Status:
COMPLETED
The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?
Lead Sponsor:
North Norway Rehabilitation Center
Collaborating Sponsors:
Sunnaas Rehabilitation Hospital
Norwegian School of Sport Sciences
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 producti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00854555
Start Date
August 1 2008
End Date
January 31 2019
Last Update
September 11 2020
Active Locations (2)
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1
Sunnaas Hospital
Oslo, Norway, 1450
2
North Norway Rehabilitation Center
Tromsø, Norway, 9011