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

North Norway Rehabilitation Center

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Other: Locomotor training with manual assistance; Other: Locomotor training with robot

Study type: Interventional

Funder types: Other

Identifiers

NCT00854555

P REK 69/2008

P REK 2009-634 (Other Identifier)

980924076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

robot

Experimental group

Description:

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.

Treatment:

Other: Locomotor training with robot

manual assistance

Experimental group

Description:

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.

Treatment:

Other: Locomotor training with manual assistance