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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538029
• Other study ID #: 15-1000
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 16, 2017

Study information

• Verified date: February 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Dual Task Group
Performing motor-motor or motor-cognitive tasks at the same time.
• Single Task Group
Performing motor or cognitive tasks alone.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Davis Phinney Foundation

Country where clinical trial is conducted

United States, 

Outcome

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