NCT05200091

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

September 1, 2021

Last Update Submit

January 6, 2022

Conditions

Keywords

Combined explosive strength and balance trainingBalance controlCorticospinal tractIntracortical mechanismsVestibular system

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)

    Pre-intervention, immediately after and one-month after intervention

  • Change in the influence of peripheral afferents on cortical output using short-afference inhibition

    Pre-intervention, immediately after and one-month after intervention

  • Change in the modulation of the H reflex by the corticospinal tract

    Pre-intervention, immediately after and one-month after intervention

  • Change in EMG responses following vestibular stimulations during quiet standing

    Pre-intervention, immediately after and one-month after intervention

  • Change in the excursion of the center of pressure following vestibular stimulations

    Pre-intervention, immediately after and one-month after intervention

Other Outcomes (1)

  • MOntreal Cognitive Assessment (MoCA) score

    Before enrollment

Study Arms (3)

Combined explosive strength and specific balance training group

EXPERIMENTAL

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

Spinal cord injury control group

NO INTERVENTION

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 control group

NO INTERVENTION

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.

Interventions

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.

Combined explosive strength and specific balance training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • To have orthopedics problems
  • To have cognitive deficits
  • To have neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromobility lab

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Dorothy Barthélemy, PhD, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and researcher

Study Record Dates

First Submitted

September 1, 2021

First Posted

January 20, 2022

Study Start

July 9, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations