NCT02098135

Brief Summary

stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,

  • Trial with medical device

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

March 6, 2014

Last Update Submit

September 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numbers of participant which can perform the ArmeoSenso - training.

    42 days

Secondary Outcomes (1)

  • Improvement in the Arm function

    42 days

Study Arms (1)

ArmeoSenso

EXPERIMENTAL

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.

Device: ArmeoSenso

Interventions

Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.

ArmeoSenso

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe aphasia
  • Severe dementia
  • Severe depression
  • Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Divison of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Andreas Luft, Prof MD

    University Hospital Zurich, Division of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 27, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

September 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations