Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD) (AttPark)

August 1, 2024 updated by: Centre Hospitalier Régional d'Orléans

Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease

Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus: internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty older adults and thirty PD will participate in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The subjects will be guided to walk at a normal pace while maintaining the required attentional focus. Subjects will walk on 20 m four times in each of the four different focus conditions :

  1. no instructions about the attentional focus
  2. internal focus on their feet movements,
  3. external focus on two lines drawn on the floor,
  4. divided attention (walking while performing an arithmetic task).

A fNIRS system will be used for the prefrontal cortex activation evaluation and FeetMe soles for gait analyses.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • CHR Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • For 2 groups :

    • Man or woman 60-85 years old
    • Informed consent obtained
  • Group Parkinson : clinical diagnosis of idiopathic Parkinson's Disease, according to the UK Brain Bank criteria.

Exclusion Criteria:

  • For 2 groups :

    • Assisted walker
    • Neurological (other than those resulting from Parkinson's disease), cardiologic, rheumatologic disorders
    • Disorders affecting gait.
    • Montreal Cognitive Assessment (MOCA) < 24.
    • Concomitant medication likely to interfere with the results.

  • Group Parkinson:

    • freezing
    • Hoehn et Yahr > III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Functional Near-Infrared Spectroscopy (fNIRS)

Subjects will be guided to walk at a normal pace while maintaining the required attentional focus:

  1. no instructions about the attentional focus
  2. internal focus on their feet movements,
  3. external focus on two lines drawn on the floor,
  4. divided attention (walking while performing an arithmetic task).

A fNIRS system will be used for the prefrontal cortex activation evaluation and connected soles for gait analyses.
Other: Functional Near-Infrared Spectroscopy (fNIRS)
The hemodynamic response in prefrontal cortex will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of oxyhemoglobin variations on hemodynamic response in prefrontal cortex
Time Frame: Baseline
Oxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system, on a 20 meters distance.
Baseline
Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex
Time Frame: Baseline
Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of speed on gait.
Time Frame: baseline
Gait parameters will be measured with connected soles FeetMe ® : speed
baseline
Effects of cadence on gait.
Time Frame: baseline
Gait parameters will be measured with connected soles FeetMe ® : cadence
baseline
Effects of stride length on gait.
Time Frame: baseline
Gait parameters will be measured with connected soles FeetMe ® : stride length
baseline
Effects of double support time on gait.
Time Frame: baseline
Gait parameters will be measured with connected soles FeetMe ® : double support time.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Canan OZSANCAK, Dr, CHR d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2021-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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