Parkinson's DiseaseNCT02538029

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

A study testing Dual Task Group and Single Task Group in people with Parkinson's Disease, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Parkinson's Disease
What is being tested?: Dual Task Group and Single Task Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Aug 2015to 16 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis of idiopathic PD
Able to provide informed consent
Ability to ambulate ≥ 300ft with or without an assistive device
Hoehn and Yahr stage 2-4

Who cannot join

Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
Inability to follow 2 step commands
Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease

The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.

Conditions: Parkinson's Disease
Being tested: Dual Task Group, Single Task Group
Keywords: Dual tasking
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual Task GroupBehavioural
Performing motor-motor or motor-cognitive tasks at the same time.
Single Task GroupBehavioural
Performing motor or cognitive tasks alone.

Study groups in NCT02538029
Study group	Role	What they receive
Dual Task Group	Experimental	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. Receives: Behavioral: Dual Task Group
Single Task Group	Active comparator	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. Receives: Behavioral: Single Task Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Step Length During Gait
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.
Measured: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Walking Speed During Gait
Average self-selected walking speed without dual tasking.
Measured: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

Secondary outcomes (5)

2 Minute Walk Test
A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Measured: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Quality of Life in Neurological Disorders Questionnaire
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.
Measured: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Activities-specific Balance Confidence Scale
Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Measured: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Trail Making Test
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.
Measured: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Reaction Time
Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Measured: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201516 Aug 2017

First posted2 Sep 2015 (estimated)
Study startAug 2015
Primary completion16 Aug 2017
Study completion16 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02538029
Sponsor's protocol ID: 15-1000
Status last verified: Feb 2019
First submitted: 17 Aug 2015
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Penko AL, Barkley JE, Rosenfeldt AB, Alberts JL. Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease. J Phys Act Health. 2019 Dec 1;16(12):1085-1091. doi: 10.1123/jpah.2018-0595. Epub 2019 Oct 24.
PubMed 31648204
Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. Improvements in temporal and postural aspects of gait vary following single- and multi-modal training in individuals with Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:280-285. doi: 10.1016/j.parkreldis.2019.05.021. Epub 2019 May 14.
PubMed 31103489
Rosenfeldt AB, Penko AL, Bazyk AS, Streicher MC, Dey T, Alberts JL. The Two Minute Walk Test Overground and on a Self-Paced Treadmill Detects Dual Task Deficits in Individuals With Parkinson's Disease. J Aging Phys Act. 2019 Dec 1;27(4):843-847. doi: 10.1123/japa.2018-0264.
PubMed 31034314

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
ClinicalTrials.gov ID: NCT02538029
Acronym / sponsor ID: 15-1000
Conditions: Parkinson's Disease
Keywords: Dual tasking
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Davis Phinney Foundation
Study start: Aug 2015
Primary completion: 16 Aug 2017 (actual)
Study completion: 16 Aug 2017 (actual)
First posted: 2 Sep 2015 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dual Task Group	Experimental	Behavioral: Dual Task GroupThis 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.
Single Task Group	Active comparator	Behavioral: Single Task GroupThis 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of idiopathic PD
Able to provide informed consent
Ability to ambulate ≥ 300ft with or without an assistive device
Hoehn and Yahr stage 2-4

Key exclusion criteria (5 listed)

Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
Inability to follow 2 step commands
Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual Task GroupPerforming motor-motor or motor-cognitive tasks at the same time.	Behavioural	Dual Task Group
Single Task GroupPerforming motor or cognitive tasks alone.	Behavioural	Single Task Group

Primary outcome

Step Length During Gait
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
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.
Walking Speed During Gait
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Average self-selected walking speed without dual tasking.

5 secondary outcomes

2 Minute Walk Test
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Quality of Life in Neurological Disorders Questionnaire
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Activities-specific Balance Confidence Scale
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Trail Making Test
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Reaction Time
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1	24	23
Phase 2: Dual Task	10	10
Phase 2: Single Task	11	10

Primary outcome: Step Length During Gait

Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks. Mean (Standard Deviation). Unit: meters

Measure	Phase 1 n = 23	Phase 2: Dual Task n = 10	Phase 2: Single Task n = 10
Baseline	0.57 (0.14)	0.63 (0.15)	0.54 (0.15)
End of Treatment	–	0.72 (0.12)	0.66 (0.17)
End of Treatment+4 weeks	–	0.71 (0.12)	0.67 (0.16)

Population analysed: 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.

Primary outcome: Walking Speed During Gait

Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks. Mean (Standard Deviation). Unit: meters/second

Measure	Phase 1 n = 23	Phase 2: Dual Task n = 10	Phase 2: Single Task n = 10
Baseline	1.24 (0.21)	1.19 (0.34)	1.00 (0.27)
End of Treatment	–	1.41 (0.30)	1.25 (0.35)
End of Treatment+4 weeks	–	1.39 (0.30)	1.29 (0.37)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Phase 2: Dual Task	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Phase 2: Single Task	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31648204Penko AL, Barkley JE, Rosenfeldt AB, Alberts JL. Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease. J Phys Act Health. 2019 Dec 1;16(12):1085-1091. doi: 10.1123/jpah.2018-0595. Epub 2019 Oct 24.
Derived from this study: PubMed 31103489Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. Improvements in temporal and postural aspects of gait vary following single- and multi-modal training in individuals with Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:280-285. doi: 10.1016/j.parkreldis.2019.05.021. Epub 2019 May 14.
Derived from this study: PubMed 31034314Rosenfeldt AB, Penko AL, Bazyk AS, Streicher MC, Dey T, Alberts JL. The Two Minute Walk Test Overground and on a Self-Paced Treadmill Detects Dual Task Deficits in Individuals With Parkinson's Disease. J Aging Phys Act. 2019 Dec 1;27(4):843-847. doi: 10.1123/japa.2018-0264.
Individual participant dataSharing planned: No

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jay Alberts, PhD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dual Task Group and Single Task Group in people with Parkinson's Disease, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step Length During Gait (time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02538029, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.