UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057662 |
|---|---|
| Receipt number | R000065865 |
| Scientific Title | The Effects of Limb Coordination Training on Gait Disturbances in Patients with Parkinsons Disease A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/20 14:20:34 |
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Basic information
Public title
The Effects of Limb Coordination Training on Gait Disturbances in Patients with Parkinsons Disease A Randomized Controlled Trial
Acronym
The Effects of Limb Coordination Training on Gait Disturbances in Patients with Parkinsons Disease A Randomized Controlled Trial
Scientific Title
The Effects of Limb Coordination Training on Gait Disturbances in Patients with Parkinsons Disease A Randomized Controlled Trial
Scientific Title:Acronym
The Effects of Limb Coordination Training on Gait Disturbances in Patients with Parkinsons Disease A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Parkinsons Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of active limb coordination exercises using a seated coordination training device in improving gait dysfunction in patients with Parkinsons disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait assessment using a seat-type lower limb load measurement system (WalkWay-MW-1000, ANIMA Corp.), focusing on gait speed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Active limb coordination exercises using a seated coordination training device will be performed. Each participant will undergo both high-amplitude and rhythmic training, and the immediate effects of each intervention will be compared. The order of the exercises will be randomly assigned. The intensity of the training will be gradually adjusted based on individual tolerance, and all sessions will be supervised by rehabilitation staff.
Interventions/Control_2
Participants assigned to the intervention group received active limb coordination training using a seated coordination exercise device. The training consisted of rhythmic and high-amplitude reciprocal movements of the upper and lower limbs and was performed for 30 minutes per session, three times a week, over a period of four weeks. The intensity and range of motion were progressively adjusted based on each participants tolerance and performance. All sessions were conducted under the supervision of qualified rehabilitation staff to ensure safety and adherence to the protocol.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with a possible diagnosis of Parkinsons disease made by a neurologist with expertise in PD and other movement disorders
2.Diagnosis of PD with Hoehn and Yahr stage I to II
3.Patients whose medication regimen has been stable for at least one month
4.Ability to walk independently for more than 10 meters
5.Male or female participants aged 18 years or older
6.Provision of written informed consent
Key exclusion criteria
1.Patients with dementia, defined as a Mini-Mental State Examination (MMSE) score of 24 or below
2.Patients unable to participate in consistent training or physical performance assessments due to alcohol or substance abuse, active depression, anxiety disorders, or psychosis
3.Patients with coexisting neurological or orthopedic conditions that interfere with mobility or exercise
4.Patients with a history of neurosurgical procedures
5.Patients with cardiovascular or pulmonary diseases that may interfere with the training
6.Patients who have participated in another clinical trial within the past six months
7.Any other condition that the principal investigator deems inappropriate for study participation
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Matsuse |
Organization
Kyushu University Hospital
Division name
Department of Neurology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL
+81-92-642-5862
matsuse.dai.302@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Tanaka |
Organization
Kyushu University Hospital
Division name
Department of Rehabilitation
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
TEL
+81-92-642-5862
Homepage URL
tanaka.tomoaki.132@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research, Kyushu University Hospital (ARO Center)
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,Japan
Tel
092-642-5858
tr-info@med.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | 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
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065865
