Trial Outcomes & Findings for Randomized ActiveStep Clinical Evaluation (NCT NCT00810082)

Results Overview

Subjects who had at least one fall subsequent to treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

3 months

Results posted on

2018-05-23

Patients were recruited from two sites, each a physical therapy clinic in a hospital setting.

Participant milestones
Measure	Standard Physical Therapy Only Physical therapy for fall prevention according to the clinician's standard practice.	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.
Overall Study STARTED	34	31
Overall Study COMPLETED	34	27
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal
Measure	Standard Physical Therapy Only Physical therapy for fall prevention according to the clinician's standard practice.	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.
Overall Study Lost to Follow-up	0	4

Randomized ActiveStep Clinical Evaluation

Baseline characteristics by cohort
Measure	Standard Physical Therapy Only n=34 Participants Physical therapy for fall prevention according to the clinician's standard practice.	Physical Therapy Incuding ActiveStep n=31 Participants 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.	Total n=65 Participants Total of all reporting groups
Age, Continuous	79.2 years STANDARD_DEVIATION 7.65 • n=5 Participants	81.1 years STANDARD_DEVIATION 7.53 • n=7 Participants	80.5 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	31 participants n=7 Participants	65 participants n=5 Participants

Timeframe: 3 months

Subjects who had at least one fall subsequent to treatment.

Outcome measures
Measure	Standard Physical Therapy Only n=34 Participants Physical therapy for fall prevention according to the clinician's standard practice.	Physical Therapy Incuding ActiveStep n=27 Participants 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.
Participants With at Least One Fall	11 participants	5 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Dartmouth College

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