- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03194464
Fatiguing Arm Exercise Following Stroke
Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Panoramica dello studio
Descrizione dettagliata
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.
The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:
- . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
- . Behavioral effects using a motor task involving manipulation and dexterity.
- . Determine the persistence and consistency of neural and behavioral facilitation.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
- Non-Veteran Participants are eligible
Exclusion Criteria:
- multiple strokes
- strokes in both hemispheres
- brainstem/medullary/cerebellar stroke
- seizure disorder
- metal implants in head or neck
- pacemaker or other implanted device
- inability to produce any measurable grip force
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Task-failure, Extended Session
Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period
|
participants perform repeated gripping with visual feedback to task failure
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Short Intracortical Inhibition (SICI)
Lasso di tempo: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
|
baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI Ratio
Lasso di tempo: Baseline, pre-exercise of 8 repeated sessions
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
|
Baseline, pre-exercise of 8 repeated sessions
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Box and Blocks Test (BBT)
Lasso di tempo: baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
Box and Blocks Test (BBT)
Lasso di tempo: baseline, pre-exercise of 8 repeated sessions
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
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baseline, pre-exercise of 8 repeated sessions
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Carolynn Patten, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- N1759-P
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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