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

NCT05245955 | Completed

• 1 other identifier: RHK Parkinson
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson Disease; Sensory impairments; Kinaesthesia; Haptic perception; Robot-assisted assessments; Assessment of the hand sensory function

Outcome Measures

Primary Outcomes (10)

• Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand

  Outcome of the assessment for the detection of passive grasping movements performed with the right hand. This threshold is expressed in time until movement detection.

  Through study completion, an average of 2 weeks

• Detection threshold resulting from the assessment of detection of passive grasping movements - Left hand

  Outcome of the assessment for the detection of passive grasping movements performed with the left hand. This threshold is expressed in time until movement detection.

  Through study completion, an average of 2 weeks

• Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Right forearm

  Outcome of the assessment for the detection of passive forearm pronosupination movements performed with the right forearm. This threshold is expressed in time until movement detection.

  Through study completion, an average of 2 weeks

• Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Left forearm

  Outcome of the assessment for the detection of passive forearm pronosupination movements performed with the left forearm. This threshold is expressed in time until movement detection.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Right hand

  Outcome of the assessment for the discrimination of grasping positions performed with the right hand. This threshold is expressed in millimeters and represents the minimum difference that the subject can perceive.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Left hand

  Outcome of the assessment for the discrimination of grasping positions performed with the left hand. This threshold is expressed in millimeters and represents the minimum difference that the subject can perceive.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Right forearm

  Outcome of the assessment for the discrimination of pronosupination positions performed with the right forearm. This threshold is expressed in degrees and represents the minimum difference that the subject can perceive.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Left forearm

  Outcome of the assessment for the discrimination of pronosupination positions performed with the left forearm. This threshold is expressed in degrees and represents the minimum difference that the subject can perceive.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of haptic perception - Right hand

  Outcome of the assessment for haptic perception performed with the right hand. This threshold is expressed as Weber Fraction and represents the minimum difference in stiffness that the subject can perceive.

  Through study completion, an average of 2 weeks

• Discrimination threshold resulting from the assessment of haptic perception - Left hand

  Outcome of the assessment for haptic perception performed with the left hand. This threshold is expressed as Weber Fraction and represents the minimum difference in stiffness that the subject can perceive.

  Through study completion, an average of 2 weeks

Secondary Outcomes (15)

• Demographic information

  This information is collected during the screening visit performed at the beginning of the study (day 0).

• Edinburgh Handedness Inventory Score

  This information is collected during the screening visit performed at the beginning of the study (day 0).This information is collected during the screening visit performed at the beginning of the study (day 0).

• Montreal Cognitive Assessment

  This information is collected during the screening visit performed at the beginning of the study (day 0).This information is collected during the screening visit performed at the beginning of the study (day 0).

• Proprioception item of the Nottingham Sensory Assessment

  The control group does this assessment during the screening visit (day 0). The group of patients with Parkinson's disease does this during the second examination visit (day 0 to day 0 + 2 days).

• MDS-Unified Parkinson's Disease Rating Scale: items 3.15 to 3.18

  This information is collected during the screening visit performed at the beginning of the study (day 0).

Study Arms (1)

Robotic assessment of sensory hand function

EXPERIMENTAL

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.

Device: Assessments of the hand sensory function with the ReHapticKnob

Interventions

Assessments of the hand sensory function with the ReHapticKnob 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).

Robotic assessment of sensory hand function

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Clinica Hildebrand Brissago: collaborator
• Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana: collaborator

Study Sites (1)

Clinica Hildebrand, Centro di Rehabilitazione Brissago

Brissago, 6614, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Daria Dinacci, Dr. med.

  Clinica Hildebrand Centro di riabiliazione Brissago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: February 18, 2022
• Study Start: March 14, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 12, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)