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

• Sponsor: North Norway Rehabilitation Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00854555
• Collaborator: Sunnaas Rehabilitation Hospital (Other), Norwegian School of Sport Sciences (Other), University of Tromso (Other), University of Oslo (Other), Norwegian Foundation for Health and Rehabilitation (Other), Norwegian Department of Health and Social Affairs (Other), Loma Linda University (Other)
• Enrollment: 44
• Locations: 2
• Arms: 2
• Actual Duration (Months): 126
• Patients Per Site: 22
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Other: Locomotor training with robot; Other: Locomotor training with manual assistance	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial
• Actual Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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. [2-4 weeks before and after intervention]

2. Patients with motor incomplete SCI are able to improve ADL function after locomotor training. [2 - 4 weeks before and after intervention]

3. Locomotor training is cost-effective rehabilitation. [2-4 weeks before and after intervention]

Secondary Outcome Measures

1. Locomotor training in persons with motor incomplete SCI will lead to change in walking function [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 [2-4 weeks before and after intervention]

3. Locomotor training in persons with motor incomplete SCI will lead to change in balance [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 [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 [2-4 weeks before and after intervention]

6. Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale [2-4 weeks before and after intervention]

7. Locomotor training in persons with motor incomplete SCI will lead to change in quality of life [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 [2-4 weeks before and after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnaas Hospital	Oslo		Norway	1450
2	North Norway Rehabilitation Center	Tromsø		Norway	9011

Sponsors and Collaborators

• North Norway Rehabilitation Center
• 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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synnove Knutsen, MD, PhD, Professor, North Norway Rehabilitation Center
• ClinicalTrials.gov Identifier: NCT00854555
• Other Study ID Numbers: 980924076; P REK 69/2008; P REK 2009-634
• First Posted: Mar 3, 2009
• Last Update Posted: Sep 11, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Synnove Knutsen, MD, PhD, Professor, North Norway Rehabilitation Center: incomplete spinal cord injury; locomotor activity; walking function; gait
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Sep 11, 2020