Robot-assisted Gait Training in Patients With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Robot-assisted gait trainingDevice: Intensive treadmill training
- Registration Number
- NCT03490578
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by repeating a normal gait pattern with high intensity. This study is a randomized controlled trial to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.
- Detailed Description
Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.
Patients with Parkinson's disease are known to exhibit changes in functional connectivity of the brain from an early stage. In addition, a number of studies have reported that patients with Parkinson's disease with gait freezing have a change in resting brain activity and functional connectivity of the brain. However, no studies have examined the functional connectivity of the brain in patients with Parkinson's disease before and after rehabilitation.
Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved the recovery of independent gait after stroke compared with conventional rehabilitation therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been reported to improve walking speed and walking endurance compared to conventional physical therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has been reported that in patients with Parkinson's disease with balance impairment, robot-assisted gait training can improve balance disorder compared with physical therapy, and gait freezing has improved in some small-scale patients. However, studies on the effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and the mechanism of the effect has not been elucidated. In particular, the effect on gait automaticity, which is a characteristic of Parkinson 's disease, and functional connectivity of the brain has not been studied. Therefore, this study is aimed to investigate the effect of robot-assisted gait training on walking ability and functional connectivity of brain in patients with Parkinson's disease using an exo-skeletal robot.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Clinically confirmed patients with idiopathic Parkinson's disease
- Hoehn & Yahr stage 2.5 or 3 patients
- Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher
- Patients with severe dyskinesia or on-off fluctuations due to medication
- Patients who need to change drugs during the study period
- Patients with sensory abnormalities of the lower limb
- Patients with vestibular disease or paroxismal vertigo
- Patients with other neurological or orthopedic disease involving legs, or severe cardiovascular diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-assisted gait training Robot-assisted gait training Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P\&S Mechanics Co. Ltd., Seoul, Korea) Intensive treadmill training Intensive treadmill training Intensive treadmill training using an usual treadmill
- Primary Outcome Measures
Name Time Method 10 meter walk test (sec) : single task at 4 weeks
- Secondary Outcome Measures
Name Time Method 10 meter walk test (sec) : cognitive dual-task baseline, at 4 weeks, at 8 weeks 10 meter walk test (sec) : single task baseline, at 8 weeks Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I baseline, at 4 weeks, at 8 weeks Part I - Non-motor experiences of daily living, questionnaire
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV baseline, at 4 weeks, at 8 weeks Part IV - Motor complications, questionnaire
Berg balance scale baseline, at 4 weeks, at 8 weeks The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function (Maximum score 56).
Korean version of Falls Efficacy Scale-International baseline, at 4 weeks, at 8 weeks The FES-I is a 16-item questionnaire of fall-related self-efficacy. The 16 items of the FES-I are rated according to "how concerned you are about the possibility of falling", using the following responses (score in parentheses): not at all (1), somewhat (2), fairly (3), and very concerned (4). Thus, the total score ranges from 16 to 64 points.
10 meter walk test (sec) : physical dual-task baseline, at 4 weeks, at 8 weeks New Freezing of Gait questionnaire (NFOG-Q) - Part II, III baseline, at 4 weeks, at 8 weeks Parts II and III were designed for FRs only, providing a total summed score between 0 and 28. Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation, i.e. during turning and initiation of gait. Part III rated the impact of FOG on daily life (items 7-9, scoring range 0-9). No separate on and off rating of parts II and III was considered to avoid unreliable assessment.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III baseline, at 4 weeks, at 8 weeks Part III - Motor examination, structured physical examination
Timed-up & go test (sec) baseline, at 4 weeks, at 8 weeks New Freezing of Gait questionnaire (NFOG-Q) - Part I baseline, at 4 weeks, at 8 weeks Part I detected the presence of FOG using a dichotomous item in which individuals were classified as a freezer (FR) or a non-freezer (NFR) if they had experienced FOG-episodes during the past month.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II baseline, at 4 weeks, at 8 weeks Part II - Motor experiences of daily living, questionnaire
Functional connectivity in resting-state fMRI (Correlation coefficient) baseline, at 4 weeks * Correlation coefficient between BOLD signals in motor network
* At least 6 minutes resting state fMRI imaging is desirable for acquiring stable resting state brain imaging data. The investigators divide the entire brain into voxels, and if the investigators assume TR=3sec, one voxel has 120 time series data. This data reflects the blood-oxygenation level dependent (BOLD) signal, which is related to neural activity via a complex interplay of cerebral blood flow, blood volume, and metabolic rate of oxygen.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of