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Robot-assisted Gait Training in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490578
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
National Rehabilitation Center, Seoul, Korea
Information provided by (Responsible Party):
Han Gil Seo, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Robot-assisted gait training Device: Intensive treadmill training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : November 14, 2019
Actual Study Completion Date : November 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-assisted gait training
Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)
Device: Robot-assisted gait training
Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.0 km/h and can be increased gradually to 3.0 km/h. The gait robot provides an auditory feedback according to gait cycle and a visual feedback on the patient's active participation. If the patient can tolerate, the gait robot may control the walking speed automatically according to the patient's participation. The treatment time per session is 45 minutes including don and doff time. Total 12 sessions are provided for 4 weeks.

Active Comparator: Intensive treadmill training
Intensive treadmill training using an usual treadmill
Device: Intensive treadmill training
Patients exercise on the treadmill. The initial walking speed starts at 1.0 km/h and can be increased gradually to 3.0 km/h. The therapist provides appropriate visual and auditory instructions to allow the patient to participate in the treadmill training. The treatment time per session is 45 minutes including warm-up and cool-down. Total 12 sessions are provided for 4 weeks.




Primary Outcome Measures :
  1. 10 meter walk test (sec) : single task [ Time Frame: at 4 weeks ]

Secondary Outcome Measures :
  1. 10 meter walk test (sec) : single task [ Time Frame: baseline, at 8 weeks ]
  2. 10 meter walk test (sec) : cognitive dual-task [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  3. 10 meter walk test (sec) : physical dual-task [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  4. Berg balance scale [ Time Frame: 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).

  5. Timed-up & go test (sec) [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  6. Korean version of Falls Efficacy Scale-International [ Time Frame: 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.

  7. New Freezing of Gait questionnaire (NFOG-Q) - Part I [ Time Frame: 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.

  8. New Freezing of Gait questionnaire (NFOG-Q) - Part II, III [ Time Frame: 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.

  9. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Part I - Non-motor experiences of daily living, questionnaire

  10. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Part II - Motor experiences of daily living, questionnaire

  11. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Part III - Motor examination, structured physical examination

  12. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Part IV - Motor complications, questionnaire

  13. Functional connectivity in resting-state fMRI (Correlation coefficient) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490578


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
National Rehabilitation Center, Seoul, Korea
Investigators
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Principal Investigator: Han Gil Seo, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Han Gil Seo, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03490578    
Other Study ID Numbers: RAGT-PD1.0
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Gil Seo, Seoul National University Hospital:
Parkinson Disease
Gait
Balance
Rehabilitation
Robot-assisted gait training
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases