Body Weight Supported Training Study
Primary Purpose
Spinal Cord Diseases
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
BWS overground training
BWS treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Diseases
Eligibility 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 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
Sites / Locations
- University of Zurich, Balgrist University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SCI-patients receiving overground training
SCI-patients receiving treadmill training
Arm Description
Outcomes
Primary Outcome Measures
Timed Up and Go (TUG)
Secondary Outcome Measures
Full Information
NCT ID
NCT03534518
First Posted
May 7, 2018
Last Updated
September 5, 2023
Sponsor
University of Zurich
Collaborators
Foundation Wings For Life
1. Study Identification
Unique Protocol Identification Number
NCT03534518
Brief Title
Body Weight Supported Training Study
Official Title
Body Weight Supported Overground Gait Training to Promote Recovery of Walking Function in Chronic Spinal Cord Injury: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Foundation Wings For Life
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCI-patients receiving overground training
Arm Type
Active Comparator
Arm Title
SCI-patients receiving treadmill training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
BWS overground training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BWS treadmill training
Intervention Description
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 Measure Information:
Title
Timed Up and Go (TUG)
Time Frame
Change from day 0 at day 28 and at day 56-63 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
University of Zurich, Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
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Body Weight Supported Training Study
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