Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01134796
First received: May 28, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Time to grasp [ Time Frame: 3 sessions ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Stroke pateints and healthy volunteers (controls)

Criteria

Inclusion Criteria:

  1. 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,
  2. 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),
  3. Time between start of hand opening and start of hand transport > 60 ms (measured with GRASP).

Exclusion Criteria:

  1. Cognitive dysfunction which prevents understanding of the task,
  2. Severe concurrent medical problems that prevent repetitive reaching (including shoulder pain),
  3. A diagnosis of Parkinson's disease, or
  4. Lack of informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134796

Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Paulette Van Vliet University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01134796     History of Changes
Other Study ID Numbers: 09103
Study First Received: May 28, 2010
Last Updated: January 14, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014