StrokeNCT01134796
Assessment of GRASP Medical Device to Improve Arm Coordination After Stroke
An observational study of Stroke, run by University of Nottingham.
Trial summary
Assessment of a custom made grasp device in the rehabilitation of stroke victims. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Stroke pateints and healthy volunteers (controls)
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke
Assessment of a custom made grasp device in the rehabilitation of stroke victims.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulette Van Vliet, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134796
- Sponsor's protocol ID
- 09103
- Status last verified
- Dec 2015
- First submitted
- 28 May 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of GRASP II Medical Device to Improve Arm Coordination After Stroke
- ClinicalTrials.gov ID
- NCT01134796
- Acronym / sponsor ID
- 09103
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: failure to recruit
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of a custom made grasp device in the rehabilitation of stroke victims.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stroke pateints and healthy volunteers (controls)
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to grasp
Time frame: 3 sessions
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.
Results and safety
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulette Van Vliet principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to grasp (time frame: 3 sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.