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临床试验/NCT05443906
NCT05443906招募中不适用

Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals with Neurodegenerative Disease

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Change in NeuroQOL lower extremity

研究概览

简要总结

The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.

详细描述

This study will inform clinicians in quantitatively assessing baseline disease severity, selectively applying the appropriate exercise to the disease pathology, and measuring efficacy of the exercise intervention.

As part of this overall goal, the aims are to:

A. Determine feasibility of remotely supervised exercise programs. B. Optimize remote outcome measures for clinical monitoring and towards future clinical trials.

C. Measure changes in balance and walking post intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The eligibility criteria for males is X-linked adrenoleukodystrophy as determined by biochemical determination or genetic testing.
  • The eligibility criteria for females is X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis.
  • The Leukoenceophalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion is a confirmed DARS2 mutation through genetic analysis.
  • For people with cerebellar ataxia, people with diagnoses of cerebellar damage from stroke, tumor or degeneration will be included. Those with a genetically confirmed cerebellar disorder will be asked to provide their genetic testing to note their particular type of ataxia.
  • We will also include patients with other neurodegenerative diseases similar to these disorders as determined by chart review and clinical exam.
  • Healthy Volunteers
  • Able to stand for 30 seconds without upper extremity support
  • Ambulatory (including use of a cane or a walker)
  • Able to walk for 2 minutes

排除标准

  • Other medical or psychological conditions which in the clinical judgement of the investigator would interfere with acquiring the study information or performing the exercises safely including but not limited to:
  • Uncontrolled hypertension, orthopedic conditions, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy

研究组 & 干预措施

Home exercise

Experimental

Individually designed home exercise program

干预措施: Home exercise (Behavioral)

结局指标

主要结局

Change in NeuroQOL lower extremity

时间窗: baseline 12 weeks

Patient reported outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

jennifer keller

Physical Therapist

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

研究点 (2)

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