Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
22 oktober 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 2
- Fas 1
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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Zurich, Schweiz, 8008
- Balgrist University Hospital
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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
16 år till 70 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
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Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
10 Meter Walking at Preferred Speed
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Walking Index for Spinal Cord Injury II
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Baseline, after intervention (4 weeks)
|
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Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
|
Falls Efficacy Scale
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Huub van Hedel, PhD, University of Zurich
Publikationer och användbara länkar
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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 juli 2009
Primärt slutförande (Faktisk)
1 september 2011
Avslutad studie (Faktisk)
1 september 2011
Studieregistreringsdatum
Först inskickad
15 mars 2010
Först inskickad som uppfyllde QC-kriterierna
15 mars 2010
Första postat (Uppskatta)
16 mars 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 oktober 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 oktober 2012
Senast verifierad
1 oktober 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EK-21/2008
- CLI006/2 extension (Annat bidrag/finansieringsnummer: Spinal Research)
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