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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200091
• Other study ID #: CRIR 1325-0118
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Contact: Dorothy Barthélemy, PhD, PT
• Phone: 514-343-7712
• Email: dorothy.barthelemy[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Neuromobility lab	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MOntreal Cognitive Assessment (MoCA) score	The maximal score is 30 and minimal score 0.	Before enrollment
Primary	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.	Pre-intervention, immediately after and one-month after intervention
Primary	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.	Pre-intervention, immediately after and one-month after intervention
Primary	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.	Pre-intervention, immediately after and one-month after intervention
Secondary	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	Pre-intervention, immediately after and one-month after intervention
Secondary	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.	Pre-intervention, immediately after and one-month after intervention
Secondary	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.	Pre-intervention, immediately after and one-month after intervention
Secondary	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.	Pre-intervention, immediately after and one-month after intervention
Secondary	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.	Pre-intervention, immediately after and one-month after intervention