UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058837 |
|---|---|
| Receipt number | R000067038 |
| Scientific Title | Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/19 13:47:29 |
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Basic information
Public title
Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study
Acronym
Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study
Scientific Title
Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study
Scientific Title:Acronym
Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study
Region
| Japan |
Condition
Condition
spinal cerebellar degeneration
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Spinal cerebellar degeneration (SCD) is a progressive disease characterized by atrophy of the cerebellum. In recent years, the efficacy of rehabilitation as a treatment intervention has garnered attention. Our research group has also demonstrated the efficacy of concentrated balance training. The next challenge is to identify which aspects of the pathophysiology of SCD are influenced by rehabilitation intervention.
This requires a multidisciplinary approach that integrates medical, engineering, and computational methodologies. The objectives of this study are: 1) to conduct both conventional scoring evaluations and engineering/computational motion analyses simultaneously to clarify the effects of rehabilitation interventions, and 2) to use simple sensing technologies to seamlessly measure participants' walking, standing, and upper limb activities at home and in the hospital, thereby elucidating the effects of rehabilitation interventions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Ataxia assessment using infrared and laser depth cameras
2. Rhythm disorder assessment
3. Gait and standing analysis
4. Gait measurement using accelerometers and gyroscopes in smartphones and Bluetooth-connected earphones
5. Markerless motion capture using deep learning with clinical videos from RGB cameras
6. Standing adaptation learning tasks using an external stimulus device
Key secondary outcomes
Established evaluation items The following evaluations are basically the evaluation items necessary for clinical practice. Since SCD has a wide range of symptoms, not all evaluations are performed on all cases. Clinically, the necessary evaluation items are selected from among these for each patient. Physical therapists, occupational therapists, and speech-language pathologists collaborate to perform the following evaluations. 1. Edinburgh Handedness Test
2. Scale for the Assessment and Rating of Ataxia (SARA)
3. Balance Evaluation Systems Test
4. Simple Test for Evaluating Hand Function (STEF)
5. 9-Hole Peg Test
6. Mini Mental State Examination (MMSE)
7. Frontal Assessment Battery (FAB)
8. Gait Efficacy Scale
9. Activities-specific Balance Confidence (ABC) Scale
10. Grip Strength and Pinch Strength
11. Purdue Pegboard Test
12. Box and Block Test
13. Trail Making Test-J
14. Kana Collection Test
15. FIM
16. EQ-5D
17. Medical Expenses
18. Speech sound production test
19. Standard Daytime Speech Test (AMSD)
20. Voice Handicap Index: Japanese version (VHI-)
21. Monologue (Momotaro)
22. Acoustic analysis (instrumental analysis)
23. Auditory impression test
24. Swallowing function assessment
25. Schmahmann syndrome scale
26. Respiratory function test
27. MRI image
28. Unified Multiple Systems Atrophy Rating Scale (UMSARS)
29. Scale for Ocular motor Deficits in Ataxia (SODA)
30. Ataxia Functional Composite Scale (AFCS)
31. Composite Cerebellar Functional Severity Score (CCFS)
32. SCA Functional Index (SCAFI)
33. Friedreich ataxia rating scale-activity of daily living (FARS-ADL)
34. Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia)
35. Score of Integrated Balance for Ataxia
36. Patient-reported satisfaction questionnaire
37. Profile of Mood States 2nd Edition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Rehabilitation interventions for patients with spinocerebellar degeneration are conducted within the scope of normal clinical practice and do not require the use of special medical equipment. Interventions are carried out as deemed necessary by the rehabilitation physician. Rehabilitation interventions for patients with this disease are also conducted within the scope of clinical practice deemed necessary by the rehabilitation physician.
Interventions/Control_2
Forty healthy adults matched for age and gender will be evaluated, along with 100 other patients with neurological disorders (Parkinson's disease-related disorders, autoimmune disorders) who are receiving treatment at our hospital's neurology department. Rehabilitation interventions within the normal clinical range will be implemented as needed, in the same manner as in the intervention group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study includes patients diagnosed with SCD at a medical institution (including those with an undetermined causative gene). Additionally, patients diagnosed with spinocerebellar degeneration or MSA-C by our neurology department are included. Criteria such as disease stage or duration of illness are not set to capture the distribution of evaluation results.
Control group
1. Healthy adults matched with the study participants in terms of age and gender
Patients with neurological disorders other than SCD who are under the care of our Department of Neurology (e.g., Parkinson's disease-related disorders, autoimmune diseases)
To clearly distinguish from cerebellar disorders
2. Individuals who have received an explanation of the study and have provided informed consent to participate as volunteers.
Key exclusion criteria
1) Severe heart disease: unstable angina, myocardial infarction within a short period after onset, decompensated congestive heart failure,
uncontrolled arrhythmia, severe aortic stenosis, active myocarditis, endocarditis, etc.
2) Uncontrolled hypertension
3) Acute systemic disease or fever
4) Recent pulmonary embolism, acute pulmonary edema, or severe pulmonary hypertension
5) Severe liver or kidney dysfunction
6) Severe cognitive impairment or severe mental illness
7) Other conditions deemed inappropriate by the principal investigator
8) Patients with a cardiac pacemaker, pacemaker electrodes, metallic heart valves, or metallic clips from brain aneurysm surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Neurology
Zip code
1878551
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
TEL
0423412711
yutakahashi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Neurology
Zip code
1878551
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
TEL
0423412711
Homepage URL
yutakahashi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawa higashi, Kodaira ,Tokyo
Tel
0423412711
ml_rinri-jimu@ncnp.go.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 | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 01 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067038
