Skip to main content
OpenTrials
Completed

NCT Number: NCT05245955

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Hildebrand, Centro di Rehabilitazione Brissago

Brissago, 6614, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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.

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

    Time frame: Through 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 outcomes

  1. Demographic information

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

    Gender, age, year of birth.

  2. Edinburgh Handedness Inventory Score

    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).

    Questionnaire to define handedness.

  3. Montreal Cognitive Assessment

    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).

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

  4. Proprioception item of the Nottingham Sensory Assessment

    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).

    Assessments used to characterize proprioception.

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

    Time frame: This 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.

  6. MDS-Unified Parkinson's Disease Rating Scale III

    Time frame: This 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.

  7. Hoehn and Yahr stage

    Time frame: This 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.

  8. Abnormal Involuntary Movement Scale

    Time frame: This 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.

  9. Levodopa equivalent daily dose

    Time frame: This 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.

  10. Disease onset

    Time frame: This 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.

  11. Most affected side

    Time frame: This 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.

  12. Frontal Assessment Battery

    Time frame: This 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.

  13. Attentive matrices

    Time frame: This 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.

  14. Digit span

    Time frame: This 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.

  15. Fatigue scale for motor and cognitive functions

    Time frame: This 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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Clinica Hildebrand Brissago
  • Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana

Registry information

Official study 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

Acronym: RHK Parkinson

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.