Clinical trial NCT03490578: Robot-assisted Gait Training in Patients With Parkinson's Disease
Official title: Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Gait
Balance
Rehabilitation
Robot-assisted gait training
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Rehabilitation Center, Seoul, Korea
First posted: 2018-04-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
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 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.

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: 10 meter walk test (sec) : single task
timeFrame: at 4 weeks
Secondary outcomes:
measure: 10 meter walk test (sec) : single task
timeFrame: baseline, at 8 weeks
measure: 10 meter walk test (sec) : cognitive dual-task
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: 10 meter walk test (sec) : physical dual-task
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Berg balance scale
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Timed-up & go test (sec)
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Korean version of Falls Efficacy Scale-International
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: New Freezing of Gait questionnaire (NFOG-Q) - Part I
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: New Freezing of Gait questionnaire (NFOG-Q) - Part II, III
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV
timeFrame: baseline, at 4 weeks, at 8 weeks
measure: Functional connectivity in resting-state fMRI (Correlation coefficient)
timeFrame: baseline, at 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han Gil Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim H, Kim E, Yun SJ, Kang MG, Shin HI, Oh BM, Seo HG. Robot-assisted gait training with auditory and visual cues in Parkinson's disease: A randomized controlled trial. Ann Phys Rehabil Med. 2022 May;65(3):101620. doi: 10.1016/j.rehab.2021.101620. Epub 2022 Feb 23.
citation: Kang MG, Yun SJ, Shin HI, Kim E, Lee HH, Oh BM, Seo HG. Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 7;20(1):15. doi: 10.1186/s13063-018-3123-4.