Trial Outcomes & Findings for The Effects of Dual Task Training in Individuals With Parkinson's Disease (NCT NCT02538029)
NCT ID: NCT02538029
Last Updated: 2019-05-03
Results Overview
The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Results posted on
2019-05-03
Participant Flow
Participant milestones
| Measure |
Phase 1
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
10
|
11
|
|
Overall Study
COMPLETED
|
23
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase 1
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Overall Study
unable to complete cognitive assessments
|
1
|
0
|
1
|
Baseline Characteristics
The Effects of Dual Task Training in Individuals With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Phase 1
n=23 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
n=10 Participants
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.61 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
58.90 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
64.60 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
62.74 years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 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
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 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
|
23 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Step Length
|
0.57 meters
STANDARD_DEVIATION 0.14 • n=5 Participants
|
0.63 meters
STANDARD_DEVIATION 0.15 • n=7 Participants
|
0.54 meters
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.58 meters
STANDARD_DEVIATION 0.14 • n=4 Participants
|
|
Walking Speed
|
1.24 meters/second
STANDARD_DEVIATION 0.14 • n=5 Participants
|
1.19 meters/second
STANDARD_DEVIATION 0.34 • n=7 Participants
|
1.00 meters/second
STANDARD_DEVIATION 0.27 • n=5 Participants
|
1.18 meters/second
STANDARD_DEVIATION 0.14 • n=4 Participants
|
PRIMARY outcome
Timeframe: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.
The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
n=10 Participants
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Step Length During Gait
Baseline
|
0.57 meters
Standard Deviation 0.14
|
0.63 meters
Standard Deviation 0.15
|
0.54 meters
Standard Deviation 0.15
|
|
Step Length During Gait
End of Treatment
|
—
|
0.72 meters
Standard Deviation 0.12
|
0.66 meters
Standard Deviation 0.17
|
|
Step Length During Gait
End of Treatment+4 weeks
|
—
|
0.71 meters
Standard Deviation 0.12
|
0.67 meters
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.
Average self-selected walking speed without dual tasking.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
n=10 Participants
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Walking Speed During Gait
End of Treatment
|
—
|
1.41 meters/second
Standard Deviation 0.30
|
1.25 meters/second
Standard Deviation 0.35
|
|
Walking Speed During Gait
End of Treatment+4 weeks
|
—
|
1.39 meters/second
Standard Deviation 0.30
|
1.29 meters/second
Standard Deviation 0.37
|
|
Walking Speed During Gait
Baseline
|
1.24 meters/second
Standard Deviation 0.21
|
1.19 meters/second
Standard Deviation 0.34
|
1.00 meters/second
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.
A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
n=10 Participants
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
2 Minute Walk Test
Baseline
|
158.10 meters
Standard Deviation 25.98
|
135.28 meters
Standard Deviation 21.33
|
134.94 meters
Standard Deviation 35.19
|
|
2 Minute Walk Test
End of Treatment
|
—
|
147.53 meters
Standard Deviation 22.30
|
140.15 meters
Standard Deviation 33.18
|
|
2 Minute Walk Test
End of Treatment +4 weeks
|
—
|
143.77 meters
Standard Deviation 20.35
|
139.27 meters
Standard Deviation 31.79
|
SECONDARY outcome
Timeframe: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.
Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Phase 1
n=10 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Quality of Life in Neurological Disorders Questionnaire
Baseline
|
43.84 T-score
Standard Deviation 5.85
|
44.84 T-score
Standard Deviation 7.69
|
—
|
|
Quality of Life in Neurological Disorders Questionnaire
End of Treatment
|
45.76 T-score
Standard Deviation 5.95
|
44.17 T-score
Standard Deviation 8.10
|
—
|
|
Quality of Life in Neurological Disorders Questionnaire
End of Treatment +4 weeks
|
46.14 T-score
Standard Deviation 5.96
|
45.85 T-score
Standard Deviation 7.99
|
—
|
SECONDARY outcome
Timeframe: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses.
Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Outcome measures
| Measure |
Phase 1
n=10 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Activities-specific Balance Confidence Scale
Baseline
|
78.44 units on a scale
Standard Deviation 19.34
|
75.44 units on a scale
Standard Deviation 22.94
|
—
|
|
Activities-specific Balance Confidence Scale
End of Treatment
|
83.69 units on a scale
Standard Deviation 16.92
|
76.44 units on a scale
Standard Deviation 18.64
|
—
|
|
Activities-specific Balance Confidence Scale
End of Treatment +4 weeks
|
83.81 units on a scale
Standard Deviation 11.19
|
79.38 units on a scale
Standard Deviation 15.90
|
—
|
SECONDARY outcome
Timeframe: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.
Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task.
Outcome measures
| Measure |
Phase 1
n=10 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Trail Making Test
Baseline
|
31.15 seconds
Standard Deviation 13.99
|
40.72 seconds
Standard Deviation 28.22
|
—
|
|
Trail Making Test
End of Treatment
|
28.82 seconds
Standard Deviation 8.07
|
38.44 seconds
Standard Deviation 20.44
|
—
|
|
Trail Making Test
End of Treatment +4 weeks
|
30.18 seconds
Standard Deviation 11.68
|
41.57 seconds
Standard Deviation 25.37
|
—
|
SECONDARY outcome
Timeframe: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeksPopulation: One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.
Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Outcome measures
| Measure |
Phase 1
n=10 Participants
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 Participants
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
Reaction Time
Baseline
|
533.50 milliseconds
Standard Deviation 83.85
|
513.44 milliseconds
Standard Deviation 129.78
|
—
|
|
Reaction Time
End of Treatment
|
510.24 milliseconds
Standard Deviation 70.94
|
535.76 milliseconds
Standard Deviation 119.62
|
—
|
|
Reaction Time
End of Treatment +4 weeks
|
532.49 milliseconds
Standard Deviation 88.21
|
558.55 milliseconds
Standard Deviation 197.19
|
—
|
Adverse Events
Phase 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2: Dual Task
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2: Single Task
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 |
Phase 1
n=24 participants at risk
Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit.
|
Phase 2: Dual Task
n=10 participants at risk
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
|
Phase 2: Single Task
n=11 participants at risk
This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks.
|
|---|---|---|---|
|
General disorders
Fall without injury
|
4.2%
1/24 • Number of events 1 • Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks)
|
10.0%
1/10 • Number of events 1 • Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks)
|
0.00%
0/11 • Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place