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

6 januari 2022 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Förväntat)

36

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Inget ingripande: 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).
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in muscles EMG responses following balance perturbation
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
MOntreal Cognitive Assessment (MoCA) score
Tidsram: Before enrollment
The maximal score is 30 and minimal score 0.
Before enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 juli 2018

Primärt slutförande (Förväntat)

1 december 2022

Avslutad studie (Förväntat)

1 december 2022

Studieregistreringsdatum

Först inskickad

1 september 2021

Först inskickad som uppfyllde QC-kriterierna

6 januari 2022

Första postat (Faktisk)

20 januari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CRIR 1325-0118

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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