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

6 gennaio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Anticipato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Nessun intervento: 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).
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in muscles EMG responses following balance perturbation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
MOntreal Cognitive Assessment (MoCA) score
Lasso di tempo: Before enrollment
The maximal score is 30 and minimal score 0.
Before enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 luglio 2018

Completamento primario (Anticipato)

1 dicembre 2022

Completamento dello studio (Anticipato)

1 dicembre 2022

Date di iscrizione allo studio

Primo inviato

1 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

6 gennaio 2022

Primo Inserito (Effettivo)

20 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRIR 1325-0118

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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