The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?
This study is enrolling participants by invitation only.
Sponsor:
North Norway Rehabilitation Center
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
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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:
|
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
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 Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013