- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01726998
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients.
72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded.
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Seoul, Korea, Republikken, 120-752
- Severance Hospital
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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:
- Hemiparesis as result of 1st stroke
- No other neurologic or orthopedic disorder
- Independent ambulation before the stroke
- No severe medical illnesses
- Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups
- Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation
- The interval between stroke and start of the treatment
- Time since stroke onset < 6 months
- age: 20-80yrs old
Exclusion Criteria:
- Unstable fractures
- Severe osteoporosis
- Severe skin problems
- Severe joint problems
- Major difference in leg length,
- Body weight over 130 kg,
- Orthostatic circulatory problem
- Severe cognitive impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Lokomat Group
|
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically.
Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
|
Aktiv komparator: conventional gait training group
|
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically.
Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change of functional ambulation category point
Tidsramme: baseline, during training (2weeks), post training (4weeks) & followed for 2months after training
|
FAC is a functional walking test that evaluates ambulation ability.
This is an 6-point scale.
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baseline, during training (2weeks), post training (4weeks) & followed for 2months after training
|
Samarbejdspartnere og efterforskere
Sponsor
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
- 4-2012-0005
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