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

NCT ID: NCT00854555

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2019-01-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Locomotor training with robot

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Locomotor training with manual assistance

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

LOKOMAT; Vigor Equipment treadmill and suspension system; Therapist assisted

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role: collaborator

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: collaborator

North Norway Rehabilitation Center

OTHER

Sponsor Role: lead

Responsible Party

Synnove Knutsen

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Synnove F Knutsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

North Norway Rehabilitation Center

Raymond Knutsen, MD MPH

Role: STUDY_CHAIR

ATLET Steering group

Nils Hjeltnes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnaas Hospital

Locations

Sunnaas Hospital

Oslo, , Norway

North Norway Rehabilitation Center

Tromsø, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 31848443 (View on PubMed)

Other Identifiers

P REK 69/2008

Identifier Type: -

Identifier Source: secondary_id

P REK 2009-634

Identifier Type: OTHER

Identifier Source: secondary_id

980924076

Identifier Type: -

Identifier Source: org_study_id