Clinical trial NCT00854555: The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?
Official title: The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: incomplete spinal cord injury
locomotor activity
walking function
gait
Lead sponsor: North Norway Rehabilitation Center
Sponsor class: OTHER
Collaborators: name: Sunnaas Rehabilitation Hospital
name: Norwegian School of Sport Sciences
name: University of Tromso
name: University of Oslo
name: Norwegian Foundation for Health and Rehabilitation
name: Norwegian Department of Health and Social Affairs
name: Loma Linda University
First posted: 2009-03-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 2-4 weeks before and after intervention
measure: Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
timeFrame: 2 - 4 weeks before and after intervention
measure: Locomotor training is cost-effective rehabilitation.
timeFrame: 2-4 weeks before and after intervention
Secondary outcomes:
measure: Locomotor training in persons with motor incomplete SCI will lead to change in walking function
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in balance
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in sensibility below the level of injury
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in quality of life
timeFrame: 2-4 weeks before and after intervention
measure: Locomotor training in persons with motor incomplete SCI will lead to change in use of personal assistant or home health nurse
timeFrame: 2-4 weeks before and after intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Sunnaas Hospital
city: Tromsø
country: Norway
facility: North Norway Rehabilitation Center
Study officials:
affiliation: North Norway Rehabilitation Center
name: Synnove F Knutsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ATLET Steering group
name: Raymond Knutsen, MD MPH
role: STUDY_CHAIR
affiliation: Sunnaas Hospital
name: Nils Hjeltnes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piira A, Lannem AM, Gjesdal K, Knutsen R, Jorgensen L, Glott T, Hjeltnes N, Knutsen SF, Sorensen M. Quality of life and psychological outcomes of body-weight supported locomotor training in spinal cord injured persons with long-standing incomplete lesions. Spinal Cord. 2020 May;58(5):560-569. doi: 10.1038/s41393-019-0401-2. Epub 2019 Dec 17.