| 基本情報/Basic information |
| 一般向け試験名/Public title |
脊髄小脳変性症における認知機能障害に対するリハビリテーションの効果について |
Effects of rehabilitation on cognitive dysfunction in spinocerebellar degeneration |
| 一般向け試験名略称/Acronym |
脊髄小脳変性症のリハビリテーション効果の検討 |
Examination of rehabilitation effect of spinocerebellar degeneration |
| 科学的試験名/Scientific Title |
純粋小脳型脊髄小脳変性症における認知機能障害に対するリハビリテーションの効果について |
Effects of intensive exercise on cognitive dysfunction in patients with pure cerebellar degeneration: a single-arm pilot study |
| 科学的試験名略称/Scientific Title:Acronym |
純粋小脳型脊髄小脳変性症のリハビリテーション効果の検討 |
Effect of exercise on cognitive dysfunction in SCD |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
4週間のリハビリテーションの実施
週に6回
一日3時間のリハビリテーション
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4 weeks of rehabilitation
6 times a week
3 hours a day rehabilitation |
| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
脊髄小脳変性症を有する人 |
Patients with spinocerebellar degeneration |
| 除外基準/Key exclusion criteria |
脳卒中、うつ病、重症感染症を含む合併症、深部静脈血栓症、歩行中に痛みを引き起こす整形外科疾患、不安定狭心症、運動中に呼吸困難を引き起こす心肺疾患、および冠動脈バイパス移植を行ったものは除外する。 |
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. |
| 目標参加者数/Target sample size |
16 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000045633 |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
16 |
| 主な結果/Results |
○運動機能とADL
SARAスコアは、運動後に10.7点から8.1点へと有意に改善した。BBSスコアは、運動後に43.6点から48.8点へと有意に上昇した。FIMスコアは，運動後に119.7点から122.3点へと有意に上昇した。
○認知機能
MMSEスコアは、運動後に27.7点から29.0点へと有意に改善した。FABスコアは、運動後に14.8点から15.8点へと有意に上昇した。MoCA-Jスコアは、運動後に24.6点から26.7点へと有意に上昇した。
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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.
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| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
専門の神経内科医がDNA分析の結果に基づいて特定した純粋な小脳型（CCA、SCA6、SCA31）のSCDと診断された患者を登録した。患者は自立した日常生活動作（ADL）と歩行が可能であることが研究の対象となった。除外基準は、磁気共鳴画像およびVoxel-based specific regional analysis system for Alzheimer's disease（VSRAD）における小脳内以外の異常、筋力低下、著しい可動域制限、表在・深在を含む感覚障害、前庭機能障害、他の疾患による運動機能障害、精神疾患などであった。 |
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.
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| 参加者の流れ/Participant flow |
本試験は、認知機能の評価については対照群を設けた比較試験であったが、運動介入後の評価については介入群のみで比較群を設けないシングルアームのパイロット試験であった。対照群の各参加者は、認知機能テストを受けた。患者群の参加者は、入院時に認知機能、運動機能、ADLの評価を受けた。その後、集中的な運動療法の後に再び同じ評価を行い、運動の効果を評価した。 |
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. |
| 有害事象/Adverse events |
有害事象は認められていない。
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No adverse events were observed. |
| 評価項目/Outcome measures |
○運動機能及びADL評価
1) Scale for the Assessment and Rating of Ataxia (SARA)
2) Berg Balance Scale (BBS)
3) Functional Independence Measure (FIM).
○認知機能評価
1) Mini-Mental State Examination (MMSE)
2) Frontal Assessment Battery (FAB)
3) Montreal Cognitive Assessment-Japanese (MoCA-J).
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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).
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| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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