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Discrete Versus Rhythmic Gait Training

2 mei 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
      • Sao Paulo, Brazilië, 05716-150
        • Instituto de Medicina Física e Reabilitação - Lucy Montoro

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Novel Protocol
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.
Experimenteel: 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.
Procedure: Standard Protocol
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Ambulation Scale (FAC)
Tijdsspanne: Baseline and 6 weeks

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Six-minute Walking Test (6MWT)
Tijdsspanne: Baseline and 6 weeks
Change in distance of the gait applied test after intervention as compared to baseline
Baseline and 6 weeks
Time Up and Go (TUG)
Tijdsspanne: 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.
Baseline and 6 weeks
Ten-meters Walking Test (10MWT)
Tijdsspanne: Baseline and 6 weeks
Change in the time of the gait applied test after intervention as compared to baseline
Baseline and 6 weeks
Lower Limbs Fugl-Meyer
Tijdsspanne: 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
Berg Scale
Tijdsspanne: 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.
Baseline and 6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Thais Amanda Rodrigues

Onderzoekers

  • Studie stoel: Daniel G Goroso, Doctor, University of Sao Paulo
  • Studie stoel: Lumy Sawaki, PhD, University of Kentucky

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2014

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 september 2016

Studieregistratiedata

Eerst ingediend

5 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

6 januari 2016

Eerst geplaatst (Schatting)

8 januari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2017

Laatste update ingediend die voldeed aan QC-criteria

2 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Robotics in Stroke

Plan Individuele Deelnemersgegevens (IPD)

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