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Spinal Cord InjuryATLETNCT00854555

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

A study testing Locomotor training with robot and Locomotor training with manual assistance in people with Spinal Cord Injury, run by North Norway Rehabilitation Center at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Locomotor training with robot and Locomotor training with manual assistance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesNorway
Study dates
Aug 2008to 31 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Sunnaas Hospital

    Oslo, 1450

  • North Norway Rehabilitation Center

    Tromsø, 9011

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Locomotor training with robot, Locomotor training with manual assistance
Keywords
incomplete spinal cord injury, locomotor activity, walking function, gait
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Locomotor training with robotOther

    Also called LOKOMAT

    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 assistanceOther

    Also called Vigor Equipment treadmill and suspension system, Therapist assisted

    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.

Study groups in NCT00854555
Study groupRoleWhat they receive
robotExperimental30 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.
Receives: Other: Locomotor training with robot
manual assistanceExperimental30 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.
Receives: Other: Locomotor training with manual assistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2-4 weeks before and after intervention

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

    Measured: 2 - 4 weeks before and after intervention

  3. Locomotor training is cost-effective rehabilitation.

    Measured: 2-4 weeks before and after intervention

Secondary outcomes (8)

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

    Measured: 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

    Measured: 2-4 weeks before and after intervention

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

    Measured: 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

    Measured: 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

    Measured: 2-4 weeks before and after intervention

  6. Locomotor training in persons with motor incomplete SCI will lead to change in ASIA impairment scale

    Measured: 2-4 weeks before and after intervention

  7. Locomotor training in persons with motor incomplete SCI will lead to change in quality of life

    Measured: 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

    Measured: 2-4 weeks before and after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2009 (estimated)
  2. Study startAug 2008
  3. Primary completion31 Dec 2018
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854555
Sponsor's protocol ID
980924076
Other IDs
P REK 69/2008, P REK 2009-634
Acronym
ATLET
Status last verified
Sep 2020
First submitted
1 Mar 2009
Last updated
11 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31848443

Questions about this trial

What is this clinical trial studying?

A study testing Locomotor training with robot and Locomotor training with manual assistance in people with Spinal Cord Injury, run by North Norway Rehabilitation Center at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00854555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.

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