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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2025-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Motor imagery combined with neurofeedback (MINF)

Group Type EXPERIMENTAL

Motor imagery combined with neurofeedback (MINF)

Intervention Type BEHAVIORAL

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.

Motor imagery (MI)

Group Type ACTIVE_COMPARATOR

Motor imagery (MI)

Intervention Type BEHAVIORAL

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.

Control (C)

Group Type SHAM_COMPARATOR

Control (C)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis restricting grasping capabilities to the tenodesis.
* Consent to participate to the study after receiving clear, loyal and appropriate information.
* Aged between 18 and 55 years.
* Time since spinal cord injury above 6 months
* Stabilized condition in particular sensori-motor deficit.
* Sitting position for more than 1 hour
* Able to imagine movement
* Health care beneficiary

Exclusion Criteria

* Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood pressure instability) limiting sitting position to less than 1 hour.
* Upper limb pain for either mechanic or neuropathic reasons preventing all grasping movement and/or the ability to imagine those movements.
* Restricted wrist and finger range of motion preventing the tenodesis grasp.
* Patient after surgical tendon transfer that improved grasping capabilities (e.g. active finger flexion).
* Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
* Specific contraindication to Magnetoencephalography with the presence of metallic fragments inside the body such as pace-maker, neurostimulator, cochlear implants, steel dental implant and osteosynthesis material only applicable to the participants included in Lyon hospital center (n=15).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No