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The ironHand system integrates both support in ADL and functional training exercises to improve impaired hand function

The ironHand system integrates both support in ADL and functional training exercises to improve impaired hand function - A robotic glove that supports ADL and therapeutic exercises

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43234
Enrollment
42
Registered
2016-06-09
Start date
2016-08-02
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Handfunctie problemen bij veroudering en acute en chronische aandoeningen Ageing Elderly

Interventions

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 us

Sponsors

Revalidatiecentrum Het Roessingh
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, the 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;In order to be eligible to participate in this study, the patient population must meet all of the following criteria: *Patients with hand function problems who are clinically diagnosed by a physician with for example stroke (unilateral ischemic or hemorrhagic stroke) or rheumatoid arthritis *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) ;In order to be eligible to participate in this study, both population groups must meet all of the following criteria: *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 criteria

Exclusion criteria: A 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

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the Jebsen-Taylor Hand Function Test

Secondary

MeasureTime frame
Secundairy study parameters are outcomes related to user acceptance, changes in hand motor function, actual use and potential impact on quality of life (QoL)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)