- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05200091
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- Assessment 1 week after training
- 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).
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dorothy Barthélemy, PhD, PT
- Telefonní číslo: 514-343-7712
- E-mail: dorothy.barthelemy@umontreal.ca
Studijní místa
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-
Quebec
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Montréal, Quebec, Kanada
- Nábor
- Neuromobility lab
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Kontakt:
- Dorothy Barthélemy, PhD, PT
- Telefonní číslo: 514-343-7712
- E-mail: dorothy.barthelemy@umontreal.ca
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
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:
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Žádný zásah: 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).
|
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in muscles EMG responses following balance perturbation
Časové okno: Pre-intervention, immediately after and one-month after intervention
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Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
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Pre-intervention, immediately after and one-month after intervention
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Change in center of pressure displacement following balance perturbation using a force platform
Časové okno: Pre-intervention, immediately after and one-month after intervention
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Excursion of centre of pressure will be analyzed following forward and backward perturbation.
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Pre-intervention, immediately after and one-month after intervention
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Change in ankle muscle strength using force transducer
Časové okno: Pre-intervention, immediately after and one-month after intervention
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Časové okno: 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
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Pre-intervention, immediately after and one-month after intervention
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Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Časové okno: Pre-intervention, immediately after and one-month after intervention
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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.
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Pre-intervention, immediately after and one-month after intervention
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Change in the modulation of the H reflex by the corticospinal tract
Časové okno: Pre-intervention, immediately after and one-month after intervention
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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.
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Pre-intervention, immediately after and one-month after intervention
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Change in EMG responses following vestibular stimulations during quiet standing
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
MOntreal Cognitive Assessment (MoCA) score
Časové okno: Before enrollment
|
The maximal score is 30 and minimal score 0.
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Before enrollment
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CRIR 1325-0118
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