Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke

Stroke Clinical Trial

Official title:

Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134796
• Other study ID #: 09103
• Status: Terminated
• Phase: N/A
• First received: May 28, 2010
• Last updated: December 1, 2015
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No