NCT02118363

Brief Summary

Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

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

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

April 8, 2014

Last Update Submit

May 7, 2018

Conditions

Keywords

upper limblower limbmonitoringassessmentsensor

Outcome Measures

Primary Outcomes (1)

  • proof of concept

    3 month

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subakut or chronic stroke patients

You may qualify if:

  • Age: 18 or above
  • Previous Stroke in the personal history
  • Able to walk 10 meters. A walking aid (unilateral or bilateral) is permitted
  • Able to walk without special shoes
  • Able to raise the arm against gravity
  • Able to read and understand questionnaires and able to execute commands
  • Able and willing to participate in the study
  • Singed Informed Consent

You may not qualify if:

  • Contraindications on ethical grounds (vulnerable persons)
  • known or suspected non-compliance, drug or alcohol abuse,
  • Severe aphasia
  • Severe dementia
  • Severe depression
  • Relevant medical disease or increased risk of rehospitalization
  • Severe sensory deficits
  • Severe neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cereneo

Vitznau, 6354, Switzerland

Location

Related Publications (1)

  • Held JPO, Klaassen B, Eenhoorn A, van Beijnum BF, Buurke JH, Veltink PH, Luft AR. Inertial Sensor Measurements of Upper-Limb Kinematics in Stroke Patients in Clinic and Home Environment. Front Bioeng Biotechnol. 2018 Apr 12;6:27. doi: 10.3389/fbioe.2018.00027. eCollection 2018.

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations