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The Effects of Dual Task Training in Individuals With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538029
Recruitment Status : Completed
First Posted : September 2, 2015
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Davis Phinney Foundation
Information provided by (Responsible Party):
Jay Alberts, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Behavioral: Dual Task Group
Behavioral: Single Task Group
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 24 10 11
Completed 23 10 10
Not Completed 1 0 1
Reason Not Completed
unable to complete cognitive assessments             1             0             1
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 23 10 10 43
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 10 participants 10 participants 43 participants
63.61  (7.00) 58.90  (8.50) 64.60  (8.46) 62.74  (7.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 10 participants 10 participants 43 participants
Female
12
  52.2%
5
  50.0%
1
  10.0%
18
  41.9%
Male
11
  47.8%
5
  50.0%
9
  90.0%
25
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 10 participants 10 participants 43 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  10.0%
1
   2.3%
Not Hispanic or Latino
23
 100.0%
10
 100.0%
9
  90.0%
42
  97.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 10 participants 10 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  10.0%
1
   2.3%
White
23
 100.0%
10
 100.0%
9
  90.0%
42
  97.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 10 participants 10 participants 43 participants
23 10 10 44
Step Length   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 23 participants 10 participants 10 participants 43 participants
0.57  (0.14) 0.63  (0.15) 0.54  (0.15) 0.58  (0.14)
[1]
Measure Description: The average distance from heel strike of the less affected leg to heel strike of the more affected leg.
Walking Speed   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters/second
Number Analyzed 23 participants 10 participants 10 participants 43 participants
1.24  (0.14) 1.19  (0.34) 1.00  (0.27) 1.18  (0.14)
[1]
Measure Description: Average self-selected walking speed without dual tasking.
1.Primary Outcome
Title Step Length During Gait
Hide Description 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.
Time Frame Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 23 10 10
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 23 participants 10 participants 10 participants
0.57  (0.14) 0.63  (0.15) 0.54  (0.15)
End of Treatment Number Analyzed 0 participants 10 participants 10 participants
0.72  (0.12) 0.66  (0.17)
End of Treatment+4 weeks Number Analyzed 0 participants 10 participants 10 participants
0.71  (0.12) 0.67  (0.16)
2.Primary Outcome
Title Walking Speed During Gait
Hide Description Average self-selected walking speed without dual tasking.
Time Frame Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 23 10 10
Mean (Standard Deviation)
Unit of Measure: meters/second
Baseline Number Analyzed 23 participants 10 participants 10 participants
1.24  (0.21) 1.19  (0.34) 1.00  (0.27)
End of Treatment Number Analyzed 0 participants 10 participants 10 participants
1.41  (0.30) 1.25  (0.35)
End of Treatment+4 weeks Number Analyzed 0 participants 10 participants 10 participants
1.39  (0.30) 1.29  (0.37)
3.Secondary Outcome
Title 2 Minute Walk Test
Hide Description A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Time Frame Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 23 10 10
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 23 participants 10 participants 10 participants
158.10  (25.98) 135.28  (21.33) 134.94  (35.19)
End of Treatment Number Analyzed 0 participants 10 participants 10 participants
147.53  (22.30) 140.15  (33.18)
End of Treatment +4 weeks Number Analyzed 0 participants 10 participants 10 participants
143.77  (20.35) 139.27  (31.79)
4.Secondary Outcome
Title Quality of Life in Neurological Disorders Questionnaire
Hide Description 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.
Time Frame Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: T-score
Baseline Number Analyzed 10 participants 10 participants
43.84  (5.85) 44.84  (7.69)
End of Treatment Number Analyzed 10 participants 10 participants
45.76  (5.95) 44.17  (8.10)
End of Treatment +4 weeks Number Analyzed 10 participants 9 participants
46.14  (5.96) 45.85  (7.99)
5.Secondary Outcome
Title Activities-specific Balance Confidence Scale
Hide Description Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Time Frame Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses.
Arm/Group Title Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 78.44  (19.34) 75.44  (22.94)
End of Treatment 83.69  (16.92) 76.44  (18.64)
End of Treatment +4 weeks 83.81  (11.19) 79.38  (15.90)
6.Secondary Outcome
Title Trail Making Test
Hide Description 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.
Time Frame Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline Number Analyzed 10 participants 10 participants
31.15  (13.99) 40.72  (28.22)
End of Treatment Number Analyzed 10 participants 10 participants
28.82  (8.07) 38.44  (20.44)
End of Treatment +4 weeks Number Analyzed 10 participants 9 participants
30.18  (11.68) 41.57  (25.37)
7.Secondary Outcome
Title Reaction Time
Hide Description Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Time Frame Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline Number Analyzed 10 participants 10 participants
533.50  (83.85) 513.44  (129.78)
End of Treatment Number Analyzed 10 participants 10 participants
510.24  (70.94) 535.76  (119.62)
End of Treatment +4 weeks Number Analyzed 10 participants 9 participants
532.49  (88.21) 558.55  (197.19)
Time Frame Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 Phase 2: Dual Task Phase 2: Single Task
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Phase 1 Phase 2: Dual Task Phase 2: Single Task
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/10 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Phase 1 Phase 2: Dual Task Phase 2: Single Task
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/10 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1 Phase 2: Dual Task Phase 2: Single Task
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      1/10 (10.00%)      0/11 (0.00%)    
General disorders       
Fall without injury   1/24 (4.17%)  1 1/10 (10.00%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jay Alberts
Organization: Cleveland Clinic
Phone: 216 445-3222
EMail: albertj@ccf.org
Layout table for additonal information
Responsible Party: Jay Alberts, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02538029    
Other Study ID Numbers: 15-1000
First Submitted: August 17, 2015
First Posted: September 2, 2015
Results First Submitted: July 16, 2018
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019