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Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

22. oktober 2012 opdateret af: University of Zurich

Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury

The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

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

  • Schweiz
      • Zurich, Schweiz, 8008
        • Balgrist University Hospital

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

16 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Time since lesion > 1 year
  • Outdoor mobility SCIM III < 5
  • Stable walking capacity

Exclusion Criteria:

  • participating on other training studies
  • osteoporosis
  • psychiatric diseases
  • epilepsia
  • body weight > 130 kg
  • cardiac pacemaker

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: First RAGT, then strength training
16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
Enhed: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Andet: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
Eksperimentel: First strength training, then RAGT
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
Enhed: RAGT
16 sessions / 4 times/week / 45 minutes Lokomat training
Andet: Strength Training
16 sessions / 4 times/week / 45 minutes lower extremity strength training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10 Meter Walking at Preferred Speed
Tidsramme: Baseline, after intervention (4 weeks)
The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)
10 Meter Walking at Maximal Speed
Tidsramme: Baseline, after intervention (4 weeks)
The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Walking Index for Spinal Cord Injury II
Tidsramme: Baseline, after intervention (4 weeks)
The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)
Berg Balance Scale
Tidsramme: Baseline, after intervention (4 weeks)
The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)
Spinal Cord Independence Measure III
Tidsramme: Baseline, after intervention (4 weeks)
The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Tidsramme: Baseline, after intervention (4 weeks)
Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Baseline, after intervention (4 weeks)
Manual Muscle Test of the Lower Extremity
Tidsramme: Baseline, after intervention (4 weeks)
With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)
Pain on a Visual Analogue Scale
Tidsramme: Baseline, after intervention (4 weeks)
Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Baseline, after intervention (4 weeks)
Response Time of the Lower Extremities
Tidsramme: Baseline, after intervention (4 weeks)
We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Baseline, after intervention (4 weeks)
Falls Efficacy Scale
Tidsramme: Baseline, after intervention (4 weeks)
The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Baseline, after intervention (4 weeks)
Figure of Eight Test
Tidsramme: Baseline, after intervention (4 weeks)
The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Baseline, after intervention (4 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Huub van Hedel, PhD, University of Zurich

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

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 2009

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. september 2011

Datoer for studieregistrering

Først indsendt

15. marts 2010

Først indsendt, der opfyldte QC-kriterier

15. marts 2010

Først opslået (Skøn)

16. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EK-21/2008
  • CLI006/2 extension (Andet bevillings-/finansieringsnummer: Spinal Research)

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 .

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Kliniske forsøg med RAGT

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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