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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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 19, 2016
Last Updated
September 5, 2023
Sponsor
University of Zurich
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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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