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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Functional Near-Infrared Spectroscopy (fNIRS)

• Registration Number: NCT05073874
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Study Start: 2021-12-08
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Near-Infrared Spectroscopy (fNIRS)	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.

Primary Outcome Measures

Name	Time	Method
Effects of oxyhemoglobin variations on hemodynamic response in prefrontal cortex	Baseline	Oxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system, on a 20 meters distance.
Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex	Baseline	Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHR Orléans; 🇫🇷 Orléans, France