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

North Norway Rehabilitation Center44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Locomotor training with robotOTHER

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.

Locomotor training with manual assistanceOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Sunnaas Hospital

Oslo, Norway

North Norway Rehabilitation Center

Tromsø, Norway

Outcomes

Primary Outcomes

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.