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

Primary Purpose

Parkinson Disease, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot-assisted gait training
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Rehabilitation, Robot-assisted gait training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot-assisted gait training

Arm Description

Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)

Outcomes

Primary Outcome Measures

Percentage of dual-task interference: cognitive
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Percentage of dual-task interference: physical
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

Secondary Outcome Measures

10 meter walk test (sec): single, cognitive dual-task, physical dual-task
Berg balance scale
Korean version of the Falls Efficacy Scale-International
Step length
Gait analysis using IMU sensors
Step width
Gait analysis using IMU sensors
Cadence
Gait analysis using IMU sensors
Vertical displacement
Gait analysis using IMU sensors
Percentage of dual-task interference: cognitive
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Percentage of dual-task interference: physical
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test

Full Information

First Posted
December 6, 2016
Last Updated
March 8, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02993042
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic
Keywords
Rehabilitation, Robot-assisted gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted gait training
Arm Type
Experimental
Arm Description
Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)
Intervention Type
Device
Intervention Name(s)
Robot-assisted gait training
Intervention Description
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 Measure Information:
Title
Percentage of dual-task interference: cognitive
Description
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Time Frame
at 4 weeks
Title
Percentage of dual-task interference: physical
Description
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Time Frame
at 4 weeks
Secondary Outcome Measure Information:
Title
10 meter walk test (sec): single, cognitive dual-task, physical dual-task
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Berg balance scale
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Korean version of the Falls Efficacy Scale-International
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Step length
Description
Gait analysis using IMU sensors
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Step width
Description
Gait analysis using IMU sensors
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Cadence
Description
Gait analysis using IMU sensors
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Vertical displacement
Description
Gait analysis using IMU sensors
Time Frame
baseline, at 4 weeks, at 8 weeks
Title
Percentage of dual-task interference: cognitive
Description
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Time Frame
baseline, at 8 weeks
Title
Percentage of dual-task interference: physical
Description
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Time Frame
baseline, at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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

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