- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07738978
Understanding and Enhancing Human Health and Movement
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance.
This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence.
A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Maura Malenchek, PTA
- Telefonnummer: 64989 216-791-3800
- E-mail: maura.malenchek@va.gov
Undersøgelse Kontakt Backup
- Navn: Lisa Lombardo, MPT
- Telefonnummer: 64909 2167913800
- E-mail: lisa.lombardo2@va.gov
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- Louis Stokes Cleveland VA Medical Center
-
Kontakt:
- Maura Malenchek
- Telefonnummer: 64989 2167913800
- E-mail: maura.malenchek@va.gov
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Skeletal maturity and ability to sign informed consent (>18 years)
- Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Time post injury greater than six months
- Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- Neurologically stable as determined by a physician
Exclusion Criteria:
- Non-English speaking
- Females who are pregnant
- Current pressure injuries that would be exacerbated by study activities
- Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
- History of spontaneous fractures or other evidence of excessively low bone density
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
- Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension
- Presence of a demand pacemaker or cardiac defibrillator
- Any other medical or psychological condition that would be a contraindication
- Current pressure ulcers
- Significant range of motion limitations that would compromise study activities
- Body habitus that would compromise study activities
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Neural Stimulation
This phase includes the use of neural (electrical) stimulation during everyday activities such as sitting, standing, walking, and exercise
|
implanted electrical stimulation device
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Difference in Max Standing Time
Tidsramme: Study completion - an average of 1 year
|
Study completion - an average of 1 year
|
|
Difference in Max Walking distance
Tidsramme: Study completion - an average of 1 year
|
Study completion - an average of 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Sår og skader
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Hjerneiskæmi
- Demyeliniserende autoimmune sygdomme, CNS
- Autoimmune sygdomme i nervesystemet
- Demyeliniserende sygdomme
- Traumer, nervesystemet
- Rygmarvssygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Slag
- Iskæmisk angreb, forbigående
- Multipel sclerose
- Rygmarvsskader
- Lammelse
- Udstyr og forsyninger
- Elektroder
- Elektrisk udstyr og forsyninger
- Elektroder, implanteret
- Proteser og implantater
- Implanterbare neurostimulatorer
- Neurale Proteser
Andre undersøgelses-id-numre
- 1591730
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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