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Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02993042
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : March 9, 2018
Sponsor:
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 feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Gait Disorders, Neurologic Device: Robot-assisted gait 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.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study
Study Start Date : December 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : February 2018

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 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.




Primary Outcome Measures :
  1. Percentage of dual-task interference: cognitive [ Time Frame: at 4 weeks ]
    (Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

  2. Percentage of dual-task interference: physical [ Time Frame: at 4 weeks ]
    (Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test


Secondary Outcome Measures :
  1. 10 meter walk test (sec): single, cognitive dual-task, physical dual-task [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  2. Berg balance scale [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  3. Korean version of the Falls Efficacy Scale-International [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
  4. Step length [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Gait analysis using IMU sensors

  5. Step width [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Gait analysis using IMU sensors

  6. Cadence [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Gait analysis using IMU sensors

  7. Vertical displacement [ Time Frame: baseline, at 4 weeks, at 8 weeks ]
    Gait analysis using IMU sensors

  8. Percentage of dual-task interference: cognitive [ Time Frame: baseline, at 8 weeks ]
    (Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

  9. Percentage of dual-task interference: physical [ Time Frame: baseline, at 8 weeks ]
    (Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test



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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): NCT02993042


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Han Gil Seo, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02993042     History of Changes
Other Study ID Numbers: RAGT-GAP
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Han Gil Seo, Seoul National University Hospital:
Rehabilitation
Robot-assisted gait training

Additional relevant MeSH terms:
Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms