Clinical trial NCT05245955: Robotic Assessments of Hand Function in Patients With Parkinson's Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Sensory impairments
Kinaesthesia
Haptic perception
Robot-assisted assessments
Assessment of the hand sensory function
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Clinica Hildebrand Brissago
name: Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana
First posted: 2022-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand
timeFrame: Through study completion, an average of 2 weeks
measure: Detection threshold resulting from the assessment of detection of passive grasping movements - Left hand
timeFrame: Through study completion, an average of 2 weeks
measure: Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Right forearm
timeFrame: Through study completion, an average of 2 weeks
measure: Detection threshold resulting from the assessment of detection of passive forearm pronosupination movements - Left forearm
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Right hand
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Left hand
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Right forearm
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of just noticeable difference for pronosupination positions - Left forearm
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of haptic perception - Right hand
timeFrame: Through study completion, an average of 2 weeks
measure: Discrimination threshold resulting from the assessment of haptic perception - Left hand
timeFrame: Through study completion, an average of 2 weeks
Secondary outcomes:
measure: Demographic information
timeFrame: This information is collected during the screening visit performed at the beginning of the study (day 0).
measure: Edinburgh Handedness Inventory Score
timeFrame: 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).
measure: Montreal Cognitive Assessment
timeFrame: 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).
measure: Proprioception item of the Nottingham Sensory Assessment
timeFrame: 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).
measure: MDS-Unified Parkinson's Disease Rating Scale: items 3.15 to 3.18
timeFrame: This information is collected during the screening visit performed at the beginning of the study (day 0).
measure: MDS-Unified Parkinson's Disease Rating Scale III
timeFrame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
measure: Hoehn and Yahr stage
timeFrame: This information is collected during the screening visit performed at the beginning of the study (day 0).
measure: Abnormal Involuntary Movement Scale
timeFrame: This information is collected during the screening visit performed at the beginning of the study (day 0).
measure: Levodopa equivalent daily dose
timeFrame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
measure: Disease onset
timeFrame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
measure: Most affected side
timeFrame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
measure: Frontal Assessment Battery
timeFrame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
measure: Attentive matrices
timeFrame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
measure: Digit span
timeFrame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
measure: Fatigue scale for motor and cognitive functions
timeFrame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Other outcomes:
Locations:
city: Brissago
country: Switzerland
facility: Clinica Hildebrand, Centro di Rehabilitazione Brissago
Study officials:
affiliation: Clinica Hildebrand Centro di riabiliazione Brissago
name: Daria Dinacci, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: