Impact of Assistive Forces on Activities of Daily Living (FLOAT-ADL)
Primary Purpose
Spinal Cord Injury
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FLOAT
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
- informed consent as documented by signature
- bodyweight < 120 kg
Exclusion Criteria:
- a significant psychiatric or orthopedic diagnose
- any secondary neurological complications that may impact the outcome variables
- dermatological conditions (pressure ulcers, etc.)
- pacemaker or other implanted, electronic devices
- contraindications for FLOAT training
- inability or unwillingness to provide written informed consent or follow study procedures e.g. due to language problems
- psychological disorders, dementia, etc.
- known or suspected non-compliance, drug or alcohol abuse
- enrolment of the investigator, his/her family members, employees and other dependent persons
Sites / Locations
- Universitätsklinik Balgrist
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
FLOAT-Support
Arm Description
Outcomes
Primary Outcome Measures
3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks
Secondary Outcome Measures
Full Information
NCT ID
NCT03004144
First Posted
September 19, 2016
Last Updated
September 5, 2023
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03004144
Brief Title
Impact of Assistive Forces on Activities of Daily Living
Acronym
FLOAT-ADL
Official Title
Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
This study is a cross-sectional study investigating the impact of assistive forces applied by the body-weight support system "the FLOAT" on the study participants. The study is conducted at the University Hospital Balgrist in Zurich over a period of around 3 years. During this time measurements on approximately 140 able bodied subjects and 60 patients with an incomplete spinal cord injury will take place. The study participants are invited for a single visit of around 140 min duration to the University Hospital Balgrist. During this visit the study participants will repeatedly perform various activities of daily living (free walking, standing up and sitting down, stair climbing and balancing) with and without assistive forces from the body-weight support system. While performing the tasks, the study participants' motions and muscle activities will be measured to evaluate the naturalness of their movements. In addition, the collected data permits us to compare different movement patterns and make conclusions about effective and optimal movement support. Obtaining this knowledge will help us to shape the therapy of these activities to be tailored to the patients and to train these movements with the help of the FLOAT under optimal conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FLOAT-Support
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
FLOAT
Primary Outcome Measure Information:
Title
3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks
Time Frame
Once (single visit) around 140 minutes duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
informed consent as documented by signature
bodyweight < 120 kg
Exclusion Criteria:
a significant psychiatric or orthopedic diagnose
any secondary neurological complications that may impact the outcome variables
dermatological conditions (pressure ulcers, etc.)
pacemaker or other implanted, electronic devices
contraindications for FLOAT training
inability or unwillingness to provide written informed consent or follow study procedures e.g. due to language problems
psychological disorders, dementia, etc.
known or suspected non-compliance, drug or alcohol abuse
enrolment of the investigator, his/her family members, employees and other dependent persons
Facility Information:
Facility Name
Universitätsklinik Balgrist
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
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Impact of Assistive Forces on Activities of Daily Living
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