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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Sunnaas Rehabilitation Hospital
Friskvernklinikken
Norwegian School of Sport Sciences
University of Tromso
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
Information provided by (Responsible Party):
Synnove Knutsen, North Norway Rehabilitation Center
ClinicalTrials.gov Identifier:
NCT00854555
First received: March 1, 2009
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Incomplete Spinal Cord Injury
Other: Locomotor training with robot
Other: Locomotor training with manual assistance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by North Norway Rehabilitation Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Patients with motor incomplete SCI are able to improve ADL function after locomotor training. [ Time Frame: 2 - 4 weeks before and after intervention ] [ Designated as safety issue: No ]
  • Locomotor training is cost-effective rehabilitation. [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Locomotor training in persons with motor incomplete SCI will lead to change in walking function [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Locomotor training in persons with motor incomplete SCI will lead to change in balance [ Time Frame: 2-4 weeks before and after intervention ] [ Designated as safety issue: No ]
  • Locomotor training in persons with motor incomplete SCI will lead to change in strenght in lower extrenities [ Time Frame: 2-4 weeks befoe and after intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 intervenstion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other: Locomotor training with robot
60 days locomotor training during 6 months periode in out-patient setting. Minimum 60 min training up to 3 times per week. Control group receives conventional training/treatment.
Other Name: 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).
Other: Locomotor training with manual assistance
60 days training during 6 months periode on in-patiest setting. Training 2 times per day total 120 minutes. Control group recieves conventional training/treatment.
Other Names:
  • Vigor Equipment treadmill and suspension system
  • Therapist assisted

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Motor incomplete SCI grade AIS-C or -D
  • Age: 18 - 65 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 65 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 traininig 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854555

Locations
Norway
Friskvernklinikken
Asker, Norway, 1383
Sunnaas Hospital
Oslo, Norway, 1450
North Norway Rehabilitation Center
Tromsø, Norway, 9011
Sponsors and Collaborators
North Norway Rehabilitation Center
Sunnaas Rehabilitation Hospital
Friskvernklinikken
Norwegian School of Sport Sciences
University of Tromso
University of Oslo
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
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
  More Information

No publications provided

Responsible Party: Synnove Knutsen, MD, PhD, Professor, North Norway Rehabilitation Center
ClinicalTrials.gov Identifier: NCT00854555     History of Changes
Other Study ID Numbers: 980924076, P REK 69/2008
Study First Received: March 1, 2009
Last Updated: April 12, 2013
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Directorate of Health
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by North Norway Rehabilitation Center:
incomplete spinal cord injury
locomotor activity
walking function
gait

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 26, 2014