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

Not Applicable
Completed
Conditions
Parkinson Disease
Interventions
Device: Assessments of the hand sensory function with the ReHapticKnob
Registration Number
NCT05245955
Lead Sponsor
Swiss Federal Institute of Technology
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Robotic assessment of sensory hand functionAssessments of the hand sensory function with the ReHapticKnobThis 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.
Primary Outcome Measures
NameTimeMethod
Detection threshold resulting from the assessment of detection of passive grasping movements - Right handThrough study completion, an average of 2 weeks

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 forearm pronosupination movements - Right forearmThrough study completion, an average of 2 weeks

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.

Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Right handThrough study completion, an average of 2 weeks

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 pronosupination positions - Right forearmThrough study completion, an average of 2 weeks

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.

Detection threshold resulting from the assessment of detection of passive grasping movements - Left handThrough study completion, an average of 2 weeks

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 - Left forearmThrough study completion, an average of 2 weeks

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 - Left handThrough study completion, an average of 2 weeks

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 haptic perception - Right handThrough study completion, an average of 2 weeks

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 just noticeable difference for pronosupination positions - Left forearmThrough study completion, an average of 2 weeks

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 - Left handThrough study completion, an average of 2 weeks

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
NameTimeMethod
Most affected sideThis information is collected during the second examination visit (day 0 to day 0 + 2 days).

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.

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

Gender, age, year of birth.

Montreal Cognitive AssessmentThis 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).

Assessment of cognitive function (max score = 30, high score = better).

Proprioception item of the Nottingham Sensory AssessmentThe 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).

Assessments used to characterize proprioception.

MDS-Unified Parkinson's Disease Rating Scale: items 3.15 to 3.18This information is collected during the screening visit performed at the beginning of the study (day 0).

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.

Hoehn and Yahr stageThis information is collected during the screening visit performed at the beginning of the study (day 0).

Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.

Edinburgh Handedness Inventory ScoreThis 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).

Questionnaire to define handedness.

Abnormal Involuntary Movement ScaleThis information is collected during the screening visit performed at the beginning of the study (day 0).

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 doseThis information is collected during the second examination visit (day 0 to day 0 + 2 days).

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.

MDS-Unified Parkinson's Disease Rating Scale IIIThis information is collected during the second examination visit (day 0 to day 0 + 2 days).

Scale to characterize the state of the Parkinson's disease. This is done for the group of patients with Parkinson's disease only.

Frontal Assessment BatteryThis assessment is performed once during the study (from day 0 to day 0 + 25 days).

Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.

Digit spanThis assessment is performed once during the study (from day 0 to day 0 + 25 days).

Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.

Disease onsetThis information is collected during the second examination visit (day 0 to day 0 + 2 days).

Information used to characterize the state of the Parkinson's disease. This is collected for the group of patients with Parkinson's disease only.

Attentive matricesThis assessment is performed once during the study (from day 0 to day 0 + 25 days).

Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.

Fatigue scale for motor and cognitive functionsThis assessment is performed once during the study (from day 0 to day 0 + 25 days).

Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.

Trial Locations

Locations (1)

Clinica Hildebrand, Centro di Rehabilitazione Brissago

🇨🇭

Brissago, Switzerland

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