NCT01134796

Brief Summary

Assessment of a custom made grasp device in the rehabilitation of stroke victims.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Status
terminated

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

May 28, 2010

Last Update Submit

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

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paulette Van Vliet

    University of Nottingham

    PRINCIPAL INVESTIGATOR

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