Locomotor Training in Persons With Multiple Sclerosis
1. juli 2016 opdateret af: Barbara Giesser, University of California, Los Angeles
Robotic Locomotor Training in Persons With Multiple Sclerosis
Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity.
It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy.
In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were suspended in a harness while in the Lokomat with full to partial body weight support as needed. After the training in the Lokomat, they practiced overground walking for 10 minutes.
The other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the Lokomat group for intensity, duration and frequency. they did not practice overground walking.
Primary outcome measure was speed to accomplish 25' timed walk.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095
- UCLA
-
-
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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device
Exclusion Criteria:
- Ataxia
- Unable to ambulate
- Within 3 months of exacerbation
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: 1
locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training.
Locomotor training will be done using the Lokomat device.
the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill.
|
locomotor training using body weight support on a treadmill
|
|
Aktiv komparator: 2
resistive training using weights and therabands
|
resistive training using theraband and/or weights
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Walking Speed as Assessed by 25' Timed Walk
Tidsramme: at beginning,mid point, end and 12 weeks after intervention
|
This is the time needed for participant to walk 25 feet.
Participant walks on a level surface.
the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.
|
at beginning,mid point, end and 12 weeks after intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Distance
Tidsramme: baseline, mid point, end and 12 weeks after training
|
distance assessed by 6 minute walk test
|
baseline, mid point, end and 12 weeks after training
|
|
Fatigue
Tidsramme: baseline, mid, completetion, 3 months post
|
fatigue assessed by modified fatigue impact scale.
This is a 21 item questionnaire which has a range from 0-84.
Higher scores indicate more impact of fatigue on physical and cognitive functioning.
|
baseline, mid, completetion, 3 months post
|
|
PASAT
Tidsramme: baseline, mid, completion, 3 months post training
|
Cognitive measure of attention and information processing speed.
Score goes from 0-60 with higher number indicating better performance.
Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance
|
baseline, mid, completion, 3 months post training
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Barbara S Giesser, MD, University of California, Los Angeles
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
- Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31. doi: 10.1177/1352458506070663.
- Giesser B, Herlihy E, Plummer D'Amato P et al. Randomized controlled trial of robotic locomotor training in persons with MS. Multiple Sclerosis Journal 17S481 ( 2011)
- Giesser B, Herlihy, E, PlummerD'Amato P, et al. Locomotor training may improve cognitive performance in persons with MS. Neurology 72 ( Suppl.3) A 405 (2009)
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
1. juli 2006
Primær færdiggørelse (Faktiske)
1. august 2009
Studieafslutning (Faktiske)
1. august 2009
Datoer for studieregistrering
Først indsendt
22. januar 2008
Først indsendt, der opfyldte QC-kriterier
4. februar 2008
Først opslået (Skøn)
5. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-04-064-02
- RG3724-A-4 (Anden identifikator: National MS Society)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .