Title ActiveStep Standard Physical Therapy Total
Hide Arm/Group Description

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.

Subjects will receive a standard physical therapy program for gait and balance.

Physical Therapy: Standard program of physical therapy for gait and balance

Total of all reporting groups
Overall Number of Baseline Participants 253 253 506
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 253 participants 253 participants 506 participants
78
(65 to 96)
78
(65 to 95)
78
(65 to 96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 253 participants 506 participants
Female
119
  47.0%
119
  47.0%
238
  47.0%
Male
134
  53.0%
134
  53.0%
268
  53.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Fall in past 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 253 participants 506 participants
136
  53.8%
130
  51.4%
266
  52.6%
Fall in Past Year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 253 participants 506 participants
179
  70.8%
169
  66.8%
348
  68.8%
1.Primary Outcome
Title Number of Subjects Reporting Any Fall
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Physical Therapy
Hide Arm/Group Description:

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.

Subjects will receive a standard physical therapy program for gait and balance.

Physical Therapy: Standard program of physical therapy for gait and balance

Overall Number of Participants Analyzed 212 210
Measure Type: Count of Participants
Unit of Measure: Participants
60
  28.3%
77
  36.7%
2.Primary Outcome
Title Number of Subjects Reporting a Fall-related Injury
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Physical Therapy
Hide Arm/Group Description:

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.

Subjects will receive a standard physical therapy program for gait and balance.

Physical Therapy: Standard program of physical therapy for gait and balance

Overall Number of Participants Analyzed 212 210
Measure Type: Count of Participants
Unit of Measure: Participants
12
   5.7%
28
  13.3%
3.Secondary Outcome
Title Change in Timed Up and Go From Baseline
Hide Description [Not Specified]
Time Frame End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 149 153
Mean (Standard Deviation)
Unit of Measure: seconds
-1.96  (318) -2.18  (3.86)
4.Secondary Outcome
Title Change in Berg Balance Scale From Baseline
Hide Description 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.
Time Frame End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 175 180
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.96  (5.17) 5.79  (5.22)
5.Secondary Outcome
Title Change in Dynamic Gait Index From Baseline
Hide Description 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.
Time Frame End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 172 177
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.26  (5.7) 3.74  (3.37)
6.Secondary Outcome
Title Change in Activities-specific Balance Confidence From Baseline
Hide Description 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.
Time Frame End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ActiveStep Standard Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 177 168
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.05  (16.08) 12.05  (17.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ActiveStep Standard Treatment
Hide Arm/Group Description Activestep Group Standard Treatment Group
All-Cause Mortality
ActiveStep Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   13/245 (5.31%)   6/245 (2.45%) 
Show Serious Adverse Events Hide Serious Adverse Events
ActiveStep Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/245 (0.00%)   0/245 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ActiveStep Standard Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/245 (0.00%)   0/245 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jon D. Lurie, MD, MS
Organization: Geisel School of Medicine at Dartmouth
Phone: 603 653-3575
Responsible Party: Jon D. Lurie, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01006967     History of Changes
Other Study ID Numbers: AHRQ R18 HS18459
First Submitted: October 27, 2009
First Posted: November 3, 2009
Results First Submitted: April 5, 2018
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018