Trial Outcomes & Findings for Incline Training to Personalize Motor Control Interventions After Stroke (NCT NCT03561246)
NCT ID: NCT03561246
Last Updated: 2024-05-22
Results Overview
Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
Personalized Training Effect on SSWS and Pp - Incline
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Decline
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL treadmill training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incline Training to Personalize Motor Control Interventions After Stroke
Baseline characteristics by cohort
| Measure |
Personalized Training Effect on SSWS and Pp - Incline
n=19 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Decline
n=19 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)
n=17 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Total
n=55 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Continuous
|
61.32 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
60.79 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
61 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
60.96 years
STANDARD_DEVIATION 9.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
00 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
Outcome measures
| Measure |
Personalized Training Effect on SSWS and Pp - Incline
n=19 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Decline
n=18 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)
n=17 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
|---|---|---|---|
|
Change in Gait Speed
|
0.15 meters/second
Standard Deviation 0.004
|
0.075 meters/second
Standard Deviation 0.053
|
0.127 meters/second
Standard Deviation 0.062
|
SECONDARY outcome
Timeframe: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.
Outcome measures
| Measure |
Personalized Training Effect on SSWS and Pp - Incline
n=19 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Decline
n=18 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)
n=17 Participants
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp).
Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
|
|---|---|---|---|
|
Change in Paretic Propulsion Symmetry
|
-0.023 Percentage of Propulsion
Standard Deviation 0.042
|
-0.034 Percentage of Propulsion
Standard Deviation 0.020
|
0.043 Percentage of Propulsion
Standard Deviation 0.013
|
Adverse Events
Personalized Training Effect on SSWS and Pp - Incline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Training Effect on SSWS and Pp - Decline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Training Effect on SSWS and Pp - Level Treadmill (Control)
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
Mark G. Bowden - PI
Brooks Rehabilitation Clinical Research Center
Phone: 904-345-6626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place