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

6 januari 2022 bijgewerkt door: Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Verwacht)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Geen tussenkomst: 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).
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in muscles EMG responses following balance perturbation
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention
Change in center of pressure displacement following balance perturbation using a force platform
Tijdsspanne: Pre-intervention, immediately after and one-month after intervention
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
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Tijdsspanne: 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
Pre-intervention, immediately after and one-month after intervention
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention
Change in the modulation of the H reflex by the corticospinal tract
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention
Change in EMG responses following vestibular stimulations during quiet standing
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention
Change in the excursion of the center of pressure following vestibular stimulations
Tijdsspanne: 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.
Pre-intervention, immediately after and one-month after intervention

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MOntreal Cognitive Assessment (MoCA) score
Tijdsspanne: Before enrollment
The maximal score is 30 and minimal score 0.
Before enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juli 2018

Primaire voltooiing (Verwacht)

1 december 2022

Studie voltooiing (Verwacht)

1 december 2022

Studieregistratiedata

Eerst ingediend

1 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

6 januari 2022

Eerst geplaatst (Werkelijk)

20 januari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

6 januari 2022

Laatst geverifieerd

1 januari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CRIR 1325-0118

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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