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Body Weight Supported Training Study

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ClinicalTrials.gov Identifier: NCT03534518
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Foundation Wings For Life
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Successful ambulation at home and in the community is the main goal of gait training after incomplete spinal cord injury. Many different treatment approaches have been recommended to achieve this goal. One established intervention to achieve that in a clinical setting is body weight supported (BWS) treadmill training. However, recent studies have suggested that the most optimal gait training should be conducted overground with appropriate support conditions to enable a physiological gait pattern. The training has to be challenging and patients must participate as active as possible.

In addition becoming a functional walker in real world involves a variety of walking skills like walking on uneven surfaces, walking up and down slopes, climbing stairs and avoid obstacles. It has been shown in humans as well as in animals that greater improvements are achieved in walking function if the training is task specific. Thus a constrained task like BWS treadmill training may not be the optimal training intervention to become a functional community walker.

Even greater improvements can be expected if patients feel safe during the overground walking and train at their individual limits. With FLOAT there is now the possibility to conduct a task specific BWS overground gait training in a safe environment. The robotic device allows patients to perform different walking tasks like walking overground, avoiding obstacles, walking on uneven and sloped surfaces, climbing stairs, walking in narrow spaces. A virtual reality setup was integrated into the system that even can simulate specific walking tasks like target oriented walking or walking in crowded environment. Based on the promising results seen in preclinical and clinical research, the investigators assume that unrestricted transparent BWS overground training that allows task specific training of real world walking tasks will induce greater improvements than conventional BWS treadmill training.

The investigators will compare the effect of an intensive 4 weeks unrestricted BWS overground gait training to 4 weeks of intensive BWS treadmill training. Not only functional outcome like walking speed or capacity will be assessed but also detailed kinematics that will help to identify the mechanisms of the underlying improvements in walking function.


Condition or disease Intervention/treatment Phase
Spinal Cord Diseases Other: BWS overground training Other: BWS treadmill training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Weight Supported Overground Gait Training to Promote Recovery of Walking Function in Chronic Spinal Cord Injury: a Randomized Clinical Trial
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SCI-patients receiving overground training Other: BWS overground training
BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. The walking tasks will be roughly divided into different domains like skilled walking, balance, dual tasking, walking speed, walking endurance.

Active Comparator: SCI-patients receiving treadmill training Other: BWS treadmill training
Training will be conducted on a standard treadmill with an overhead BWS system that can provide active BWS. Participants are allowed to hold the rails but weight bearing is not allowed. BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. Main walking tasks will be endurance (walking long distances at preferred speed) and speed (walking at maximal possible speed).




Primary Outcome Measures :
  1. Change of walking ability (6mWT) [ Time Frame: Prior, in the middle, at the end of and 1 month after the training intervention ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • Chronic spinal cord injury (>6 months)
  • Incomplete traumatic or non-traumatic lesion (AIS C, D) above T12
  • Able to walk 10m with or without walking devices or physical assistance
  • Mini-Mental state examination score ³26 (test will only be performed if cognitive deficits are suspected)

Exclusion Criteria:

  • Walking speed > 1.1m/s in 10mWT
  • Walking capacity > 500m in 6mWT
  • Current orthopaedic problems
  • History of cardiac condition
  • Epilepsy
  • Potential pregnancy (pregnancy test must be conducted before
  • Each neurophysiological testing)Pressure sore stage 2 or higher, located where a harness could affect healing
  • Premorbid major depression or psychosis
  • Unlikely to complete the intervention or return for follow-up
  • Participation in another training study
  • Body weight > 120kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534518


Contacts
Contact: Romina Willi, MSc +41 510 72 91 romina.willi@balgrist.ch
Contact: Marc Bolliger, PD Dr. +41 510 72 01 marc.bolliger@balgrist.ch

Locations
Switzerland
University of Zurich, Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
University of Zurich
Foundation Wings For Life

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03534518     History of Changes
Other Study ID Numbers: 2018-00811
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Body Weight
Spinal Cord Diseases
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases