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NCT Number: NCT02993042

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted gait training

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2016
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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