Parkinson DiseaseNCT02993042
Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease
A study testing Robot-assisted gait training in people with Parkinson Disease and Gait Disorders, Neurologic, run by Seoul National University Hospital at 1 site in South Korea.
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 feasibility study to investigate whether robot-assisted gait training can be applied to improve walking autonomy in patients with Parkinson 's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Robot-assisted gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Feb 2018
- 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.
About this study
Official title: Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study
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.
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.
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.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Robot-assisted gait training
- Keywords
- Rehabilitation, Robot-assisted gait training
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
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 1.5km / 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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted gait training | Experimental | Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P\&S Mechanics Co. Ltd., Seoul, Korea) Receives: Device: Robot-assisted gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of dual-task interference: cognitive
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Measured: at 4 weeks
Percentage of dual-task interference: physical
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Measured: at 4 weeks
Secondary outcomes (9)
10 meter walk test (sec): single, cognitive dual-task, physical dual-task
Measured: baseline, at 4 weeks, at 8 weeks
Berg balance scale
Measured: baseline, at 4 weeks, at 8 weeks
Korean version of the Falls Efficacy Scale-International
Measured: baseline, at 4 weeks, at 8 weeks
Step length
Gait analysis using IMU sensors
Measured: baseline, at 4 weeks, at 8 weeks
Step width
Gait analysis using IMU sensors
Measured: baseline, at 4 weeks, at 8 weeks
Cadence
Gait analysis using IMU sensors
Measured: baseline, at 4 weeks, at 8 weeks
Vertical displacement
Gait analysis using IMU sensors
Measured: baseline, at 4 weeks, at 8 weeks
Percentage of dual-task interference: cognitive
(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Measured: baseline, at 8 weeks
Percentage of dual-task interference: physical
(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
Measured: baseline, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993042
- Sponsor's protocol ID
- RAGT-GAP
- Status last verified
- Mar 2018
- First submitted
- 6 Dec 2016
- Last updated
- 9 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02993042
- Acronym / sponsor ID
- RAGT-GAP
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Rehabilitation, Robot-assisted gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted gait training | Experimental | Device: Robot-assisted gait trainingRobot-assisted gait training using an exoskeletal robot (Walkbot_S; P\&S Mechanics Co. Ltd., Seoul, Korea) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted gait trainingPatients 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. | Device | Robot-assisted gait training |
Primary outcome
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
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
9 secondary outcomes
10 meter walk test (sec): single, cognitive dual-task, physical dual-task
Time frame: baseline, at 4 weeks, at 8 weeks
Berg balance scale
Time frame: baseline, at 4 weeks, at 8 weeks
Korean version of the Falls Efficacy Scale-International
Time frame: baseline, at 4 weeks, at 8 weeks
Step length
Time frame: baseline, at 4 weeks, at 8 weeks
Step width
Time frame: baseline, at 4 weeks, at 8 weeks
Cadence
Time frame: baseline, at 4 weeks, at 8 weeks
Vertical displacement
Time frame: baseline, at 4 weeks, at 8 weeks
Percentage of dual-task interference: cognitive
Time frame: baseline, at 8 weeks
Percentage of dual-task interference: physical
Time frame: baseline, at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training in people with Parkinson Disease and Gait Disorders, Neurologic, 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 9 Mar 2018. 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?
Percentage of dual-task interference: cognitive (time frame: at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2018.