Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia

NCT03190863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-09-29

No results posted yet for this study

Summary

Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.

The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.

Conditions

  • Individuals With C6-C7 Tetraplegia (AIS A or B)

Interventions

BEHAVIORAL

Motor imagery combined with neurofeedback (MINF)

7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement). Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen.

BEHAVIORAL

Motor imagery (MI)

7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.

BEHAVIORAL

Control (C)

7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen. Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Sébastien MATEO, PhD · Hospices Civils de Lyon, Hôpital Henry Gabrielle, Plate-forme Mouvement et Handicap, F-69000 Lyon, France.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2025-05-29
Completion
2025-05-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190863 on ClinicalTrials.gov