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Completed

NCT Number: NCT00854555

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnaas Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LOKOMAT

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.

Other names: Vigor Equipment treadmill and suspension system, Therapist assisted

Primary outcomes

  1. 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

  2. Patients with motor incomplete SCI are able to improve ADL function after locomotor training.

    Time frame: 2 - 4 weeks before and after intervention

  3. Locomotor training is cost-effective rehabilitation.

    Time frame: 2-4 weeks before and after intervention

Secondary outcomes

  1. Locomotor training in persons with motor incomplete SCI will lead to change in walking function

    Time frame: 2-4 weeks before and after intervention

  2. 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

  3. Locomotor training in persons with motor incomplete SCI will lead to change in balance

    Time frame: 2-4 weeks before and after intervention

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

North Norway Rehabilitation Center

Other

Collaborators

  • Loma Linda University
  • Norwegian Department of Health and Social Affairs
  • Norwegian Foundation for Health and Rehabilitation
  • Norwegian School of Sport Sciences
  • Sunnaas Rehabilitation Hospital
  • University of Oslo
  • University of Tromso

Registry information

Official study title

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

Acronym: ATLET

Important dates

Study start
2008
Primary completion
2018
Study completion
2019
First posted
Mar 3, 2009
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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