Trial Outcomes & Findings for Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability (NCT NCT00889824)

Results Overview

The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-02-15

Participant Flow

Participants were recruited from 7/10/2009 through 6/30/2012 from Dr. Goebel's clinical practice.

There was no run-in or washout. All participants received the intervention.

Participant milestones

Participant milestones
Measure	Balcap Group Balcap group Balcap group; balance prosthesis : vibrotactile stimulation Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a "buzz" either in front, back, or either side of their head when they swayed a certain distance from their "center". They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later. Each patient wore the balcap device a total of six weeks and then returned the device.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balcap Group n=5 Participants Each participant received Balcap Tactile prosthesis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.

The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.

Outcome measures

Outcome measures
Measure	Balcap Group n=5 Participants Vibrotactile stimulation exercises with the device over a span of 6 weeks
Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.	4.3 units on a scale Standard Deviation 0.040

Adverse Events

Balcap Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Goebel, MD

WashingtonU

Phone: (314) 362-7344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place