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

NCT ID: NCT03490578

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2019-11-14

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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot-assisted gait training

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

Group Type: EXPERIMENTAL

Robot-assisted gait training

Intervention Type: 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 1.0 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 training

Intensive treadmill training using an usual treadmill

Group Type: ACTIVE_COMPARATOR

Intensive treadmill training

Intervention Type: DEVICE

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.

Interventions

Robot-assisted gait training

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.

Intervention Type: DEVICE

Intensive treadmill training

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Gil Seo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Han Gil Seo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 34896605 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30616685 (View on PubMed)

Other Identifiers

RAGT-PD1.0

Identifier Type: -

Identifier Source: org_study_id