Trial Outcomes & Findings for Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability (NCT NCT03330262)
NCT ID: NCT03330262
Last Updated: 2021-03-10
Results Overview
This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).
COMPLETED
NA
13 participants
Week 0 (baseline)
2021-03-10
Participant Flow
Participant milestones
| Measure |
BALCAP Prosthesis, Then Control
Participants were asked to perform a series of appropriate exercises daily at home wearing the BALCAP prosthesis for a period of 6 weeks. After the 6 weeks of the BALCAP intervention, participants performed the control condition (the same exercises without the BALCAP worn). Tests were performed before and after each 6 week period.
The training exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.
BALCAP prosthesis: The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane.
|
Control, Then BALCAP Prosthesis
Participants were asked to perform a series of appropriate exercises daily at home for a period of 6 weeks without wearing the BALCAP prosthesis (control condition), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention condition). Tests were performed before and after each 6 week period.
The training exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, incorporating turns and movements other than straight forward walking, eyes open.
|
|---|---|---|
|
First Six Weeks
STARTED
|
7
|
6
|
|
First Six Weeks
COMPLETED
|
7
|
6
|
|
First Six Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Six Weeks
STARTED
|
7
|
6
|
|
Second Six Weeks
COMPLETED
|
5
|
5
|
|
Second Six Weeks
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
Baseline characteristics by cohort
| Measure |
BALCAP Prosthesis, Then Control
n=7 Participants
Participants performed exercises daily at home wearing the BALCAP prosthesis for 6 weeks. After 6 weeks, participants performed the control condition (the same exercises without the BALCAP). Tests were performed before and after each 6-week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
|
Control, Then BALCAP Prosthesis
n=6 Participants
Participants performed exercises daily at home for 6 weeks without wearing the BALCAP prosthesis (control), followed by another 6 weeks of the same exercises with the BALCAP prosthesis (intervention). Tests were performed before and after each 6 week period. Exercises included: (1) standing on a firm surface with feet apart, eyes open and closed; (2) standing on a firm surface with feet together, eyes open and closed; (3) standing on thick footing (e.g., multiple pairs of socks) with feet apart, eyes open and closed; (4) standing on thick footing with feet together, eyes open and closed; (5) standing in a modified Romberg position on a firm surface, eyes open and closed; (6) standing in a Romberg position on a firm surface, eyes open and closed; (7) walking on a firm surface eyes open; (8) walking with thick footing, eyes open; (9) walking with head turns and tilts, eyes open; and (10) walking around a room, with turns and movements other than straight forward walking, eyes open.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 (baseline)This outcome compared the Dynamic Gait Index score when the BALCAP prosthesis was worn vs. when it was not worn at baseline in order to evaluate if there is an assistive benefit to wearing the device. The Dynamic Gait Index (DGI) is a clinical tool to assess gait, balance, and fall risk using various walking tasks. The range of scores is 0 to 24. A higher score is better. All participants performed this test at baseline both wearing the BALCAP and not wearing the BALCAP. This test does not measure a change in DGI score over time but compares the results of the test while wearing the BALCAP vs. not wearing the BALCAP during the same evaluation period (baseline).
Outcome measures
| Measure |
All Participants
n=13 Participants
All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
|
Control
Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
|
|---|---|---|
|
Difference in Dynamic Gait Index (DGI)
|
0.77 units on a scale
Interval 0.16 to 1.38
|
—
|
SECONDARY outcome
Timeframe: Before and after 6 weeks of either the intervention or the control conditionChange in Computerized Dynamic Posturography (CDP): equilibrium score. Computerized Dynamic Posturography is used to assess balance disorders using a balance platform. CDP is used to determine postural stability; it measures a patient's ability to maintain balance under multiple conditions by testing visual, vestibular, and somatosensory balance components of the body. The equilibrium score is an overall indicator of balance. A score of 100 represents perfect stability and a score of 0 indicates a loss of balance. A higher value is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
Outcome measures
| Measure |
All Participants
n=10 Participants
All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
|
Control
n=10 Participants
Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
|
|---|---|---|
|
Change in Computerized Dynamic Posturography: Equilibrium Score
|
5.94 units on a scale
Interval 1.8 to 10.9
|
0.34 units on a scale
Interval -3.81 to 4.49
|
SECONDARY outcome
Timeframe: Week 0 (baseline)The gait speed of each participant was measured over a 25-foot difference when wearing the BALCAP vs when not wearing the BALCAP. This test was performed on all participants at baseline prior to the home studies. A higher value represents faster gait speed. This test is intended to measure the assistive benefit of the BALCAP prosthesis.
Outcome measures
| Measure |
All Participants
n=13 Participants
All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
|
Control
Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
|
|---|---|---|
|
Difference in Gait Speed
|
0.03 meters/second
Interval -0.05 to 0.11
|
—
|
SECONDARY outcome
Timeframe: Before and after 6 weeks of either the intervention or the control conditionChange in Activities-specific Balance Confidence (ABC) Scale. The Activities-specific Balance Confidence Scale is a self-report questionnaire that measures an individual's confidence in performing activities without losing balance. The score range is from 0 to 100. A higher value is better.
Outcome measures
| Measure |
All Participants
n=10 Participants
All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
|
Control
n=10 Participants
Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
|
|---|---|---|
|
Change in Activities-specific Balance Confidence (ABC) Scale
|
6.04 units on a scale
Interval -5.45 to 17.53
|
1.39 units on a scale
Interval -10.1 to 12.88
|
SECONDARY outcome
Timeframe: Before and after 6 weeks of either the intervention or the control conditionChange in Dizziness Handicap Inventory score. The Dizziness Handicap Inventory (DHI) is a common self-report quality of life measure for vestibular disorders. The score range is from 0 to 100 and a lower score is better. This test is intended to ascertain if there is a rehabilitative benefit of using the BALCAP instrument.
Outcome measures
| Measure |
All Participants
n=10 Participants
All participants performed the dynamic gait index at baseline both with and without the BALCAP prosthesis.
|
Control
n=10 Participants
Participants who did not wear the BALCAP prosthesis when performing the exercises in either the first six weeks or the second six weeks of the protocol.
|
|---|---|---|
|
Change in Dizziness Handicap Inventory Score
|
-7.33 units on a scale
Interval -18.66 to 3.99
|
2.00 units on a scale
Interval -9.32 to 13.32
|
Adverse Events
BALCAP Prosthesis
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place