Trial Outcomes & Findings for Combined Cognitive and Gait Training (NCT NCT02362282)
NCT ID: NCT02362282
Last Updated: 2019-02-11
Results Overview
Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
pre-training (0 weeks), post training (about 12 weeks)
Results posted on
2019-02-11
Participant Flow
Participants were screened out if presenting with unstable medical conditions that could affect safety.
Participant milestones
| Measure |
Gait and Cognitive Training
Gait rehabilitation combined with cognitive rehabilitation
|
Gait and Arm Training
Gait rehabilitation combined with arm (reach/grasp) rehabilitation
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Gait and Cognitive Training
Gait rehabilitation combined with cognitive rehabilitation
|
Gait and Arm Training
Gait rehabilitation combined with arm (reach/grasp) rehabilitation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Combined Cognitive and Gait Training
Baseline characteristics by cohort
| Measure |
Gait and Cognitive Training
n=5 Participants
Gait rehabilitation combined with cognitive rehabilitation
|
Gait and Arm Training
n=7 Participants
Gait rehabilitation combined with arm (reach/grasp) rehabilitation
|
Total
n=12 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-training (0 weeks), post training (about 12 weeks)Population: Adults with chronic post-stroke hemiparesis and gait deficits
Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait).
Outcome measures
| Measure |
Gait and Cognitive Training
n=4 Participants
Gait rehabilitation combined with cognitive rehabilitation
|
Gait and Arm Training
n=7 Participants
Gait rehabilitation combined with arm (reach/grasp) rehabilitation
|
|---|---|---|
|
Change in the Gait Assessment and Intervention (G.A.I.T.) Score
pre treatment mean
|
28.8 units on a scale
Standard Deviation 6.9
|
29.5 units on a scale
Standard Deviation 3.8
|
|
Change in the Gait Assessment and Intervention (G.A.I.T.) Score
post treatment mean
|
29.9 units on a scale
Standard Deviation 5.9
|
28.7 units on a scale
Standard Deviation 7.7
|
Adverse Events
Gait and Cognitive Training
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gait and Arm Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gait and Cognitive Training
n=4 participants at risk
Gait rehabilitation combined with cognitive rehabilitation
|
Gait and Arm Training
n=7 participants at risk
Gait rehabilitation combined with arm (reach/grasp) rehabilitation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
Additional Information
Janis J Daly, Ph.D., Director Brain Rehabilitation Research Center
North Florida/South Georgia Gainesville VA Medical Center
Phone: 352-548-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place