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Invloed van een robotische handschoen op het reiken en grijpen na CVA


- candidate number25340
- NTR NumberNTR6097
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2016
- Secondary IDsNL58778.044.16, P16-17 ToetsingOnline, METC
- Public TitleInvloed van een robotische handschoen op het reiken en grijpen na CVA
- Scientific TitleInfluence of a robotic glove on movement execution of stroke patients during reaching and grasping
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedStroke, Upper extremity, Function
- Inclusion 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
- Sufficient cognitive status to understand two-step instructions - Having (corrected to) normal vision
-Provided written informed consent
- Exclusion criteria- People with severe sensory problems of the affected upper extremity
- People with severe acute pain of the affected arm -People who participate in other studies that can affect functional performance of the arm and 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 receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate
- Target number of participants10
- Interventions-
- Primary outcomeThe main study parameters are outcomes related to (functional) task performance and movement execution. To examine the direct influence of the grasp support system on (functional) performance of the most-affected arm and hand during the different proposed conditions, the following main study parameters will be measured: • Qualitative observations of functional task performance and movement execution (e.g. speed of movement, precision, fluidity, compensatory movements) • Quantitative parameters of functional task performance and movement execution (e.g. performance time, kinematics of hand and arm joints, movement path, velocity (profile), acceleration and jerk)
- Secondary outcomeTo explore user acceptance of the grasp support system and to examine the direct effect of the grasp support system on changes in hand strength and movement execution, the following parameters will be registered during the measurements: • System Usability Scale (SUS) • Semi-structured interview about user’s experience • Action Research Arm Test (ARAT) • Maximal pinch force (Jamar pinch Gauge dynamometer)
- TimepointsPatients will visit the lab once.
Movement execution will be researched and analyzed with a 3D motion analysis system (VICON) and afterwards with a custom written matlab file.
User acceptance will be measured with the System Usability scale and semi-structured interviews
Hand strength will be measured with a dynanometer
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.L. van Ommeren
- CONTACT for SCIENTIFIC QUERIES A.L. van Ommeren
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
H2020, grant agreement number 644000
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD29-sep-2016 - 11-nov-2016


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