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

Spinal Cord Injury Clinical Trial

— ATLET  

Official title:

The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk? A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854555
• Other study ID #: 980924076
• Secondary ID: P REK 69/2008P R
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2020
• Source: North Norway Rehabilitation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Sunnaas Hospital	Oslo
Norway	North Norway Rehabilitation Center	Tromsø

Sponsors (8)

Lead Sponsor	Collaborator
North Norway Rehabilitation Center	Loma Linda University, Norwegian Department of Health and Social Affairs, Norwegian Foundation for Health and Rehabilitation, Norwegian School of Sport Sciences, Sunnaas Rehabilitation Hospital, University of Oslo, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patients with motor incomplete SCI are able to improve ADL function after locomotor training.		2 - 4 weeks before and after intervention
Primary	Locomotor training is cost-effective rehabilitation.		2-4 weeks before and after intervention
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in walking function		2-4 weeks before and after intervention
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency		2-4 weeks before and after intervention
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in balance		2-4 weeks before and after intervention
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities		2-4 weeks before and after intervention
Secondary	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
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale		2-4 weeks before and after intervention
Secondary	Locomotor training in persons with motor incomplete SCI will lead to change in quality of life		2-4 weeks before and after intervention
Secondary	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