Clinical trial NCT02993042: Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease
Official title: Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: Rehabilitation
Robot-assisted gait training
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease.

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.

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, has not been studied. Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of dual-task interference: cognitive
timeFrame: at 4 weeks
measure: Percentage of dual-task interference: physical
timeFrame: at 4 weeks
Secondary outcomes:
measure: 10 meter walk test (sec): single, cognitive dual-task, physical dual-task
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Berg balance scale
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Korean version of the Falls Efficacy Scale-International
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Step length
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Step width
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Cadence
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Vertical displacement
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Percentage of dual-task interference: cognitive
timeFrame: baseline, at 8 weeks
measure: Percentage of dual-task interference: physical
timeFrame: baseline, at 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: