Robot-assisted Gait Training in Patients With Parkinson's Disease
Effect of Robot-assisted Gait Training in Patients With Parkinson's Disease: a Randomized Controlled Trial
1 other identifier
interventional
44
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2019
CompletedDecember 4, 2019
December 1, 2019
1.6 years
March 21, 2018
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
10 meter walk test (sec) : single task
at 4 weeks
Secondary Outcomes (13)
10 meter walk test (sec) : single task
baseline, at 8 weeks
10 meter walk test (sec) : cognitive dual-task
baseline, at 4 weeks, at 8 weeks
10 meter walk test (sec) : physical dual-task
baseline, at 4 weeks, at 8 weeks
Berg balance scale
baseline, at 4 weeks, at 8 weeks
Timed-up & go test (sec)
baseline, at 4 weeks, at 8 weeks
- +8 more secondary outcomes
Study Arms (2)
Robot-assisted gait training
EXPERIMENTALRobot-assisted gait training using an exoskeletal robot (Walkbot\_S; P\&S Mechanics Co. Ltd., Seoul, Korea)
Intensive treadmill training
ACTIVE COMPARATORIntensive treadmill training using an usual treadmill
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (2)
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.
PMID: 34896605DERIVEDKang 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.
PMID: 30616685DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han Gil Seo, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 21, 2018
First Posted
April 6, 2018
Study Start
April 23, 2018
Primary Completion
November 14, 2019
Study Completion
November 14, 2019
Last Updated
December 4, 2019
Record last verified: 2019-12