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Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

NCT ID: NCT01087918

Last Updated: 2012-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injury

Keywords

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ASIA C and D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RAGT

Intervention Type DEVICE

16 sessions / 4 times/week / 45 minutes Lokomat training

Strength Training

Intervention Type OTHER

16 sessions / 4 times/week / 45 minutes lower extremity strength training

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.

Group Type EXPERIMENTAL

RAGT

Intervention Type DEVICE

16 sessions / 4 times/week / 45 minutes Lokomat training

Strength Training

Intervention Type OTHER

16 sessions / 4 times/week / 45 minutes lower extremity strength training

Interventions

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RAGT

16 sessions / 4 times/week / 45 minutes Lokomat training

Intervention Type DEVICE

Strength Training

16 sessions / 4 times/week / 45 minutes lower extremity strength training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huub van Hedel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Labruyere R, van Hedel HJ. Strength training versus robot-assisted gait training after incomplete spinal cord injury: a randomized pilot study in patients depending on walking assistance. J Neuroeng Rehabil. 2014 Jan 9;11:4. doi: 10.1186/1743-0003-11-4.

Reference Type DERIVED
PMID: 24401143 (View on PubMed)

Other Identifiers

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CLI006/2 extension

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EK-21/2008

Identifier Type: -

Identifier Source: org_study_id