Discrete Versus Rhythmic Gait Training
2 maj 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Sao Paulo, Brasilien, 05716-150
- Instituto de Medicina Física e Reabilitação - Lucy Montoro
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Functional Ambulation Scale (FAC)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Six-minute Walking Test (6MWT)
Tidsram: Baseline and 6 weeks
|
Change in distance of the gait applied test after intervention as compared to baseline
|
Baseline and 6 weeks
|
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Time Up and Go (TUG)
Tidsram: 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)
Tidsram: Baseline and 6 weeks
|
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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Daniel G Goroso, Doctor, University of Sao Paulo
- Studiestol: Lumy Sawaki, PhD, University of Kentucky
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2014
Primärt slutförande (Faktisk)
1 mars 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
5 januari 2016
Först inskickad som uppfyllde QC-kriterierna
6 januari 2016
Första postat (Uppskatta)
8 januari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Robotics in Stroke
Plan för individuella deltagardata (IPD)
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