The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? - Full Text View

Sponsors and Collaborators:	North Norway Rehabilitation Center Sunnaas Rehabilitation Hospital Friskverklinikken Norwegian School of Sport Sciences University of Tromso University of Oslo Norwegian Foundation for Health and Rehabilitation Norwegian Department of Health and Social Affairs
Information provided by:	North Norway Rehabilitation Center
ClinicalTrials.gov Identifier:	NCT00854555

Purpose

The ATLET study will assess the effect of manual or robotic body-weight supported locomotor training of patients with stable motor incomplete spinal cord injury (SCI) on gait and overall ADL function as well as on estimated health care costs.

Condition	Intervention
Incomplete Spinal Cord Injury	Other: Locomotor training with robot Other: Locomotor training with manual assistance

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by North Norway Rehabilitation Center:

Primary Outcome Measures:

To assess whether locomotor training with body-weight support in patients with motor incomplete SCI results in full or partial recovery of the ability to walk and/or stand. [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Patients with motor incomplete SCI are able to improve ADL function after locomotor training. [ Time Frame: 2 - 4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training is cost-effective rehabilitation. [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Locomotor training in persons with motor incomplete SCI will lead to change in walking function [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in balance [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in strenght in lower extrenities [ Time Frame: 2-4 weeks befoe and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in sensibility below the level of injury [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in quality of life [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
Locomotor training in persons with motor incomplete SCI will lead to change in use of personal assistant or home health nurse [ Time Frame: 2-4 weeks before and after intervenstion ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
robot: Experimental 30 persons with incomplete SCI who live within driving distance to Oslo and who meet the inclusion/exclusion criteria will be selected for randomization to robotic assisted training or control (conventional treatment).	Other: Locomotor training with robot 60 days locomotor training during 6 months periode in out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
manual assistance: Experimental 30 persons with incomplete SCI who live outside driving distance to Oslo and who meet inclusion/exclusion criteria will be selected for manually assisted training in Tromsø or control (conventional treatment).	Other: Locomotor training with manual assistance 60 days training during 6 months periode on in-patiest setting. Training 2 times per day total 120 minutes. Control group recieves conventional training/treatment.

Detailed Description:

There are approximately 100 new cases of spinal cord injuries (SCI) each year in Norway. Most of the SCI occur after traumatic accidents among young people and adults during the time of their productive life. Loss of walking and standing ability restricts their independent mobility and autonomy and severely impacts their quality of life.

The study has two arms: 1) manual locomotor training (Tromsø) and 2) robot assisted training (Oslo). Each study arm has 30 patients, randomized to receive standard care or intervention. The intervention group receives 60 days of intensive locomotor training over 6 months. Single-blind, before/after evaluation of effect will be performed at Sunnaas hospital using a standardized set of evaluation tools.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Motor incomplete SCI grade AIS-C or -D
Age: 18 - 65 years
Body mass index of <30
Wheelchair dependent
At least 2 years since time of injury
Cognitively unaffected and motivated for locomotor training
Lives within driving distance of Oslo (< 70 km), if considered for the outpatient arm of the study.

Exclusion Criteria:

Complete SCI grade AIS-A or -B
Cognitively reduced
BMI ≥ 30
Age: under 18 years or above 65 years
Spasms and contractures which can prevent locomotor training
Changes in use of spasm reducing medication during intervention
Significant osteoporosis in spine and/or joints
Pregnancy (adequate contraceptive use is required of women in fertile age)
Physical limitations for the use of the robotic orthosis
Participation in other intensive traininig programs
Those who live 70 or more kilometers from the Oslo training center, will be enrolled in the Tromso arm of the study.
Other medical condition which can interfere with the training protocol
Previous knee- or hip replacement

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854555

Locations

Norway
North Norway Rehabilitation Center
Tromsø, Norway, 9011
Friskvernklinikken
Asker, Norway, 1383
Sunnaas Hospital
Oslo, Norway, 1450

Sponsors and Collaborators

North Norway Rehabilitation Center

Sunnaas Rehabilitation Hospital

Friskverklinikken

Norwegian School of Sport Sciences

University of Tromso

University of Oslo

Norwegian Foundation for Health and Rehabilitation

Norwegian Department of Health and Social Affairs

Investigators

Principal Investigator:	Synnove F Knutsen, MD PhD	North Norway Rehabilitation Center
Study Chair:	Raymond Knutsen, MD MPH	ATLET Steering group
Principal Investigator:	Nils Hjeltnes, MD PhD	Sunnaas Hospital

More Information

No publications provided

Responsible Party:	North Norway Rehabilitation Center ( Synnøve Knutsen, MD, PhD, professor )
Study ID Numbers:	980924076, P REK 69/2008
Study First Received:	March 1, 2009
Last Updated:	March 1, 2009
ClinicalTrials.gov Identifier:	NCT00854555 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs; Norway: The National Committees for Research Ethics in Norway

Keywords provided by North Norway Rehabilitation Center:

incomplete spinal cord injury
locomotor activity
walking function
gait

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 11, 2009