- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04828252
Low Level Laser Intervention for Individuals With Knee Osteoarthritis
21. juni 2021 opdateret af: National Cheng-Kung University Hospital
The Effects of Low Level Laser Intervention on Muscular Strength for Individuals With Knee Osteoarthritis
The purpose of this study was to investigate the intervention effects of low level laser for knee OA group
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Tainan, Taiwan, 701
- Department of Physical Therapy, National Cheng-Kung University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3
Exclusion Criteria:
- Uncontrolled hypertension
- Malignant tumor
- Skin cancer
- Pregnant
- Dysesthesia
- Pacemaker inplement
- Cognitive problem
- Fall record within 6 months
- Dysfunction of blood coagulation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 808nm
The wavelength of this experimental group was 808nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
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The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
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Aktiv komparator: 660nm
The wavelength of this experimental group was 660nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
|
The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
|
Placebo komparator: Control
The wavelength of control group, total power: 0.0072W, 15 minutes a session, 3 times a week for 8 weeks
|
The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes of muscular strength of thigh measured by handheld dynamometer
Tidsramme: Baseline and after treatment, 8 weeks intervention
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Muscular strength of the knee extensor and flexor on both sides and will be normalized by the body weight of participants' (lb/kg)
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Baseline and after treatment, 8 weeks intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes of walking speed measured by the stop watch
Tidsramme: Baseline and after treatment, 8 weeks intervention
|
40-m walk test, participants are instructed to walk as fast as they could, investigator records the time they spend.
(seconds)
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Baseline and after treatment, 8 weeks intervention
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Changes of stair climbing ability measured by the stop watch
Tidsramme: Baseline and after treatment, 8 weeks intervention
|
stair climbing test, participants are instructed to climb stairs with a total height of 180 cm as fast as they could, investigator records the time they spend.
(seconds)
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Baseline and after treatment, 8 weeks intervention
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Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete
Tidsramme: Baseline and after treatment, 8 weeks intervention
|
sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete.
(times)
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Baseline and after treatment, 8 weeks intervention
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Changes of dynamic balance ability measured by the stop watch
Tidsramme: Baseline and after treatment, 8 weeks intervention
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timed UP&Go test, participants are instructed to stand up from a chair and walk as fast as they could for 3 meters and back to the chair, investigator records the time they spend.
(seconds)
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Baseline and after treatment, 8 weeks intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes of joint range of motion measured by the goniometer
Tidsramme: Baseline and after treatment, 8 weeks intervention
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Joint range of motion of the hip flexion, internal and external rotation, knee flexion, extension on both sides(degrees)
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Baseline and after treatment, 8 weeks intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Cheng-Feng Lin, Ph.D, Department of Physical Therapy, National Cheng-Kung University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. november 2020
Primær færdiggørelse (Faktiske)
4. juni 2021
Studieafslutning (Faktiske)
4. juni 2021
Datoer for studieregistrering
Først indsendt
3. februar 2021
Først indsendt, der opfyldte QC-kriterier
31. marts 2021
Først opslået (Faktiske)
2. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A-ER-109-187
Plan for individuelle deltagerdata (IPD)
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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