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Robotic Assessments of Hand Function in Patients With Parkinson's Disease (RHK Parkinson)

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: Assessments of the hand sensory function with the ReHapticKnob

Study type

Interventional

Funder types

Other

Identifiers

NCT05245955
RHK Parkinson

Details and patient eligibility

About

It has been shown that patients with Parkinson's disease (PD) have impaired kinaesthesia and haptic perception of the upper limbs. In PD patients, these impairments might be involved in the development of hypometria or bradykinesia and may play a role in postural deficits, thereby significantly contributing to the overall disability level.

Dedicated conventional or robot-assisted training might improve sensory-motor function in PD patients. In order to provide efficient robot-assisted therapy, robotic devices have to be able to tailor the therapy difficulty to the individual impairment profile of each patient. For difficulty adaptation in robot-assisted therapy, it is important to assess the impairment profiles with the same robotic platform that would be used for therapy, therefore minimizing costs or potential errors coming from the use of different devices. However, up to now, little emphasis has been placed on providing sensory-motor robot-assisted therapy for the upper limbs to persons with PD based on their individual level of impairment.

The aim of this study is therefore to evaluate if the assessments of sensory-motor hand function implemented on a robotic device for hand rehabilitation, i.e. the ReHapticKnob, are suitable to measure the impairments of kinaesthesia and haptic perception observed in subjects with Parkinson's disease.

If the assessments implemented in the ReHapticKnob are sensitive enough to detect a difference between the sensory-motor function of PD patients and healthy subjects, the device might in the future be used to assess improvements before and after sensory-motor therapy. This is a necessary step before the investigators can use these assessments to tailor the difficulty level of the therapy performed with the ReHapticKnob and to investigate the benefits and impact of such a therapy on the kinaesthetic and haptic impairments of persons with PD.

Enrollment

20 patients

Sex

All

Ages

35 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Ten patients with Parkinson's disease and 10 age-matched control subjects will be recruited.

Patients with Parkinson's disease: inclusion criteria

  • Diagnosis of idiopathic Parkinson's disease according to UK Parkinson's disease society brain bank clinical diagnostic criteria

  • Age between 35 and 80 years

  • Hoehn and Yahr stage of I, II or III during the ON state

  • Montreal Cognitive Assessment (MoCA) ≥ 26

  • No tremor, i.e.:

    • Postural tremor for the hand: MDS-UPDRS 3.15 < 1
    • Kinetic tremor of the hands: MDS-UPDRS 3.16 ≤ 1
    • Rest tremor amplitude for the extremities: MDS-UPDRS 3.17 < 1
    • Constancy of rest tremor: MDS-UPDRS 3.18 < 1
  • The subject read, understood and signed the informed consent

Patients with Parkinson's disease: exclusion criteria

  • Polyneuropathy registered in the anamnesis or peripheral sensory-motor impairments detected in a neurological clinical examination
  • Mild to severe dyskinesia of the upper limbs: point 5 of the Abnormal Involuntary Movement Scale (AIMS) > 1
  • Orthopedic pathologies of the upper limbs or other pathologies possibly interfering with the study
  • Pacemaker, deep-brain-stimulator or other active implanted devices

Control subjects: inclusion criteria

  • Age between 35 and 80 years
  • Montreal Cognitive Assessment (MoCA) ≥ 26
  • The subject read, understood and signed the informed consent

Control subjects: exclusion criteria

  • Any history of neurological, orthopaedic or rheumatologic disease affecting the upper limbs or other pathologies possibly interfering with the study
  • Pacemaker or other active implanted devices

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Robotic assessment of sensory hand function
Experimental group
Description:
This arm involves a group of persons with Parkinson's disease and an age-matched control group. Both groups undergo the assessments of kinaesthesia and haptic perception of the hand implemented on the ReHapticKnob.
Treatment:
Device: Assessments of the hand sensory function with the ReHapticKnob

Trial contacts and locations

1

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Central trial contact

Giada Devittori, M. Sc.; Olivier Lambercy, Dr.

Data sourced from clinicaltrials.gov

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