UMIN-CTR Clinical Trial

Basic information
Public title	Effects of rehabilitation on cognitive dysfunction in spinocerebellar degeneration
Acronym	Examination of rehabilitation effect of spinocerebellar degeneration
Scientific Title	Effects of intensive exercise on cognitive dysfunction in patients with pure cerebellar degeneration: a single-arm pilot study
Scientific Title:Acronym	Effect of exercise on cognitive dysfunction in SCD
Region	Japan

Condition
Condition	spinocerebellar degeneration
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether rehabilitation is effective for cognitive dysfunction in spinocerebellar degeneration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function evaluation Evaluate before intervention and after 4 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	4 weeks of rehabilitation 6 times a week 3 hours a day rehabilitation
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

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with spinocerebellar degeneration
Key exclusion criteria	Exclusion criteria included history of stroke, depression, complications including severe infection, deep vein thrombosis, orthopedic diseases causing pain during gait, unstable angina and cardiopulmonary disease causing dyspnea during exercise, and recent history of surgical intervention, including coronary artery bypass graft.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Toshiya Middle name Last name Shimamoto
Organization	kumamoto southern regional hospital
Division name	department of rehabilitation
Zip code	861-4214
Address	mu-banchi mainohara jhonan-machi minami-ku kumamoto
TEL	0964-28-2555
Email	sentyoukansetu@icloud.com

Public contact
Name of contact person	1st name Toshiya Middle name Last name Shimamoto
Organization	kumamoto southern regional hospital
Division name	department of rehabilitation
Zip code	861-4214
Address	mu-banchi mainohara jhonan-machi minami-ku kumamoto
TEL	0964-28-2555
Homepage URL
Email	sentyoukansetu@icloud.com

Sponsor
Institute	kumamoto southern regional hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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	2020 Year 04 Month 30 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000045633
Publication of results	Published

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000045633
Number of participants that the trial has enrolled	16
Results	Motor function and ADL SARA scores significantly improved from 10.7 to 8.1 points after exercise. BBS scores significantly increased from 43.6 to 48.8 points after exercise. FIM scores significantly increased from 119.7 to 122.3 points after exercise. Cognitive function MMSE scores significantly improved from 27.7 to 29.0 points after exercise. FAB scores significantly increased from 14.8 to 15.8 points after exercise. MoCA-J scores significantly increased from 24.6 to 26.7 points after exercise.
Results date posted	2021 Year 10 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We enrolled patients diagnosed with SCD of the purely cerebellar type, identified by an expert neurologist based on the results of DNA analysis. Patients had to be capable of independent activities of daily living and walking in order to be eligible for the study. Exclusion criteria included any abnormalities other than those within the cerebellum on magnetic resonance imaging and voxel based specific regional analysis system for Alzheimer disease, muscle weakness, marked range of motion limitation, sensory deficits including superficial deep sensation, vestibular dysfunction, motor dysfunction due to other diseases, and mental illness.
Participant flow	This study was a comparative study with a control group for the assessment of cognitive function, but a single-arm pilot study with only an intervention group and no comparison group for the assessment after the exercise intervention. Each participant in the control group underwent cognitive function tests. Participants in the patient group underwent cognitive and motor function and ADL assessments on admission. The same assessments were then performed again after intensive exercise therapy to evaluate the effect of exercise.
Adverse events	No adverse events were observed.
Outcome measures	Evaluation of motor function and ADL 1) Scale for the Assessment and Rating of Ataxia (SARA) 2) Berg Balance Scale (BBS) 3) Functional Independence Measure (FIM). Evaluation of cognitive function 1) Mini-Mental State Examination (MMSE) 2) Frontal Assessment Battery (FAB) 3) Montreal Cognitive Assessment-Japanese (MoCA-J).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 01 Month 10 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry	2020 Year 01 Month 30 Day
Date trial data considered complete	2020 Year 01 Month 30 Day
Date analysis concluded	2021 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 04 Month 06 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045633

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2021/04/22	UMIN英語登録用.xlsx

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