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Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT05200091
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Study Description
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Brief Summary:
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Combined explosive strength and specific balance training group Not Applicable

Detailed Description:

After obtaining their consent, participants will undertake evaluations at different times:

  1. Assessment 1 week prior to training
  2. Training over 4 weeks (nature of the training depends on the group)
  3. Assessment 1 week after training
  4. Assessment 1 month after training (follow-up)

Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:

  • Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
  • Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.

After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combined explosive strength and specific balance training group
This group will be formed with participants with incomplete spinal cord injury. This group will perform 4 weeks of combined explosive strength and specific balance training.
 Other: Combined explosive strength and specific balance training group

Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations.

Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements.

Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:

  • Forward tilt of base of support;
  • Backward tilt of base of support;
  • Translation forward;
  • Translation backward;
  • Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center.
No Intervention: Spinal cord injury control group
This group will be formed with participants with incomplete spinal cord injury. They will perform all the evaluation before and after a 4-week period of rest (no training).
No Intervention: Healthy control group
Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.


Outcome Measures
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Primary Outcome Measures :
  1. Change in muscles EMG responses following balance perturbation [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.

  2. Change in center of pressure displacement following balance perturbation using a force platform [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    Excursion of centre of pressure will be analyzed following forward and backward perturbation.

  3. Change in ankle muscle strength using force transducer [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.


Secondary Outcome Measures :
  1. Change in intracortical mechanisms using transcranial magnetic stimulation (TMS) [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms

  2. Change in the influence of peripheral afferents on cortical output using short-afference inhibition [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.

  3. Change in the modulation of the H reflex by the corticospinal tract [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.

  4. Change in EMG responses following vestibular stimulations during quiet standing [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    Galvanic vestibular stimulation will be triggered during quiet standing. EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.

  5. Change in the excursion of the center of pressure following vestibular stimulations [ Time Frame: Pre-intervention, immediately after and one-month after intervention ]
    Galvanic vestibular stimulation will be triggered during quiet standing. The displacement of the center of pressure will be analyzed using a force platform.


Other Outcome Measures:
  1. MOntreal Cognitive Assessment (MoCA) score [ Time Frame: Before enrollment ]
    The maximal score is 30 and minimal score 0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

FOR PARTICIPANTS WITH SPINAL CORD INJURY

Inclusion Criteria:

  • Have an incomplete lesion of spinal cord
  • Level of spinal cord lesion between C5 and T12
  • At least, 6 months post-injury
  • Be considered as AIS C or D
  • Be able to stand without support for 15 seconds
  • Be able to provide informed consent in English or in French

Exclusion Criteria:

  • To have cognitive deficits
  • To have personal or family history of epilepsy
  • To have suffered moderate or severe traumatic brain injury
  • To have cochlear implant

FOR CONTROL PARTICIPANTS

Exclusion Criteria:

  • To have orthopedics problems
  • To have cognitive deficits
  • To have neurological problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200091


Contacts
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Contact: Dorothy Barthélemy, PhD, PT 514-343-7712 dorothy.barthelemy@umontreal.ca

Locations
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Canada, Quebec
Neuromobility lab Recruiting
Montréal, Quebec, Canada
Contact: Dorothy Barthélemy, PhD, PT    514-343-7712    dorothy.barthelemy@umontreal.ca   
Sponsors and Collaborators
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
More Information
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Responsible Party: Dorothy Barthélemy, Associate professor and researcher, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
ClinicalTrials.gov Identifier: NCT05200091    
Other Study ID Numbers: CRIR 1325-0118
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal:
Combined explosive strength and balance training
Balance control
Corticospinal tract
Intracortical mechanisms
Vestibular system
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System