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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Assessments of the hand sensory function with the ReHapticKnob
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson Disease, Sensory impairments, Kinaesthesia, Haptic perception, Robot-assisted assessments, Assessment of the hand sensory function

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Hildebrand, Centro di Rehabilitazione Brissago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic assessment of sensory hand function

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Demographic information
Gender, age, year of birth.
Edinburgh Handedness Inventory Score
Questionnaire to define handedness.
Montreal Cognitive Assessment
Assessment of cognitive function (max score = 30, high score = better).
Proprioception item of the Nottingham Sensory Assessment
Assessments used to characterize proprioception.
MDS-Unified Parkinson's Disease Rating Scale: items 3.15 to 3.18
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only. These items are performed at the beginning as they are considered for the inclusion criteria.
MDS-Unified Parkinson's Disease Rating Scale III
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Hoehn and Yahr stage
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Abnormal Involuntary Movement Scale
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Levodopa equivalent daily dose
Information used to characterize the state of the Parkinson's disease and the timespan when the patient is in the ON state. This is collected for the group of patients with Parkinson's disease only.
Disease onset
Information used to characterize the state of the Parkinson's disease. This is collected for the group of patients with Parkinson's disease only.
Most affected side
Information used to characterize the side of the body most affected by the Parkinson's disease. This is collected for the group of patients with Parkinson's disease only.
Frontal Assessment Battery
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Attentive matrices
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Digit span
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Fatigue scale for motor and cognitive functions
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.

Full Information

First Posted
November 11, 2021
Last Updated
September 12, 2023
Sponsor
Swiss Federal Institute of Technology
Collaborators
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana
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1. Study Identification

Unique Protocol Identification Number
NCT05245955
Brief Title
Robotic Assessments of Hand Function in Patients With Parkinson's Disease
Acronym
RHK Parkinson
Official Title
Feasibility and Validity of Robotic Assessments With the ReHapticKnob to Characterize Kinaesthesia and Haptic Perception of the Hand in Patients With Parkinson's Disease: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
September 11, 2023 (Actual)
Study Completion Date
September 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO, Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Sensory impairments, Kinaesthesia, Haptic perception, Robot-assisted assessments, Assessment of the hand sensory function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic assessment of sensory hand function
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Assessments of the hand sensory function with the ReHapticKnob
Intervention Description
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).
Primary Outcome Measure Information:
Title
Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Detection threshold resulting from the assessment of detection of passive grasping movements - Left hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Right forearm
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Left forearm
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Right hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Left hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Right forearm
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Left forearm
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of haptic perception - Right hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Title
Discrimination threshold resulting from the assessment of haptic perception - Left hand
Description
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.
Time Frame
Through study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Demographic information
Description
Gender, age, year of birth.
Time Frame
This information is collected during the screening visit performed at the beginning of the study (day 0).
Title
Edinburgh Handedness Inventory Score
Description
Questionnaire to define handedness.
Time Frame
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).
Title
Montreal Cognitive Assessment
Description
Assessment of cognitive function (max score = 30, high score = better).
Time Frame
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).
Title
Proprioception item of the Nottingham Sensory Assessment
Description
Assessments used to characterize proprioception.
Time Frame
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).
Title
MDS-Unified Parkinson's Disease Rating Scale: items 3.15 to 3.18
Description
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only. These items are performed at the beginning as they are considered for the inclusion criteria.
Time Frame
This information is collected during the screening visit performed at the beginning of the study (day 0).
Title
MDS-Unified Parkinson's Disease Rating Scale III
Description
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Title
Hoehn and Yahr stage
Description
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the screening visit performed at the beginning of the study (day 0).
Title
Abnormal Involuntary Movement Scale
Description
Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the screening visit performed at the beginning of the study (day 0).
Title
Levodopa equivalent daily dose
Description
Information used to characterize the state of the Parkinson's disease and the timespan when the patient is in the ON state. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Title
Disease onset
Description
Information used to characterize the state of the Parkinson's disease. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Title
Most affected side
Description
Information used to characterize the side of the body most affected by the Parkinson's disease. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Title
Frontal Assessment Battery
Description
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Title
Attentive matrices
Description
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Title
Digit span
Description
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Title
Fatigue scale for motor and cognitive functions
Description
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Time Frame
This assessment is performed once during the study (from day 0 to day 0 + 25 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daria Dinacci, Dr. med.
Organizational Affiliation
Clinica Hildebrand Centro di riabiliazione Brissago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Hildebrand, Centro di Rehabilitazione Brissago
City
Brissago
ZIP/Postal Code
6614
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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