ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors

Stroke Clinical Trial

Official title:

Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098135
• Other study ID #: 2013-0182
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: September 14, 2015
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

• Trial with medical device

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

Device:
• ArmeoSenso
Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Divison of Neurology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of participant which can perform the ArmeoSenso - training.		42 days	Yes
Secondary	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)	42 days	No