Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury - Full Text View

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01087918

Purpose

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.

Condition	Intervention
- Incomplete Spinal Cord Injury	Device: Lokomat (driven gait orthosis) Other: Strength Training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effects of Automated Treadmill Training and Lower Extremity Strength Training on Walking-related and Other Outcomes in Subjects With Chronic Incomplete Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

10 meter walking speed (preferred and maximal) [ Time Frame: baseline, weekly during intervention, 6 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Walking Index for Spinal Cord Injury II [ Time Frame: see primary outcome measure ] [ Designated as safety issue: No ]
Berg Balance Scale [ Time Frame: onset, middle of intervention, end, follow up ] [ Designated as safety issue: No ]
Spinal Cord Independence Measure III [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
transcranial magnetic stimulation [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
manual muscle strength lower extremity [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
VAS pain [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
reaction time test [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
falls efficacy scale [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
figure of eight test [ Time Frame: onset, middle intervention, end, follow up ] [ Designated as safety issue: No ]
walking speed when walking a figure of eight und different conditions

Estimated Enrollment:	10
Study Start Date:	July 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Four weeks / 4 times / week / 45 minutes Lokomat training

Four weeks / 4 times / week / 45 minutes lower extremity strength training

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087918

Locations

Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008

Sponsors and Collaborators

University of Zurich

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	PD Dr. H. van Hedel, Rehabilitation Center Affoltern am Albis, University Children's Hospital Zurich
ClinicalTrials.gov Identifier:	NCT01087918 History of Changes
Other Study ID Numbers:	EK-21/2008, CLI006/2 extension
Study First Received:	March 15, 2010
Last Updated:	June 1, 2011
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Zurich:

ASIA C and D

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012