Study Stopped
failure to recruit
Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke
Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke
1 other identifier
observational
10
0 countries
N/A
Brief Summary
Assessment of a custom made grasp device in the rehabilitation of stroke victims.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 3, 2015
December 1, 2015
4 years
May 28, 2010
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to grasp
Primary outcome measures are: 1) The time elapsed between the start of grasp (when the finger breaks contact with the thumb) and the start of transport (when the wrist leaves the start position); and 2) The time elapsed between maximum aperture of the hand and peak deceleration of the wrist. Secondary outcome measures are: 1) movement duration, 2) time of maximum aperture expressed as % of movement duration, 3) time of peak deceleration expressed as % of movement duration, 4) amplitude of peak velocity of the wrist, 5) time of peak velocity, 6) time of peak velocity of the wrist expressed as % movement duration, 7) size of maximum aperture, 8) time to close hand from time of maximum aperture, 9) distance to target at time of maximum aperture.
3 sessions
Eligibility Criteria
Stroke pateints and healthy volunteers (controls)
You may qualify if:
- Damage to the following areas of the brain, all of which may be involved in coordination of reach to grasp confirmed by CT scan: parietal, cerebellar, internal capsule and basal ganglia,
- A score of 6 or more on the arm section of the Rivermead Motor Assessment (able to reach and pick up a tennis ball and release on thigh),
- Time between start of hand opening and start of hand transport \> 60 ms (measured with GRASP).
You may not qualify if:
- Cognitive dysfunction which prevents understanding of the task,
- Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain),
- A diagnosis of Parkinson's disease, or
- Lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulette Van Vliet
University of Nottingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 3, 2015
Record last verified: 2015-12