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| ID | Type | Description | Link |
|---|---|---|---|
| P REK 69/2008 | |||
| P REK 2009-634 | Other Identifier | National Committee for Medical and Health Research Ethics |
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| Name | Class |
|---|---|
| Sunnaas Rehabilitation Hospital | OTHER |
| Norwegian School of Sport Sciences | OTHER |
| University of Tromso | OTHER |
| University of Oslo |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robot | Experimental | 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. |
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| manual assistance | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locomotor training with robot | Other | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ADL function and independency | 2-4 weeks before and after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Synnove F Knutsen, MD PhD | North Norway Rehabilitation Center | Principal Investigator |
| Raymond Knutsen, MD MPH | ATLET Steering group | Study Chair |
| Nils Hjeltnes, MD PhD | Sunnaas Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnaas Hospital | Oslo | 1450 | Norway | |||
| North Norway Rehabilitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31848443 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| OTHER |
| Norwegian Foundation for Health and Rehabilitation | OTHER |
| Norwegian Department of Health and Social Affairs | OTHER_GOV |
| Loma Linda University | OTHER |
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| Locomotor training with manual assistance | Other | 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. |
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| Locomotor training in persons with motor incomplete SCI will lead to change in balance | 2-4 weeks before and after intervention |
| 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 ASIA impairment scale | 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 |
| Tromsø |
| 9011 |
| Norway |
| D014947 | Wounds and Injuries |