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Invloed van robotische handschoen op functioneren van de arm- en handfunctie van patiënten die een beroerte door hebben gemaakt

Influence of a wearable soft robotic glove on functional ability of the arm/hand in stroke patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25281
Enrollment
10
Registered
2014-10-21
Start date
2015-01-01
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

English: stroke, CVA, arm function, hand function Nederlands: beroerte, armfunctie, handfunctie

Interventions

In the effect study, one group (experimental group 1) will use the wearable robotic device during ADL at home and the other group (experimental group 2) will use the wearable robotic device as a train

Sponsors

Roessingh Research and Development (Enschede, the Netherlands)
Lead Sponsor

Eligibility

Inclusion criteria

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 6 months • Discharged from specific arm/hand therapy • Absence of severe spasticity of the hand (≤2 points on Ashworth Scale) • Absence of severe contractures limiting passive range of motion • Absence of co-morbidities limiting functional use of the arms/hands • People should have at least 10 degrees of active flexion and extension of the fingers • Absence of wounds on their hands that can give a problem when using the glove • Sufficient cognitive status to understand two-step instructions • Having (corrected to) normal vision • Living at home • Provided written informed consent.

Exclusion criteria

Exclusion criteria: • People with severe sensory problems of the affected hand. • People with severe acute pain of the affected hand. • Participation 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.

Design outcomes

Primary

MeasureTime frame
The main study parameters are outcomes related to functional hand performance in ADL.

Secondary

MeasureTime frame
Secundary study parameters are related to user acceptance, perceived use, amount of use, changes in hand motor function and impact on quality of life.

Contacts

Public ContactG.B. Prange
g.prange@rrd.nl053-4875759

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)