fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects

NCT06116006 | Completed

• 1 other identifier: 2022-A02827-36
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Following a stroke, as part of neurorehabilitation, the intensity of effort is important to promote neural changes and stimulate motor recovery. There are few studies concerning the cortical activity involved at different levels of intensity during upper limb motor training. Objective: To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.

Conditions

Stroke; Healthy

Keywords

stroke; upper limb; robot-based therapy; physical modalities; effort; fnirs; cortical activation

Outcome Measures

Primary Outcomes (2)

• Change of oxyhemoglobin concentration during upper limb tasks

  Day 0

• Change of desoxyhemoglobin concentration during upper limb tasks

  Day 0

Study Arms (1)

Subjects with 3 experimental conditions

OTHER

3 types of upper limb pointing movements: * movements with robot assistance * movements without robot assistance * movements with robot resistance

Other: Upper limb pointing movements in 3 experimental conditions

Interventions

Upper limb pointing movements in 3 experimental conditions OTHER

Recording of cerebral hemodynamic with fNIRS during upper limb pointing movements with a robotic device in three conditions: movements with robot assistance, movements without robot assistance and movements with robot resistance. Each subject are recorded during 6 trials for each condition (18 trials). The order is counterbalanced among the subjects.

Subjects with 3 experimental conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For stroke subjects
• Age ≥18 years;
• Stroke-induced hemiparesis, chronic phase (\>6 months post-stroke);
• Moderate upper limb paresis defined by an upper limb FMA score 20 pts \< FMA score \< 47 pts ;
• Right-handed patient;
• Patient having agreed to sign an informed consent form;
• Patient affiliated to the French social security system.
• For healthy subjects
• Age-matched participant, for each stroke subject included will be associated a control subject of the same age (to the nearest 5 years);
• Right-handed participant;
• Participant having agreed to sign an informed consent form;
• Participant affiliated to the French social security system.
• For stroke subjects
• Cognitive impairment making participation in the study impossible;
• Phasic disorders preventing comprehension of instructions and effective communication.

Sponsors & Collaborators

• Clinique Les Trois Soleils: lead
• Centre Hospitalier Régional d'Orléans: collaborator

Study Sites (1)

La Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Location

Related Publications (2)

• Shi P, Li A, Yu H. Response of the Cerebral Cortex to Resistance and Non-resistance Exercise Under Different Trajectories: A Functional Near-Infrared Spectroscopy Study. Front Neurosci. 2021 Oct 13;15:685920. doi: 10.3389/fnins.2021.685920. eCollection 2021.

  PMID: 34720845 BACKGROUND

• Zheng J, Shi P, Fan M, Liang S, Li S, Yu H. Effects of passive and active training modes of upper-limb rehabilitation robot on cortical activation: a functional near-infrared spectroscopy study. Neuroreport. 2021 Apr 7;32(6):479-488. doi: 10.1097/WNR.0000000000001615.

  PMID: 33788815 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: January 15, 2024
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)