RACE: Randomized ActiveStep Clinical Evaluation

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00810082
• Collaborator: (none)
• Enrollment: 65
• Locations: 2
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 32.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.

Condition or Disease	Intervention/Treatment	Phase
Fall Prevention	Device: ActiveStep; Other: Standard Physical Therapy for Fall Prevention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized ActiveStep Clinical Evaluation
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Standard physical therapy for fall prevention	Other: Standard Physical Therapy for Fall Prevention; Standard physical therapy for fall prevention
Experimental: Group B Physical therapy for fall prevention that includes ActiveStep	Device: ActiveStep; ActiveStep™ is a training simulator. The system uses a computer-controlled treadmill to recreate life-like dynamic balance challenges such as slipping and tripping in a safe, controlled environment.; Other: Standard Physical Therapy for Fall Prevention; Standard physical therapy for fall prevention

Outcome Measures

Primary Outcome Measures

1. Participants With at Least One Fall [3 months]

   Subjects who had at least one fall subsequent to treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 65 or older

• Referred for balance training

Exclusion Criteria:

• Age < 65

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
2	Alice Peck Day Memorial Hospital	Lebanon	New Hampshire	United States	03766

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Jon D Lurie, MD, MS, Dartmouth College
• Principal Investigator: Richard M Greenwald, PhD, Simbex Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00810082
• Other Study ID Numbers: TDI001
• First Posted: Dec 17, 2008
• Last Update Posted: May 23, 2018
• Last Verified: Apr 1, 2018

Study Results

Participant Flow

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

Arm/Group Title	Standard Physical Therapy Only	Physical Therapy Incuding ActiveStep
Arm/Group Description	Physical therapy for fall prevention according to the clinician's standard practice.	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.
Period Title: Overall Study
STARTED	34	31
COMPLETED	34	27
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	Standard Physical Therapy Only	Physical Therapy Incuding ActiveStep	Total
Arm/Group Description	Physical therapy for fall prevention according to the clinician's standard practice.	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 of all reporting groups
Overall Participants	34	31	65
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79.2 (7.65)	81.1 (7.53)	80.5 (7.3)
Sex: Female, Male (Count of Participants)
Female	23 67.6%	14 45.2%	37 56.9%
Male	11 32.4%	17 54.8%	28 43.1%
Region of Enrollment (participants) [Number]
United States	34 100%	31 100%	65 100%

Outcome Measures

1. Primary Outcome

Title	Participants With at Least One Fall
Description	Subjects who had at least one fall subsequent to treatment.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Physical Therapy Only	Physical Therapy Incuding ActiveStep
Arm/Group Description	Physical therapy for fall prevention according to the clinician's standard practice.	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.
Measure Participants	34	27
Number [participants]	11 32.4%	5 16.1%

Adverse Events

Arm/Group Title	Standard Physical Therapy Only		Physical Therapy Incuding ActiveStep
Arm/Group Description	Physical therapy for fall prevention according to the clinician's standard practice.		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.
All Cause Mortality
	Standard Physical Therapy Only		Physical Therapy Incuding ActiveStep
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Physical Therapy Only		Physical Therapy Incuding ActiveStep
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Standard Physical Therapy Only		Physical Therapy Incuding ActiveStep
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.