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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Combined explosive strength and specific balance training group
Sponsored by
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Combined explosive strength and balance training, Balance control, Corticospinal tract, Intracortical mechanisms, Vestibular system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neuromobility labRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Combined explosive strength and specific balance training group

Spinal cord injury control group

Healthy control group

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Change in muscles EMG responses following balance perturbation
Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
Change in center of pressure displacement following balance perturbation using a force platform
Excursion of centre of pressure will be analyzed following forward and backward perturbation.
Change in ankle muscle strength using force transducer
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

Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
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.
Change in the modulation of the H reflex by the corticospinal tract
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.
Change in EMG responses following vestibular stimulations during quiet standing
Galvanic vestibular stimulation will be triggered during quiet standing. EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
Change in the excursion of the center of pressure following vestibular stimulations
Galvanic vestibular stimulation will be triggered during quiet standing. The displacement of the center of pressure will be analyzed using a force platform.

Full Information

First Posted
September 1, 2021
Last Updated
January 6, 2022
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT05200091
Brief Title
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
After obtaining their consent, participants will undertake evaluations at different times: Assessment 1 week prior to training Training over 4 weeks (nature of the training depends on the group) Assessment 1 week after training 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Combined explosive strength and balance training, Balance control, Corticospinal tract, Intracortical mechanisms, Vestibular system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined explosive strength and specific balance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Spinal cord injury control group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Combined explosive strength and specific balance training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscles EMG responses following balance perturbation
Description
Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in center of pressure displacement following balance perturbation using a force platform
Description
Excursion of centre of pressure will be analyzed following forward and backward perturbation.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in ankle muscle strength using force transducer
Description
Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Secondary Outcome Measure Information:
Title
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Description
A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Description
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.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in the modulation of the H reflex by the corticospinal tract
Description
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.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in EMG responses following vestibular stimulations during quiet standing
Description
Galvanic vestibular stimulation will be triggered during quiet standing. EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Title
Change in the excursion of the center of pressure following vestibular stimulations
Description
Galvanic vestibular stimulation will be triggered during quiet standing. The displacement of the center of pressure will be analyzed using a force platform.
Time Frame
Pre-intervention, immediately after and one-month after intervention
Other Pre-specified Outcome Measures:
Title
MOntreal Cognitive Assessment (MoCA) score
Description
The maximal score is 30 and minimal score 0.
Time Frame
Before enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorothy Barthélemy, PhD, PT
Phone
514-343-7712
Email
dorothy.barthelemy@umontreal.ca
Facility Information:
Facility Name
Neuromobility lab
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Barthélemy, PhD, PT
Phone
514-343-7712
Email
dorothy.barthelemy@umontreal.ca

12. IPD Sharing Statement

Learn more about this trial

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

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