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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
排除标准
- •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
研究组 & 干预措施
Robotic assessment of sensory hand function
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.
干预措施: Assessments of the hand sensory function with the ReHapticKnob (Device)
结局指标
主要结局
Detection threshold resulting from the assessment of detection of passive grasping movements - Right hand
时间窗: 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 forearm pronosupination movements - Right forearm
时间窗: 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.
Discrimination threshold resulting from the assessment of just noticeable difference for grasping positions - Right hand
时间窗: 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 pronosupination positions - Right forearm
时间窗: 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.
Detection threshold resulting from the assessment of detection of passive grasping movements - Left hand
时间窗: 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 - Left forearm
时间窗: 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 - Left hand
时间窗: 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 haptic perception - Right hand
时间窗: 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 just noticeable difference for pronosupination positions - Left forearm
时间窗: 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 - Left hand
时间窗: 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.
次要结局
- Most affected side(This information is collected during the second examination visit (day 0 to day 0 + 2 days).)
- Demographic information(This information is collected during the screening visit performed at the beginning of the study (day 0).)
- Montreal Cognitive Assessment(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(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(This information is collected during the screening visit performed at the beginning of the study (day 0).)
- Hoehn and Yahr stage(This information is collected during the screening visit performed at the beginning of the study (day 0).)
- Edinburgh Handedness Inventory Score(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).)
- Abnormal Involuntary Movement Scale(This information is collected during the screening visit performed at the beginning of the study (day 0).)
- Levodopa equivalent daily dose(This information is collected during the second examination visit (day 0 to day 0 + 2 days).)
- MDS-Unified Parkinson's Disease Rating Scale III(This information is collected during the second examination visit (day 0 to day 0 + 2 days).)
- Frontal Assessment Battery(This assessment is performed once during the study (from day 0 to day 0 + 25 days).)
- Digit span(This assessment is performed once during the study (from day 0 to day 0 + 25 days).)
- Disease onset(This information is collected during the second examination visit (day 0 to day 0 + 2 days).)
- Attentive matrices(This assessment is performed once during the study (from day 0 to day 0 + 25 days).)
- Fatigue scale for motor and cognitive functions(This assessment is performed once during the study (from day 0 to day 0 + 25 days).)