- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01418404
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.
There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kaohsiung city, Taiwan, 807
- Kaohsiung Medical University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- first-ever ischemic stroke;
- no severe cognitive impairments and able to follow instructions;
- sit on a chair for more than 30 minutes independently.
Exclusion Criteria:
- musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
- diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
- speech disorder or global aphasia;
- skin problems at the sites of stimulation;
6.contraindications of heat or ice application.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Noxious TS in study A
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hot, cold alternately, noxious TS in study A
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Aktiv komparator: Innocuous TS
Innocuous TS in study A
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warm, cool alternately, Innocuious TS in study A
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Eksperimentel: High Frequency of Noxious TS
High Frequency of Noxious TS in study B
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High Frequency of Noxious TS in study B
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Aktiv komparator: Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
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Low Frequency of Noxious TS in study B
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Eksperimentel: High Intensity of Noxious TS
High Intensity of Noxious TS in study C
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High Intensity of Noxious TS in study C
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Aktiv komparator: Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C
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Low Intensity of Noxious TS in study C
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Movement performance assessment
Tidsramme: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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Brain images
Tidsramme: immediate effects in 3 timeline
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immediate effects in 3 timeline
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Mapping of brain cortex
Tidsramme: immediate effect in four timeline
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immediate effect in four timeline
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Kinematics measure of upper extremity movement
Tidsramme: four timeline
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four timeline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of life
Tidsramme: baseline, post-intervention, 6 month follow-up
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baseline, post-intervention, 6 month follow-up
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jau-Hong Lin, Professor, Kaohsiung Medical University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NHRI-EX99-9907PI
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