Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Box and Block Test (BBT)
研究概览
简要总结
This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups:
A - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation.
Secondary objectives include:
- Evaluating the effectiveness of an end-effector robotic system in terms of improving upper limb coordination and functionality through the ARAT test and the UPDRS.
Identifying subgroups of participants who may benefit more from robotic therapy based on PD disease stage (Hoehn & Yahr), age, and upper limb impairment.
Analyzing the effects of robotic rehabilitation on quality of life.
Assessing participants' compliance and satisfaction levels with the robotic system in terms of improving participation in upper limb rehabilitation.
详细描述
Parkinson's disease (PD) is the second most common neurodegenerative disorder, affecting over 6 million individuals worldwide, with its prevalence having increased 2.5 times in the last 30 years, making it a leading cause of neurological disability. The hallmark of PD is a motor syndrome characterized by bradykinesia, resting tremor, and rigidity, alongside postural and gait alterations. Despite being considered a movement disorder, PD often presents non-motor symptoms like hyposmia, constipation, urinary dysfunction, orthostatic hypotension, cognitive impairments, mood depression, pain, and sleep disorders. Motor symptoms progressively impair daily activities and reduce quality of life, with difficulties in gait and swallowing worsening disability over time. Specifically, upper limb motor dysfunction is marked by reduced movement speed and impaired force modulation, leading to poor hand movement quality. Motor impairment in PD is inversely correlated with movement speed and directly correlated with task complexity.
PD progresses slowly, and while current treatments manage motor symptoms effectively in the early stages, their efficacy diminishes in advanced stages, with non-motor symptoms becoming more evident. Alongside pharmacotherapy, early and regular physical rehabilitation has shown benefits, improving motor function, posture control, balance, and strength while potentially delaying disease progression. The success of PD treatment depends on treatment quality, timing, and frequency. Conventional rehabilitation includes exercise, strategy training, and patient education, focusing on enhancing upper limb coordination, fluidity, and dexterity. Although some therapies improve motor function and non-motor symptoms, limited evidence exists regarding their impact on hand dexterity.
Robotic devices, leveraging neuroplasticity and motor learning principles, have been integrated into rehabilitation to maximize sensory input and provide targeted, task-specific stimuli to the central nervous system. Advances in technology have made robotic treatments more accessible, complementing traditional physiotherapy, particularly in upper limb neurorehabilitation.
Robotic-assisted therapy (RAT) has shown efficacy in stroke rehabilitation, improving upper limb function, spasticity, and daily living activities. However, research on robotic rehabilitation for PD has primarily focused on lower limbs and gait training (RAGT), demonstrating positive effects on motor function and balance, despite limited sample sizes and follow-up studies.
Regarding upper limb rehabilitation in PD, evidence is scarce. Some studies using virtual reality systems, like Oculus Rift 2 with Leap Motion Controller (OR2-LMC), have shown improvements in strength, fine and gross dexterity, and movement speed, although discrepancies between qualitative and quantitative results were noted. Picelli et al. (2014) found that robotic-assisted upper limb training improved sensorimotor functions, but the placebo effect cannot be ruled out, emphasizing the need for larger, randomized controlled trials comparing RAT to conventional rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 80 years;
- •Diagnosis of Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria;
- •Hoehn & Yahr scale score between 2 and 3 in the "ON" phase;
- •Montreal Cognitive Assessment (MoCA) screening test with a score ≥ 17.54;
- •Stable pharmacological therapy for at least 4 weeks and throughout the treatment;
- •Ability to understand and sign the informed consent for the study;
- •Signed informed consent for the study;
- •Ability to comply with the study procedures.
排除标准
- •Unable to adhere to the exercise program due to poor compliance;
- •Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders;
- •Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility;
- •Participants who have not signed the informed consent for the study.
研究组 & 干预措施
Experimental Group (EG)
Participants assigned to Experimental Group (EG) will follow 20 sessions (3 times/week) of robotic-assisted treatment for upper limb rehabilitation using the Motore (Humanware S.r.l, Pisa, Italia ) robotic device in addition to the standard rehabilitation program.
干预措施: Experimental Group (Device)
Control Group (CG)
Participants assigned to Control Group (CG) will follow 20 sessions (3 times/week) of conventional tratment for upper limb rehabilitation in addition to the standard rehabilitation program.
干预措施: control group (Other)
结局指标
主要结局
Box and Block Test (BBT)
时间窗: Day 0 (T0 - baseline), day 50 (T1 - After treatment).
Box and Blocks test, BBT, is used to measure a manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. In Box and Blocks test there are test box with 150 blocks and a partition in the middle is placed lengthwise along the edge of a standard-height table. The test taker is instructed to quickly pick up one block at a time with his or her right or left hand. Then carry the box over the partitioned and drop it and it is important for the patient to know that each successful execution is one point and he or she carries two it will be counted as one. The number of blocks that the test taker successfully transferred will becomes the final score and the higher the score the better the gross manual dexterity of the test taker.
次要结局
- System Usability Scale (SUS)(Day 50 (T1 - After treatment).)
- Action Research Arm Test (ARAT)(Day 0 (T0 - baseline), day 50 (T1 - After treatment).)
- Unified Parkinson's Disease Rating Scale (UPDRS)(Day 0 (T0 - baseline), day 50 (T1 - After treatment).)
- Disabilities of the Arm, Shoulder and Hand (DASH)(Day 0 (T0 - baseline), day 50 (T1 - After treatment), day 140 (FU1 - 3 months after treatment Follow-Up))
- Client satisfaction questionnaire(Day 50 (T1 - After treatment).)
