Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
22. oktober 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
9
Fase
- Fase 2
- Fase 1
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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-
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Zurich, Sveits, 8008
- Balgrist University Hospital
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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
16 år til 70 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
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16 sessions / 4 times/week / 45 minutes Lokomat training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
|
|
Eksperimentell: 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.
|
16 sessions / 4 times/week / 45 minutes Lokomat training
16 sessions / 4 times/week / 45 minutes lower extremity strength training
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
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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.
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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.
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Baseline, after intervention (4 weeks)
|
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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)
|
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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.
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Baseline, after intervention (4 weeks)
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Samarbeidspartnere og etterforskere
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Sponsor
Etterforskere
- Hovedetterforsker: Huub van Hedel, PhD, University of Zurich
Publikasjoner og nyttige lenker
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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. juli 2009
Primær fullføring (Faktiske)
1. september 2011
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
15. mars 2010
Først innsendt som oppfylte QC-kriteriene
15. mars 2010
Først lagt ut (Anslag)
16. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. oktober 2012
Sist bekreftet
1. oktober 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EK-21/2008
- CLI006/2 extension (Annet stipend/finansieringsnummer: Spinal Research)
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