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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Locomotor training with robot
Locomotor training with manual assistance
Sponsored by
North Norway Rehabilitation Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring incomplete spinal cord injury, locomotor activity, walking function, gait

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sunnaas Hospital
  • North Norway Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

robot

manual assistance

Arm 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.

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.

Outcomes

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.
Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
Locomotor training is cost-effective rehabilitation.

Secondary Outcome Measures

Locomotor training in persons with motor incomplete SCI will lead to change in walking function
Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency
Locomotor training in persons with motor incomplete SCI will lead to change in balance
Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities
Locomotor training in persons with motor incomplete SCI will lead to change in sensibility below the level of injury
Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale
Locomotor training in persons with motor incomplete SCI will lead to change in quality of life
Locomotor training in persons with motor incomplete SCI will lead to change in use of personal assistant or home health nurse

Full Information

First Posted
March 1, 2009
Last Updated
September 10, 2020
Sponsor
North Norway Rehabilitation Center
Collaborators
Sunnaas Rehabilitation Hospital, Norwegian School of Sport Sciences, University of Tromso, University of Oslo, Norwegian Foundation for Health and Rehabilitation, Norwegian Department of Health and Social Affairs, Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT00854555
Brief Title
The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?
Acronym
ATLET
Official Title
The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Norway Rehabilitation Center
Collaborators
Sunnaas Rehabilitation Hospital, Norwegian School of Sport Sciences, University of Tromso, University of Oslo, Norwegian Foundation for Health and Rehabilitation, Norwegian Department of Health and Social Affairs, Loma Linda University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
incomplete spinal cord injury, locomotor activity, walking function, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
robot
Arm Type
Experimental
Arm 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.
Arm Title
manual assistance
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Locomotor training with robot
Other Intervention Name(s)
LOKOMAT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Locomotor training with manual assistance
Other Intervention Name(s)
Vigor Equipment treadmill and suspension system, Therapist assisted
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Patients with motor incomplete SCI are able to improve ADL function after locomotor training.
Time Frame
2 - 4 weeks before and after intervention
Title
Locomotor training is cost-effective rehabilitation.
Time Frame
2-4 weeks before and after intervention
Secondary Outcome Measure Information:
Title
Locomotor training in persons with motor incomplete SCI will lead to change in walking function
Time Frame
2-4 weeks before and after intervention
Title
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
Title
Locomotor training in persons with motor incomplete SCI will lead to change in balance
Time Frame
2-4 weeks before and after intervention
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Synnove F Knutsen, MD PhD
Organizational Affiliation
North Norway Rehabilitation Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond Knutsen, MD MPH
Organizational Affiliation
ATLET Steering group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nils Hjeltnes, MD PhD
Organizational Affiliation
Sunnaas Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Hospital
City
Oslo
ZIP/Postal Code
1450
Country
Norway
Facility Name
North Norway Rehabilitation Center
City
Tromsø
ZIP/Postal Code
9011
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31848443
Citation
Piira A, Lannem AM, Gjesdal K, Knutsen R, Jorgensen L, Glott T, Hjeltnes N, Knutsen SF, Sorensen M. Quality of life and psychological outcomes of body-weight supported locomotor training in spinal cord injured persons with long-standing incomplete lesions. Spinal Cord. 2020 May;58(5):560-569. doi: 10.1038/s41393-019-0401-2. Epub 2019 Dec 17.
Results Reference
derived

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

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