Spinal Cord Injury
Conditions
Keywords
incomplete spinal cord injury, locomotor activity, walking function, gait
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.
Interventions
OTHERLocomotor 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.
OTHERLocomotor 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.
Sponsors
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
North Norway Rehabilitation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2-4 weeks before and after intervention |
| Patients with motor incomplete SCI are able to improve ADL function after locomotor training. | 2 - 4 weeks before and after intervention |
| Locomotor training is cost-effective rehabilitation. | 2-4 weeks before and after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in sensibility below the level of injury | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in walking function | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in quality of life | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in use of personal assistant or home health nurse | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency | 2-4 weeks before and after intervention |
| Locomotor training in persons with motor incomplete SCI will lead to change in balance | 2-4 weeks before and after intervention |
Countries
Norway
Outcome results
None listed