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van CCT (UK)


A robotic glove that supports ADL and therapeutic exercises


- candidate number24482
- NTR NumberNTR5897
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2016
- Secondary IDsNL56746.044.16 
- Public TitleA robotic glove that supports ADL and therapeutic exercises
- Scientific TitleThe ironHand system integrates both support in ADL and functional training exercises to improve impaired hand function
- ACRONYMironHand
- hypothesisiH system may have a beneficial effect on hand function, by directly improving functional task performance or by using it as a training tool. It may be possible that the functional use of the hand improves, allowing people to be more active in ADL and to maintain or improve their health status.
- Healt Condition(s) or Problem(s) studiedOlder adults, Stroke, Hand function
- Inclusion criteriathe elderly population must meet all of the following criteria:
- Elderly adults over the age of 55 years
- Experience difficulties in performing ADL due to a decline in hand function
- Absence of wounds on their hands that can give a problem when using the glove
- Absence of severe contractures limiting passive range of motion
- Absence of co-morbidities limiting functional use/performance of the arms/hands
- People should have at least 10 degrees of active flexion and extension of the PIP
- Sufficient cognitive status to understand two-step instructions
- Having (corrected to) normal vision
- Living at home
- Provided written informed consent

the stroke population must meet all of the following criteria:
- Patients with hand function problems who are clinically diagnosed by a physician with stroke (unilateral ischemic or hemorrhagic stroke)
- Patients over the age of 55 years
- Time since onset of disease is at least 6 months
- Discharged from specific arm/hand therapy
- Absence of severe spasticity of the hand (≤2 points on Ashworth Scale)
- Absence of wounds on their hands that can give a problem when using the glove
- Absence of severe contractures limiting passive range of motion
- Absence of co-morbidities limiting functional use/performance of the arms/hands
- People should have at least 10 degrees of active flexion and extension of the PIP
- Sufficient cognitive status to understand two-step instructions
- Having (corrected to) normal vision
- Living at home
- Provided written informed consent
- Exclusion criteriaA potential subject of either study population who meets any of the following criteria will be excluded from participation in the study in the case of:
- Severe sensory problems of the most-affected hand
- Severe acute pain of the most-affected hand
- Participation in other studies that can affect functional performance of the arm and hand
- Insufficient knowledge of the Dutch language to understand the purpose or methods of the study
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate31-mei-2017
- Target number of participants42
- InterventionsParticipants of both the elderly and patient population (via two separate randomization procedures) will be randomized into three equal groups. Group 1 will use the iH assistive system (AS) during ADL at home (iH assistive group), group 2 will use the iH therapeutic system (TS) as a training tool at home (iH therapeutic group) and group 3 will not perform any intervention at home (control group) during the intervention period of four weeks.
In the iH assistive group, participants are recommended to use the wearable robotic device for 180 minutes a week during ADL at home. The participants in the iH therapeutic group are recommended to train the hand 3 times a week for 60 minutes by performing game exercises while wearing the robotic device to support hand opening and strength and to control the game exercises on a screen. During the four weeks intervention period, all three groups will be monitored by a therapist.
- Primary outcomeJebsen-Taylor Hand Function Test
- Secondary outcomeMaximal handgrip strength (Jamar dynamometer)
Handgrip endurance
Pinch grip strength
Box and Block test
Motor activity Log (MAL)
SF-36 questionnaire
System Usability Scale (SUS) questionnaire
Intrinsic Motivation Inventory (IMI) questionnaire
Semi-structured interview about userís experience
- TimepointsBefore the intervention period and within one week after the intervention period an evaluation session will be performed.
- Trial web sitewww.ironhand.eu
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.B. Prange
- CONTACT for SCIENTIFIC QUERIESDr. G.B. Prange
- Sponsor/Initiator Roessingh Research and Development, National Foundation for the Elderly
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary Elderly people and patients with acute (e.g. stroke) or chronic (e.g. arthritis) diseases frequently experience difficulties in 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. By integrating both an assistive robotic device with exercise training, performance of ADL can be enhanced directly and/or via an improved arm and hand function after prolonged use of the hands.
The primary objective of the present study is to examine the orthotic and therapeutic effect of the ironHand (iH) system, consisting of both an assistive and therapeutic module, by elderly and diagnosed patients with hand function problems, after using the iH system for a four weeks training period at home. Secondary objectives are related to user acceptance, including usability, satisfaction, motivation and compliance.
A randomized controlled trial design will be conducted, in which both the elderly and patient population will be randomized into three groups; the iH assistive group, the iH therapeutic group and the control group. Evaluation is based on one baseline measurement and one evaluation measurement within one week after the intervention period of four weeks.
In total, twenty-seven elderly and fifteen stroke patients, with an age over 55 years, will participate in this study.
The intervention period for all three groups will last for a period of four weeks. The iH assistive group will use the wearable robotic device during ADL at home and the therapeutic iH group will use the wearable robotic device as a training tool using games via the patient user interface. Participants of the control group do not follow an intervention program. In the iH assistive group, participants are recommended to use the wearable robotic device for 180 minutes a week during ADL at home. The participants in the iH therapeutic group are recommended to train the hand 3 times a week for 60 minutes by performing game exercises while wearing the robotic device to support hand opening and strength and to control the game exercises on a screen. During the four weeks intervention period, all three groups will be monitored by a therapist.
The iH system may have a beneficial effect on hand function, by directly improving functional task performance or by using it as a training tool. It may be possible that the functional use of the hand improves, allowing people to be more active in ADL and to maintain or improve their health status. However, the exact benefit cannot be predicted, because this is the topic of the current research. The risks for the subjects are limited to a minimum. The iH 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 iH 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)
- RECORD14-jun-2016 - 8-jul-2016


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