NCT00854555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

10.4 years

First QC Date

March 1, 2009

Last Update Submit

September 10, 2020

Conditions

Spinal Cord Injury

Keywords

incomplete spinal cord injurylocomotor activitywalking functiongait

Outcome Measures

Primary Outcomes (3)

  • 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

  • Patients with motor incomplete SCI are able to improve ADL function after locomotor training.

    2 - 4 weeks before and after intervention

  • Locomotor training is cost-effective rehabilitation.

    2-4 weeks before and after intervention

Secondary Outcomes (8)

  • Locomotor training in persons with motor incomplete SCI will lead to change in walking function

    2-4 weeks before and after intervention

  • Locomotor training in persons with motor incomplete SCI will lead to change in ADL function and independency

    2-4 weeks before and after intervention

  • Locomotor training in persons with motor incomplete SCI will lead to change in balance

    2-4 weeks before and after intervention

  • Locomotor training in persons with motor incomplete SCI will lead to change in strength in lower extremities

    2-4 weeks before and after intervention

  • 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

  • +3 more secondary outcomes

Study Arms (2)

robot

EXPERIMENTAL

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

manual assistance

EXPERIMENTAL

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

Interventions

Locomotor training with robotOTHER

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.

Also known as: LOKOMAT
robot
Locomotor training with manual assistanceOTHER

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.

Also known as: Vigor Equipment treadmill and suspension system, Therapist assisted
manual assistance

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnaas Hospital

Oslo, 1450, Norway

Location

North Norway Rehabilitation Center

Tromsø, 9011, Norway

Location

Related Publications (1)

  • 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.

    PMID: 31848443DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Synnove F Knutsen, MD PhD

    North Norway Rehabilitation Center

    PRINCIPAL INVESTIGATOR

  • Raymond Knutsen, MD MPH

    ATLET Steering group

    STUDY CHAIR

  • Nils Hjeltnes, MD PhD

    Sunnaas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

March 1, 2009

First Posted

March 3, 2009

Study Start

August 1, 2008

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations

NO(2)