Trial Outcomes & Findings for Impact of Walking Practice on Persons With PD (NCT NCT02113189)
NCT ID: NCT02113189
Last Updated: 2019-03-22
Results Overview
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
6MWT will be done at initial testing and 12 months
Results posted on
2019-03-22
Participant Flow
Participant milestones
| Measure |
Walking Program With Ankle Brace
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
|
Individualized Walking Program
This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking
|
Walking Program With Custom Braces
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
Walking Program With Ankle Brace
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
|
Individualized Walking Program
This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking
|
Walking Program With Custom Braces
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
|
|---|---|---|---|
|
Overall Study
Lost to follow up
|
2
|
1
|
3
|
Baseline Characteristics
Impact of Walking Practice on Persons With PD
Baseline characteristics by cohort
| Measure |
Walking Program With Ankle Brace
n=4 Participants
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
|
Individualized Walking Program
n=4 Participants
This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking
|
Walking Program With Custom Braces
n=5 Participants
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
|
Total
n=13 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Continuous
|
62 years
n=99 Participants
|
71 years
n=107 Participants
|
70 years
n=206 Participants
|
68 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6MWT will be done at initial testing and 12 monthsEach participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Outcome measures
| Measure |
Walking Program With Ankle Brace
n=2 Participants
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
|
Individualized Walking Program
n=3 Participants
This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking
|
Walking Program With Custom Braces
n=2 Participants
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
|
|---|---|---|---|
|
Change in Distance Walked on 6-Minute Walk Test (6MWT)
|
261 feet
Interval 196.0 to 326.0
|
56 feet
Interval -163.0 to 187.0
|
31 feet
Interval -130.0 to 192.0
|
SECONDARY outcome
Timeframe: Testing will be done at initial testing and 12 monthsParticipants 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 parameters.
Outcome measures
| Measure |
Walking Program With Ankle Brace
n=2 Participants
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Walking program with ankle brace: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
|
Individualized Walking Program
n=3 Participants
This group will receive a customized walking program.
Individualized walking program: Walking program will include instructions on walking activities at home such as time of walking
|
Walking Program With Custom Braces
n=2 Participants
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Walking program with custom braces.: Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
|
|---|---|---|---|
|
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
|
22 cm/sec
Interval 15.0 to 30.0
|
5 cm/sec
Interval -11.0 to 9.0
|
3 cm/sec
Interval -7.0 to 8.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 monthsPopulation: This was a self-reported data set. Patients had logs to record daily steps from pedometers for each week. Data was not reported accurately from all participants, thus data set is incomplete. Analysis cannot be completed.
Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded.
Outcome measures
Outcome data not reported
Adverse Events
Walking Program With Ankle Brace
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individualized Walking Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Walking Program With Custom Braces
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
Karen McCain, PT, DPT, NCS
University of Texas Southwestern Medical Center
Phone: 2146481559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place