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A Randomized Controlled Trial on the Safety and Effectiveness of Interventions Using a Passive Walking Assist Device for Parkinson's Disease

Evaluation of the Safety and Effectiveness of a Passive Walking Assist Device for Patients with Parkinson's Disease: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250062
Enrollment
24
Registered
2025-04-24
Start date
2025-04-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

The aLQ training group: The session consists of a 5-minute warm-up, 3 minutes for attaching the aLQ as preparation for walking, 10 minutes of flat-surface walking practice, a 5-minute break, another 1

Sponsors

Daida Hiroyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)The patient, diagnosed with Parkinson's disease at the time of consent acquisition, is at Hoehn and Yahr stage II (bilateral involvement is present, but there is no postural instability. There is some impairment in daily activities and occupation, but the patient is still able to perform them) to stage III (postural instability is observed. The functional impairment is mild to moderate, but the patient is still able to live independently). 2)Patients aged 30 years or older but under 79 years at the time of consent acquisition. 3)When the effects of Parkinson's disease (PD) medication have worn off - meaning the therapeutic benefits previously achieved through medication administration diminish or disappear over time, resulting in the reappearance of symptoms - the patient demonstrates a Functional Ambulation Category (FAC) level of 2. At this level, one-person assistance is required for ambulation on level ground to prevent falls; the assistance must be continuous and include balance support, physical guidance, and weight-bearing aid.In contrast, when the effects of PD medication are sustained - meaning the therapeutic benefits achieved through medication administration are maintained over a certain period without diminishing - the patient demonstrates a FAC level of 5, indicating independent ambulation on level ground, uneven terrain, stairs, and slopes. 4)A patient who exhibits characteristic PD gait disturbances, such as asymmetry, freezing of gait, and shuffling steps, when the effects of PD medication are off, but lives independently using walking without reliance on a wheelchair. 5)A patient who is capable of walking for more than 10 minutes in daily life when the effects of PD medication are sustained. 6)Patients who are able to attend outpatient visits. 7)Patients with the capacity to consent, able to provide written informed consent voluntarily. 8)Patients judged by the principal investigator or sub-investigator to be suitable for evaluating the efficacy and safety of this study, based on the inclusion and exclusion criteria.

Exclusion criteria

Exclusion criteria: 1)Patients with a history of central nervous system disorders other than Parkinson's disease (PD) or lower limb joint disorders that affect walking. 2)Patients with dementia, defined as an MMSE score of less than 20. 3)Patients restricted from physical activity by their physician. 4)Patients who are pregnant or may be pregnant. 5)Other patients deemed unsuitable as study participants by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Fall Incidence Rate During Walking Practice Definition of Fall Incidence: Falls are defined during walking practice under the supervision of a physical therapist as follows: 1.The toes catch on the floor. 2.One step is taken during lateral weight shifting. 3.Assistance is provided due to the risk of falling. 4.Walking is temporarily stopped due to the risk of falling. The number of fall incidences is recorded by counting the occurrences of events 1-4 during walking practice. (Fall Incidence Rate = Number of individuals experiencing falls / Total number of participants in the group.)

Secondary

MeasureTime frame
1.Change in MDS-UPDRS Part III score from the initial assessment (post-intervention assessment and final assessment). 2.Change in mini-BESTest (Balance Evaluation Systems Test) score from the initial assessment (post-intervention assessment and final assessment). 3.Change in 30-second sit-to-stand test score from the initial assessment (post-intervention assessment and final assessment). 4.Change in grip strength from the initial assessment (post-intervention assessment and final assessment). 5.Gait assessment: Changes from the initial evaluation in gait speed, step length, stride length, and joint angles during walking.(recorded at each walking practice session, post-intervention assessment, and final assessment). 6.Change in joint angles during standing posture from the initial assessment (post-intervention assessment and final assessment). 7.Change in walking distance from the initial assessment (recorded at each walking practice session, post-intervention assessment, and final assessment). 8.PDQ-39 scores (initial assessment, post-intervention assessment, and final assessment). 9.Fear of falling, assessed using the Falls Efficacy Scale-International (FES-I) (initial assessment, post-intervention assessment, and final assessment). 10.Occurrence of disease-related events or complications. 11.Occurrence of muscle pain during or after walking practice. 12.Occurrence of skin redness at the aLQ attachment site.

Contacts

Public ContactTadamitsu Matsuda

Juntendo University

t.matsuda.ye@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026