- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004144
Impact of Assistive Forces on Activities of Daily Living (FLOAT-ADL)
August 25, 2025 updated by: University of Zurich
Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8008
- Universitätsklinik Balgrist
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: FLOAT-Support
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Once (single visit) around 140 minutes duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
October 24, 2019
Study Completion (Actual)
May 31, 2025
Study Registration Dates
First Submitted
September 19, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (Estimated)
December 28, 2016
Study Record Updates
Last Update Posted (Estimated)
September 2, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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