Discrete Versus Rhythmic Gait Training
2. mai 2017 oppdatert av: Thais Amanda Rodrigues
Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke.
The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week.
Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed.
The novel approach of slowing down the treadmill reduced momentum.
If speed had been increased (standard approach), momentum would have increased (momentum = mass * velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait.
In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sao Paulo, Brasil, 05716-150
- Instituto de Medicina Física e Reabilitação - Lucy Montoro
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of stroke and image with hemiparesis left or right;
- No more that one ischemic or hemorrhagic stroke episode;
- 06 months post-stroke;
- Verified clinical stability on medical evaluation;
- Spasticity level I or II in the Ashworth scale;
- Score 1-2 in the Functional Ambulation Scale (FAC);
- Signed informed consent.
Exclusion Criteria:
- Dependence to perform activities of daily living before the stroke;
- Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
- Severe cognitive impairment;
- Serious psychiatric change that needs psychiatric care;
- Severe osteoporosis;
- Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
- Lack of resistance or disabling fatigue;
- Body weight greater than 150 kg;
- Unstable angina or other untreated heart disease;
- Chronic obstructive pulmonary disease;
- Unconsolidated fractures, pressure sores;
- Other neurological diseases.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Novel Protocol
Progressive decrease of speed and guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.0 km/h.
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All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
|
Eksperimentell: Standard Protocol
Progressive increase of speed and decrease of guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.9 km/h.
|
All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Ambulation Scale (FAC)
Tidsramme: Baseline and 6 weeks
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The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline. |
Baseline and 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Six-minute Walking Test (6MWT)
Tidsramme: Baseline and 6 weeks
|
Change in distance of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
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Time Up and Go (TUG)
Tidsramme: Baseline and 6 weeks
|
This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return.
This study compared the change in the time of the gait applied test after intervention as compared to baseline.
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Baseline and 6 weeks
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Ten-meters Walking Test (10MWT)
Tidsramme: Baseline and 6 weeks
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Change in the time of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
|
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Lower Limbs Fugl-Meyer
Tidsramme: Baseline and 6 weeks
|
The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment. This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline |
Baseline and 6 weeks
|
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Berg Scale
Tidsramme: Baseline and 6 weeks
|
Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance.
The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points.
A score below 45 is considered a fall risk.
This study comparede the change in the balance control applied scale after intervention as compared to baseline.
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Baseline and 6 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Daniel G Goroso, Doctor, University of Sao Paulo
- Studiestol: Lumy Sawaki, PhD, University of Kentucky
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2014
Primær fullføring (Faktiske)
1. mars 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
5. januar 2016
Først innsendt som oppfylte QC-kriteriene
6. januar 2016
Først lagt ut (Anslag)
8. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Robotics in Stroke
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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