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

NCT ID: NCT05245955

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2023-09-12

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Robotic assessment of sensory hand function

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.

Group Type: EXPERIMENTAL

Assessments of the hand sensory function with the ReHapticKnob

Intervention Type: DEVICE

During the assessment sessions with the ReHapticKnob, subjects sit comfortably on a chair in front of a screen and place the fingers of the hand on the handles of the device. The different assessments consist of moving the hand or forearm of the subjects to two different positions and asking the subject to discriminate between them (discrimination thresholds for the amplitude of grasping and forearm pronosupination positions), of passively moving the hand or forearm of the subject at low velocities and asking the subject to say when he/she detects the movement (detection thresholds for passive movements), or of rendering two objects with different stiffness and asking the subject to discriminate between them (discrimination thresholds for the stiffness of objects pinched with the hand).

Interventions

Assessments of the hand sensory function with the ReHapticKnob

During the assessment sessions with the ReHapticKnob, subjects sit comfortably on a chair in front of a screen and place the fingers of the hand on the handles of the device. The different assessments consist of moving the hand or forearm of the subjects to two different positions and asking the subject to discriminate between them (discrimination thresholds for the amplitude of grasping and forearm pronosupination positions), of passively moving the hand or forearm of the subject at low velocities and asking the subject to say when he/she detects the movement (detection thresholds for passive movements), or of rendering two objects with different stiffness and asking the subject to discriminate between them (discrimination thresholds for the stiffness of objects pinched with the hand).

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Hildebrand Brissago

OTHER

Sponsor Role: collaborator

Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana

UNKNOWN

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daria Dinacci, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clinica Hildebrand Centro di riabiliazione Brissago

Locations

Clinica Hildebrand, Centro di Rehabilitazione Brissago

Brissago, , Switzerland

Countries

Switzerland

Other Identifiers

RHK Parkinson

Identifier Type: -

Identifier Source: org_study_id