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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014