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van CCT (UK)

van CCT (UK)

Influence of a robotic glove on reaching and grasping in stroke

- candidate number25486
- NTR NumberNTR6196
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-okt-2016
- Secondary IDsNL58778.044.16 
- Public TitleInfluence of a robotic glove on reaching and grasping in stroke
- Scientific TitleInfluence of a robotic glove on movement execution of stroke patients during reaching and grasping
- hypothesis
- Healt Condition(s) or Problem(s) studiedStroke, Cerebral bleeding, Robotics, Activities of Daily Life (ADL)
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all the following criteria:
 Patients should be clinically diagnosed with unilateral ischemic or hemorrhagic stroke
 Between 18-80 years of age
 Time since onset of disease is at least three months
 At least 10 degrees of active flexion and extension of the fingers
 Absence of wounds on their arm that can give a problem when using the system
 Sufficient cognitive status to understand two-step instructions
 Having (corrected to) normal vision
 Provided written informed consent
- Exclusion criteriaA potential stroke patient who meets any of the following criteria will be excluded from participation:
 People with severe sensory problems of the affected upper extremity
 People with severe acute pain of the affected hand
 People who participate in other studies that can affect functional performance of the hand
 People having insufficient knowledge of the Dutch language to understand the purpose or methods of the study
 People with severe contractures limiting passive range of motion
 People with co-morbidities limiting functional use of the hand
 People with wounds on their hand that can give a problem when using the system
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate1-nov-2018
- Target number of participants10
- InterventionsParticipants will be asked to perform reaching and grasping with and without wearing a robotic glove. Performance with and without support will be compared
- Primary outcomeMain study parameters are outcomes related to (functional) task performance
- Secondary outcomeSystem usability outcomes (SUS) and semi-structured interview Hand strength ( JAmar pinch Gauge dynanometer)
Arm Research Arm Test (ARAT)
- TimepointsParticipants will visit the lab once
- Trial web site-
- statusplanned
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
European Union H2020
- Publications
- Brief summaryStroke survivors frequently experience difficulties with performing activities of daily living (ADL) due to a decline in hand function. They often need personal and/or assistive devices to carry out ADL. However, personal assistance will not result in more independence in performing ADL while assistive devices have the potential to provide the assistance that is necessary to perform ADL independently. New technological innovations can support the functional performance of the arms and hands directly by a wearable soft robotic device assisting a personís own function. If people can maintain or increase use of their hands/arms in daily life, this might ultimately even benefit their (unsupported) arm function in ADL. The primary objective of this study is to examine the direct influence of the grasp support system on (functional) performance of the most-affected arm and hand In total, 10 participants diagnosed with post-stroke hemiparesis with an age over 18 will participate in this study. Patients will be recruited in the Netherlands. Stroke survivors will perform several hand function tasks and clinical tasks with and without the wearable robotic device to assess the direct influence of the device on functional task performance, ability to perform functional tasks and user acceptance. The main study parameters are outcomes related to (functional) task performance.The risks for the subjects are limited to a minimum. The grasp support system is a device that facilitates hand grip and opening as initiated by the user him/herself. It provides support only when necessary based on voluntary, active initiation by the person him/herself. Furthermore, the grasp support system is a so-called soft-robotics device, constructed from soft materials that are comfortable to wear and compliant with human movement. This prevents potential occurrence of pressure points for example. All movements conducted during the study will consist of arm/hand movements that normally occur in ADL and within the abilities of each individual. Additionally, all the evaluation measurements used in these studies are non-invasive and involve no risks for the subjects.
- Main changes (audit trail)
- RECORD31-okt-2016 - 19-feb-2017

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