The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: Locomotor training with robot
* Other: Locomotor training with manual assistance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robot<br>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<br>* 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.<br>* Other names: LOKOMAT;|
| Experimental: manual assistance<br>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<br>* 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.<br>* Other names: Therapist assisted;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incomplete spinal cord injury, locomotor activity, walking function, gait