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
The investigators are conducting a multi-center randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.
Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.
|Condition or disease||Intervention/treatment||Phase|
|Gait Disorders||Device: ActiveStep Treadmill Other: Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized ActiveStep Comparative Effectiveness Trial|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2016|
Active Comparator: ActiveStep
Subjects will use the ActiveStep treadmill as part of their physical therapy program for balance
Device: 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.
Active Comparator: Standard physical therapy
Subjects will receive a standard physical therapy program for gait and balance.
Other: Physical Therapy
Standard program of physical therapy for gait and balance
- Number of Subjects Reporting Any Fall [ Time Frame: 3 months ]
- Number of Subjects Reporting a Fall-related Injury [ Time Frame: 3 months ]
- Change in Timed Up and Go From Baseline [ Time Frame: End of Treatment ]
- Change in Berg Balance Scale From Baseline [ Time Frame: 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.
- Change in Dynamic Gait Index From Baseline [ Time Frame: 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.
- Change in Activities-specific Balance Confidence From Baseline [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006967
|United States, Massachusetts|
|Newton, Massachusetts, United States, 02462|
|Spaulding Rehabilitation Hospital|
|Salem, Massachusetts, United States, 01970|
|United States, New Hampshire|
|Concord Hospital Rehabilitation Services|
|Epsom, New Hampshire, United States, 03234|
|Cheshire Medical Center - Farnum Rehabilitation Center|
|Keene, New Hampshire, United States, 03431|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|The Elliot Hospital|
|Manchester, New Hampshire, United States, 03104|
|United States, New York|
|South Shore Neurological Associates|
|Patchogue, New York, United States, 11722|
|United States, Vermont|
|White River Junction Veterans Administration Medical Center|
|White River Junction, Vermont, United States, 05009|
|Principal Investigator:||Jon D Lurie, M.D., M.S.||Dartmouth College|