Back to resultsArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
Primary Purpose
Stroke, Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ArmeoSenso
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion criteria:
- 18 years old
- Stroke or spinal cord injury in prehistory
- Motor deficits of the upper limb (s)
- Lifting the paretic arm against gravity possible AND
- Minimum amount of movement in the horizontal plane of 20 x 20 cm
- Ability and willingness to participate in the study
Exclusion criteria:
- Severe aphasia
- Severe dementia
- Severe depression
- Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
Sites / Locations
- University Hospital Zurich, Divison of Neurology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ArmeoSenso
Arm Description
The ArmeoSenso system is an easy to set up and use upper limb rehabilitation system for the home environment. It consists of a motion capture system based on wearable sensors in combination with a personal computer as well as a therapy software that provides an ergonomic user interface, therapy games and automated assessments.
Outcomes
Primary Outcome Measures
Numbers of participant which can perform the ArmeoSenso - training.
Secondary Outcome Measures
Improvement in the Arm function
WMFT (Wolf Motor Function Test), FMA-UL (Fugl-Meyer Assessment - Upper Limb), GRASSP (Graded and Redefined Assessment of Strength, Sensibility and Prehension)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02098135
Brief Title
ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
Official Title
Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,
Trial with medical device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ArmeoSenso
Arm Type
Experimental
Arm Description
The ArmeoSenso system is an easy to set up and use upper limb rehabilitation system for the home environment. It consists of a motion capture system based on wearable sensors in combination with a personal computer as well as a therapy software that provides an ergonomic user interface, therapy games and automated assessments.
Intervention Type
Device
Intervention Name(s)
ArmeoSenso
Intervention Description
Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.
Primary Outcome Measure Information:
Title
Numbers of participant which can perform the ArmeoSenso - training.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Improvement in the Arm function
Description
WMFT (Wolf Motor Function Test), FMA-UL (Fugl-Meyer Assessment - Upper Limb), GRASSP (Graded and Redefined Assessment of Strength, Sensibility and Prehension)
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18 years old
Stroke or spinal cord injury in prehistory
Motor deficits of the upper limb (s)
Lifting the paretic arm against gravity possible AND
Minimum amount of movement in the horizontal plane of 20 x 20 cm
Ability and willingness to participate in the study
Exclusion criteria:
Severe aphasia
Severe dementia
Severe depression
Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Luft, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Divison of Neurology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27515583
Citation
Wittmann F, Held JP, Lambercy O, Starkey ML, Curt A, Hover R, Gassert R, Luft AR, Gonzenbach RR. Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system. J Neuroeng Rehabil. 2016 Aug 11;13(1):75. doi: 10.1186/s12984-016-0182-1.
Results Reference
derived
Learn more about this trial
ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
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