Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

May 23, 2019 updated by: Hospices Civils de Lyon
Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

      • Saint-Genis-Laval, France, 69230
        • Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-55 years old,
  • quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,
  • complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,
  • post-traumatic period >6 months (since a motor recovery plateau is usually reached at 6-month post-SCI

Exclusion Criteria:

  • non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),
  • cerebral damage and/or cognitive deficit,
  • elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,
  • participation to another study
  • presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C6-C7 patients
C6-C7 patients able to recover tenodesis grasp.
Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).
Experimental: C5-C6 patients
C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation
Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).
No Intervention: Control group
a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor imagery ability
Time Frame: 10 weeks
Motor imagery ability assessed by magnetoencephalography measurements
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement time (MT)
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: movement time (MT)
10 weeks
absolute time to peak velocity
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: absolute time to peak velocity
10 weeks
movement amplitude at peak velocity
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity
10 weeks
time to opening
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: time to opening
10 weeks
time to maximal opening
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: time to maximal opening
10 weeks
amplitude of maximal opening
Time Frame: 10 weeks
Kinematic parameters of movement: temporal parameters: amplitude of maximal opening
10 weeks
Trajectory of movement measured in the XY plane
Time Frame: 10 weeks
Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane
10 weeks
height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
Time Frame: 10 weeks
Kinematic parameters of movement: spatial parameters: height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane
10 weeks
muscular force evaluated by muscle testing performed by a physiotherapist
Time Frame: 10 weeks
muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5)
10 weeks
joint amplitude evaluated in degrees (°) by the physiotherapist
Time Frame: 10 weeks
10 weeks
Box and Block test
Time Frame: 10 weeks
Box and Block test performed by an occupational therapist
10 weeks
Minnesota test.
Time Frame: 10 weeks
Minnesota test performed by an occupational therapist
10 weeks
amplitude of electrodermal responses
Time Frame: 10 weeks
mental chronometric assessment associated with acquisition of electrodermal responses
10 weeks
duration of electrodermal responses
Time Frame: 10 weeks
mental chronometric assessment associated with acquisition of electrodermal responses
10 weeks
Kinesthetic and Visual Imagery Questionnaire
Time Frame: 10 weeks
The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients
10 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gilles RODE, Pr, Hospices Civils de Lyon

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.

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

February 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

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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