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The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? (ATLET)

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ClinicalTrials.gov Identifier: NCT00854555
Recruitment Status : Active, not recruiting
First Posted : March 3, 2009
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
Sunnaas Rehabilitation Hospital
Norwegian School of Sport Sciences
University of Tromso
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
Loma Linda University
Information provided by (Responsible Party):
Synnove Knutsen, North Norway Rehabilitation Center

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Other: Locomotor training with robot Other: Locomotor training with manual assistance Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial
Study Start Date : August 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: robot
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). Intervention consists of locomotor training with robot for 60 days during 6 months period in an out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
Other: Locomotor training with robot
60 days locomotor training during 6 months period in out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
Other Name: LOKOMAT

Experimental: manual assistance
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). Intervention consists of 60 days locomotor training with manual assistance during 6 months period in an in-patient setting. Training 2 times per day total 120 minutes. Control group receives conventional training/treatment.
Other: Locomotor training with manual assistance
60 days training during 6 months period on in-patient setting. Training 2 times per day total 120 minutes. Control group receives conventional training/treatment.
Other Names:
  • Vigor Equipment treadmill and suspension system
  • Therapist assisted




Primary Outcome Measures :
  1. 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 ]
  2. Patients with motor incomplete SCI are able to improve ADL function after locomotor training. [ Time Frame: 2 - 4 weeks before and after intervention ]
  3. Locomotor training is cost-effective rehabilitation. [ Time Frame: 2-4 weeks before and after intervention ]

Secondary Outcome Measures :
  1. Locomotor training in persons with motor incomplete SCI will lead to change in walking function [ Time Frame: 2-4 weeks before and after intervention ]
  2. 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 ]
  3. Locomotor training in persons with motor incomplete SCI will lead to change in balance [ Time Frame: 2-4 weeks before and after intervention ]
  4. Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities [ Time Frame: 2-4 weeks before and after intervention ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 intervention ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Motor incomplete SCI grade AIS-C or -D
  • Age: 18 - 70 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 71 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 training 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854555


Locations
Norway
Sunnaas Hospital
Oslo, Norway, 1450
North Norway Rehabilitation Center
Tromsø, Norway, 9011
Sponsors and Collaborators
North Norway Rehabilitation Center
Sunnaas Rehabilitation Hospital
Norwegian School of Sport Sciences
University of Tromso
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
Loma Linda University
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

Responsible Party: Synnove Knutsen, MD, PhD, Professor, North Norway Rehabilitation Center
ClinicalTrials.gov Identifier: NCT00854555     History of Changes
Other Study ID Numbers: 980924076
P REK 69/2008
P REK 2009-634 ( Other Identifier: National Committee for Medical and Health Research Ethics )
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Keywords provided by Synnove Knutsen, North Norway Rehabilitation Center:
incomplete spinal cord injury
locomotor activity
walking function
gait

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System