- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01968096
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.
Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.
The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Stage 1 subjects: Spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury < 2 years
Stage 2 subjects: Incomplete spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of incomplete spinal cord injury
- ASIA classification:B, C, or D
Stage 3 subjects: Spinal cord injury subjects with high muscle tone
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury.
- ASIA classification: A, B, C, or D
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: SCI subjects
Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.
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Ingen indgriben: Incomplete SCI subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
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Ingen indgriben: Health subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
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Eksperimentel: SCI subjects with high muscle tone (High frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .
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A rehabilitation program of machine driven passive stretch.
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Eksperimentel: SCI subjects with high muscle tone(low frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
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A rehabilitation program of machine driven passive stretch.
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Ingen indgriben: SCI subjects with high muscle tone
Stage 3 subjects:Control subjects
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Clinical muscle tone tests & Peripheral nerve Stimulation machine
Tidsramme: Participants will be followed for the duration of invention, an expected average of 24 weeks.
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Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated. |
Participants will be followed for the duration of invention, an expected average of 24 weeks.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 102-1780C
- NSC102-2314-B-182-021-MY2
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