UMIN-CTR Clinical Trial

Public title

Longitudinal Evaluation of Activities of Daily Living in Patients with Parkinsons Disease Using Markerless Motion Analysis

Acronym

PD Markerless Motion Analysis Study

Scientific Title

Longitudinal Evaluation of Activities of Daily Living in Patients with Parkinsons Disease Using Markerless Motion Analysis

Scientific Title:Acronym

PD-ADL Markerless Longitudinal Study

Region

Japan

Condition

Parkinsons Disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to longitudinally assess activities of daily living (ADL) in patients with Parkinson's disease using an AI-based markerless motion analysis system and to characterize changes in kinematic parameters, including joint range of motion, movement time, velocity, and acceleration, according to disease severity and progression. In addition, this study will examine the associations between these kinematic parameters and conventional clinical measures, including the Hoehn and Yahr stage, the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), and the Schwab and England Activities of Daily Living Scale (S&E ADLs), and determine whether markerless motion analysis can detect longitudinal changes in ADL performance more sensitively than conventional clinical assessments.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcomes are longitudinal changes in the following kinematic parameters during activities of daily living (ADL), measured using an AI-based markerless motion analysis system:

1. Movement completion time from the initiation to the completion of each task
2. Maximum joint angles and ranges of motion of the major joints during each task
3. Movement velocity of the major joints, including peak and mean velocity
4. Movement acceleration of the major joints, including peak and mean acceleration

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients diagnosed with Parkinson's disease (PD) by a physician

2. Patients aged 18 years or older at the time of informed consent

3. Patients classified as Hoehn and Yahr stage I to III

4. Patients who can safely perform the study-related activities, including grooming, eating, dressing, standing up from a chair, and walking, with supervision or their usual assistive devices as needed

5. Patients who can understand the study procedures and provide written informed consent voluntarily

6. Patients considered eligible for participation by the principal investigator, study investigators, or attending physician

Key exclusion criteria

1. Patients with neurological diseases other than Parkinsons disease that are considered to have a substantial effect on the movements assessed in this study

2. Patients for whom safe motion assessment is considered difficult because of severe musculoskeletal disorders, cardiac disease, respiratory disease, dizziness, acute illness, or other systemic conditions

3. Patients who have difficulty understanding the study, providing written informed consent, or performing the assessment tasks because of impaired cognitive function or communication ability

4. Patients for whom assessment is considered inappropriate because of pain, marked fatigue, fever, or other poor physical conditions

5. Patients considered unsuitable for participation by the principal investigator, study investigators, or attending physician

Target sample size

100

Name of lead principal investigator

1st name	Yuji
Middle name
Last name	Inagaki

Organization

Hokkaido University

Division name

Division of Rehabilitation Science

Zip code

0600812

Address

Kita 12-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan

TEL

0117063335

Email

y.inagaki@pop.med.hokudai.ac.jp

Name of contact person

1st name	Yuji
Middle name
Last name	Inagaki

Organization

Faculty of Health Sciences, Hokkaido University, Japan

Division name

Division of Rehabilitation Science

Zip code

0600812

Address

Kita 12-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Japan

TEL

0117063335

Homepage URL

Email

y.inagaki@pop.med.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Yuji Inagaki

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Faculty of Health Sciences, Graduate School of Health Sciences, Hokkaido University

Address

Kita 12-jo Nishi 5-chome , Kita-ku, Sapporo, Hokkaido, Japan

Tel

0117063335

Email

y.inagaki@pop.med.hokudai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

08

Month

10

Day

Date of IRB

Anticipated trial start date

2026

Year

09

Month

10

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a prospective longitudinal observational study involving patients with Parkinsons disease. Patients who are hospitalized or receive outpatient care at participating institutions and who meet the inclusion criteria without meeting any exclusion criteria will be invited to participate.

Activities of daily living will be longitudinally assessed using an AI based markerless motion analysis system. Motion related parameters including movement completion time, joint angles and ranges of motion of major joints, movement velocity, acceleration, bilateral differences, movement trajectories, movement variability, and the time required for each phase of the task will be evaluated.

Clinical assessments, including the Hoehn and Yahr stage, MDS UPDRS, and the Schwab and England Activities of Daily Living Scale, will also be collected. Longitudinal changes in motion related parameters and their associations with clinical assessments will be examined.

Registered date

2026

Year

08

Month

10

Day

Last modified on

2026

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071591