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Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke

9. februar 2020 opdateret af: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke

Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Functional ambulation category score 3
  • 3 months ≤ Onset ≤ 12 months
  • Korean Mini-Mental State Examination score > 24

Exclusion Criteria:

  • History of surgery of affected lower limb
  • Fracture of affected lower limb

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Robot-assisted gait training
experimental group that applied the end-effector robot-assisted gait training
Enhed: Robot-assisted gait training
intervention with robot-assisted gait training
Aktiv komparator: Treadmill gait training
control group that applied the treadmill gait training
Enhed: Treadmill gait training
intervention with treadmill gait training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
oxygenated hemoglobin levels
Tidsramme: 4 weeks from baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
4 weeks from baseline
Range of motion of ankle, knee, and hip joint
Tidsramme: 4 weeks from baseline
ankle, knee, and hip joint motion of sagittal plane during gait
4 weeks from baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
oxygenated hemoglobin levels
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Range of motion of ankle, knee, and hip joint
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
ankle, knee, and hip joint motion of sagittal plane during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Berg Balance Scale
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
10m walk test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional ambulation category
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Falls efficacy scale
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck depression inventory
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Dynamic gait index
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
a clinical tool to assess gait, balance and fall risk
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timed up and go test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
a simple test used to assess a person's mobility and requires both static and dynamic balance
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - COWAT
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
dual task - digit span test
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
The digit span test is a way of measuring the storage capacity of a person's working memory.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Electromyography of lower extremities
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Plantar pressure
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Spatiotemporal gait parameter data
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
step length, step time, swing time, double limb support time during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
deoxygenated hemoglobin levels
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
total hemoglobin levels
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Balance test using force plate
Tidsramme: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Rehabilitation Center, Seoul, Korea

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. september 2018

Primær færdiggørelse (Faktiske)

30. november 2019

Studieafslutning (Faktiske)

31. december 2019

Datoer for studieregistrering

Først indsendt

12. august 2019

Først indsendt, der opfyldte QC-kriterier

12. august 2019

Først opslået (Faktiske)

13. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NRC-2017-02-015

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