Clinical Trial: Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study (Japan)

Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058837) titled 'Evaluation of the effectiveness of rehabilitation intervention for patients with spinocerebellar degeneration using multimodal evaluation indicators: An ongoing study' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - spinal cerebellar degeneration Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 100

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067038

Disclaimer: Curated by HT Syndication.