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Influence of assistive soft-robotic glove use on actual arm use in daily life

Influence of assistive soft-robotic glove use on actual arm use in daily life - Arm use with soft-robotic glove

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56312
Enrollment
5
Registered
2023-08-24
Start date
2024-06-03
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

neurologic disorders

Interventions

The SCED in this study will consist of three phases: a baseline phase (control condition) of varying length (randomized between min. 2 weeks and max. 4 weeks), followed by a 6-week intervention phas

Sponsors

Roessingh Centrum voor Revalidatie
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age between 16 and 90 years • Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder • Being in a chronic/stable phase of disease as judged by their physician • Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object • Ability to relax an active grip • Sufficient cognitive status to understand two-step instructions • Having (corrected to) normal vision • Able to provide written informed consent • Living independently

Exclusion criteria

Exclusion criteria: • Severe sensory problems of the most-affected hand • Severe acute pain of the most-affected hand • Wounds on the hands that can provide a problem when using the glove • Severe contractures limiting passive range of motion to the extent that the glove can*t be donned/activated comfortably • Co-morbidities limiting functional use/performance of the arms and/or hands • Severe spasticity of the hand (>=2 points on Ashworth Scale) • Severe proximal weakness (MRC shoulder elevation

Design outcomes

Primary

MeasureTime frame
The main study parameter is actual arm use as measured by two MotionWatch8 devices, containing an accelerometer, one around each wrist. In essence, the *raw* accelerometer signal will be transformed into an *activity count signal*. Actual amount of arm-hand use will then be calculated in several ways, focusing on the duration of use and the intensity of use of the affected arm-hand.

Secondary

MeasureTime frame
Maximal grip strength and survey questions about perceived hand function and overall wellbeing, in addition to glove use data, hand function, perceived amount and quality of hand use and pain, and quality of life questionnaires.

Countries

Netherlands

Contacts

Public ContactG.B. Prange

Roessingh Centrum voor Revalidatie

g.prange@rrd.nl0534875171

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026