Parkinson DiseaseRHK ParkinsonNCT05245955
Robotic Assessments of Hand Function in Patients With Parkinson's Disease
A study testing Assessments of the hand sensory function with the ReHapticKnob in people with Parkinson Disease, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Assessments of the hand sensory function with the ReHapticKnob
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Mar 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinica Hildebrand, Centro di Rehabilitazione Brissago
Brissago, 6614
About this study
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
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.
Read more
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
- Being tested
- Assessments of the hand sensory function with the ReHapticKnob
- Keywords
- Parkinson Disease, Sensory impairments, Kinaesthesia, Haptic perception, Robot-assisted assessments, Assessment of the hand sensory function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments of the hand sensory function with the ReHapticKnobDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Assessments of the hand sensory function with the ReHapticKnob |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 weeks
Secondary outcomes (15)
Demographic information
Gender, age, year of birth.
Measured: This information is collected during the screening visit performed at the beginning of the study (day 0).
Edinburgh Handedness Inventory Score
Questionnaire to define handedness.
Measured: 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
Assessment of cognitive function (max score = 30, high score = better).
Measured: 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
Assessments used to characterize proprioception.
Measured: 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
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.
Measured: This information is collected during the screening visit performed at the beginning of the study (day 0).
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.
Measured: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
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.
Measured: This information is collected during the screening visit performed at the beginning of the study (day 0).
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.
Measured: This information is collected during the screening visit performed at the beginning of the study (day 0).
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.
Measured: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
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.
Measured: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
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.
Measured: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Frontal Assessment Battery
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Measured: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Attentive matrices
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Measured: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Digit span
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Measured: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Fatigue scale for motor and cognitive functions
Assessment of cognitive function. This is collected for the group of patients with Parkinson's disease only.
Measured: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start14 Mar 2022
- Primary completion11 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Hildebrand Brissago, Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana
- Responsible party
- Sponsor
- Investigators
- Daria Dinacci, Dr. med., Principal investigator, Clinica Hildebrand Centro di riabiliazione Brissago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245955
- Sponsor's protocol ID
- RHK Parkinson
- Acronym
- RHK Parkinson
- Status last verified
- Apr 2023
- First submitted
- 11 Nov 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05245955
- Acronym / sponsor ID
- RHK Parkinson / RHK Parkinson
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Sensory impairments, Kinaesthesia, Haptic perception, Robot-assisted assessments, Assessment of the hand sensory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Clinica Hildebrand Brissago, Neurocentro - Istituto di Neuroscienze Cliniche della Svizzera Italiana
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic assessment of sensory hand function | Experimental | Device: Assessments 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessments of the hand sensory function with the ReHapticKnobDuring 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). | Device | Robotic assessment of sensory hand function |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
15 secondary outcomes
Demographic information
Time frame: This information is collected during the screening visit performed at the beginning of the study (day 0).
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).
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).
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).
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).
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).
Hoehn and Yahr stage
Time frame: This information is collected during the screening visit performed at the beginning of the study (day 0).
Abnormal Involuntary Movement Scale
Time frame: This information is collected during the screening visit performed at the beginning of the study (day 0).
Levodopa equivalent daily dose
Time frame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Disease onset
Time frame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Most affected side
Time frame: This information is collected during the second examination visit (day 0 to day 0 + 2 days).
Frontal Assessment Battery
Time frame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Attentive matrices
Time frame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
Digit span
Time frame: This assessment is performed once during the study (from day 0 to day 0 + 25 days).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daria Dinacci, Dr. med. principal investigator
Clinica Hildebrand Centro di riabiliazione Brissago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessments of the hand sensory function with the ReHapticKnob in people with Parkinson Disease, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand (time frame: Through study completion, an average of 2 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.