Trial Outcomes & Findings for Bracing for Walking in Parkinson's Disease (NCT NCT03192046)
NCT ID: NCT03192046
Last Updated: 2022-03-23
Results Overview
The 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).
COMPLETED
NA
10 participants
Baseline and 6 months
2022-03-23
Participant Flow
Participant milestones
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Bracing for Walking in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
n=5 Participants
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
n=4 Participants
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsThe 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).
Outcome measures
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
n=4 Participants
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
n=3 Participants
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
|---|---|---|
|
Change in Gait Capacity as Assessed b 6-Minute Walk Test
|
235.7 Feet
Standard Deviation 155.9
|
150.0 Feet
Standard Deviation 270.0
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsParticipants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Outcome measures
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
n=4 Participants
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
n=3 Participants
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
|---|---|---|
|
Change in Step Length
|
4.0 cm
Standard Deviation 1.8
|
0.7 cm
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsEach subject will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial gait parameters.
Outcome measures
| Measure |
Carbon Fiber Ankle Foot Orthosis (AFO)
n=4 Participants
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
Control Group, Walking Program Only
n=3 Participants
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Carbon Fiber Ankle Foot Orthosis (AFO): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
|
|---|---|---|
|
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
|
21.7 Cm/sec
Standard Deviation 18.8
|
6.26 Cm/sec
Standard Deviation 10.7
|
Adverse Events
Carbon Fiber Ankle Foot Orthosis (AFO)
Control Group, Walking Program Only
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