An interventional study of Locomotor training with robot and Locomotor training with manual assistance in Spinal Cord Injury, sponsored by North Norway Rehabilitation Center. Completed at 2 sites in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by North Norway Rehabilitation Center · Not applicable, Interventional, and Treatment
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.
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 44 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with North Norway Rehabilitation Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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.
Also known as: LOKOMAT
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.
Also known as: Vigor Equipment treadmill and suspension system, Therapist assisted
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
Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
Time frame: 2 - 4 weeks before and after intervention
Locomotor training is cost-effective rehabilitation.
Time frame: 2-4 weeks before and after intervention
Locomotor training in persons with motor incomplete SCI will lead to change in walking function
Time frame: 2-4 weeks before and after intervention
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
Locomotor training in persons with motor incomplete SCI will lead to change in balance
Time frame: 2-4 weeks before and after intervention
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
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
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
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
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
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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