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Parkinson DiseaseNCT03490578

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

A study testing Robot-assisted gait training and Intensive treadmill training in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Robot-assisted gait training and Intensive treadmill training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
23 Apr 2018to 14 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial

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.

Read the 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.

Being tested
Robot-assisted gait training, Intensive treadmill training
Keywords
Parkinson Disease, Gait, Balance, Rehabilitation, Robot-assisted gait training
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted gait trainingDevice

    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.

  • Intensive treadmill trainingDevice

    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.

Study groups in NCT03490578
Study groupRoleWhat they receive
Robot-assisted gait trainingExperimentalRobot-assisted gait training using an exoskeletal robot (Walkbot_S; P\&S Mechanics Co. Ltd., Seoul, Korea)
Receives: Device: Robot-assisted gait training
Intensive treadmill trainingActive comparatorIntensive treadmill training using an usual treadmill
Receives: Device: Intensive treadmill training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10 meter walk test (sec) : single task

    Measured: at 4 weeks

Secondary outcomes (13)

  1. 10 meter walk test (sec) : single task

    Measured: baseline, at 8 weeks

  2. 10 meter walk test (sec) : cognitive dual-task

    Measured: baseline, at 4 weeks, at 8 weeks

  3. 10 meter walk test (sec) : physical dual-task

    Measured: baseline, at 4 weeks, at 8 weeks

  4. Berg balance scale

    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).

    Measured: baseline, at 4 weeks, at 8 weeks

  5. Timed-up & go test (sec)

    Measured: baseline, at 4 weeks, at 8 weeks

  6. Korean version of Falls Efficacy Scale-International

    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.

    Measured: baseline, at 4 weeks, at 8 weeks

  7. New Freezing of Gait questionnaire (NFOG-Q) - Part I

    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.

    Measured: baseline, at 4 weeks, at 8 weeks

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

    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.

    Measured: baseline, at 4 weeks, at 8 weeks

  9. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part I

    Part I - Non-motor experiences of daily living, questionnaire

    Measured: baseline, at 4 weeks, at 8 weeks

  10. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part II

    Part II - Motor experiences of daily living, questionnaire

    Measured: baseline, at 4 weeks, at 8 weeks

  11. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part III

    Part III - Motor examination, structured physical examination

    Measured: baseline, at 4 weeks, at 8 weeks

  12. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPRDS) - Part IV

    Part IV - Motor complications, questionnaire

    Measured: baseline, at 4 weeks, at 8 weeks

  13. Functional connectivity in resting-state fMRI (Correlation coefficient)

    • 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.

    Measured: baseline, at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study start23 Apr 2018
  3. Primary completion14 Nov 2019
  4. Study completion14 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490578
Sponsor's protocol ID
RAGT-PD1.0
Status last verified
Dec 2019
First submitted
21 Mar 2018
Last updated
4 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34896605

  • 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.

    PubMed 30616685

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted gait training and Intensive treadmill training in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10 meter walk test (sec) : single task (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490578, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.

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