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

September 10, 2020 updated by: Synnove Knutsen, North Norway Rehabilitation Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 1450
        • Sunnaas Hospital
      • Tromsø, Norway, 9011
        • North Norway Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: robot
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
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
EXPERIMENTAL: manual assistance
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention
Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
Time Frame: 2 - 4 weeks before and after intervention
2 - 4 weeks before and after intervention
Locomotor training is cost-effective rehabilitation.
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Locomotor training in persons with motor incomplete SCI will lead to change in walking function
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention
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
2-4 weeks before and after intervention
Locomotor training in persons with motor incomplete SCI will lead to change in balance
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention
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
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
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention
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
2-4 weeks before and after intervention
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
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
Time Frame: 2-4 weeks before and after intervention
2-4 weeks before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Norway Rehabilitation Center

Collaborators

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

Investigators

  • Principal Investigator: Synnove F Knutsen, MD PhD, North Norway Rehabilitation Center
  • Study Chair: Raymond Knutsen, MD MPH, ATLET Steering group
  • Principal Investigator: Nils Hjeltnes, MD PhD, Sunnaas Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2008

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

March 1, 2009

First Submitted That Met QC Criteria

March 1, 2009

First Posted (ESTIMATE)

March 3, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980924076
  • P REK 69/2008
  • P REK 2009-634 (OTHER: National Committee for Medical and Health Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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