NCT02538029

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 3, 2019

Completed
Last Updated

May 3, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

August 17, 2015

Results QC Date

July 16, 2018

Last Update Submit

February 4, 2019

Conditions

Parkinson's Disease

Keywords

Dual tasking

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

Secondary Outcomes (5)

  • 2 Minute Walk Test

    Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

  • Quality of Life in Neurological Disorders Questionnaire

    Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

  • Activities-specific Balance Confidence Scale

    Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

  • Trail Making Test

    Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

  • Reaction Time

    Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks

Study Arms (2)

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.

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.

Behavioral: Single Task Group

Interventions

Dual Task GroupBEHAVIORAL

Performing motor-motor or motor-cognitive tasks at the same time.

Dual Task Group
Single Task GroupBEHAVIORAL

Performing motor or cognitive tasks alone.

Single Task Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • 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.

    PMID: 31648204DERIVED

  • 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.

    PMID: 31103489DERIVED

  • 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.

    PMID: 31034314DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Dr. Jay Alberts
Organization
Cleveland Clinic
albertj@ccf.org
216 445-3222

Study Officials

  • Jay Alberts, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff

Study Record Dates

First Submitted

August 17, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

May 3, 2019

Results First Posted

May 3, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)