NL-OMON51898尚未招募不适用
Music therapy after stroke: Assessing the impact of motivation and neuroplasticity on recovery of upper-limb impairment and attention deficits. - Music therapy after Stroke
niversiteit Leiden0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Must be 18 years or older
- •- Subjects in the sub-acute group have experienced a supratentorial stroke (a
- •first and only stroke) between 2 weeks and up to 6 months before enrollment.
- •Subjects in the chronic stroke group have experienced a stroke of the middle
- •cerebral artery (MCA) (a first and only stroke) of the middle cerebral artery
- •(MCA) between 6 and 36 months at the time of enrollment, and residual
- •upper-limb impairment, indicated by a more homogenous sample for MRI
- •comparisons.
- •- Subjects in the sub-acute phase of stroke will have a referral for a paretic
- •upper limb, i.e. partial loss of the capacity to carry out a voluntary upper
- •limb movement and/or difficulty with attention, i.e. they are easily
- •distractible or unable to focus on a specific task in the presence of competing
- •information, or complain of decline in attention. Subjects in the chronic phase
- •of stroke must all have a referral for a paretic upper-limb, with or without
- •difficulty with attention.
- •-Subjects must be able to receive music therapy for a minimum of two sessions
- •per week, for a total of 9 (6 at minimum) sessions over an average of 5 weeks
- •(minimum two, maximum 8). For the subacute group the frequency of sessions is
- •based on their ability and expected length of stay.
- •- Language: Good command of Dutch or English
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Upper limb paralysis (total or very severe loss of the ability to move a
- •muscle or muscle groups of the affected upper extremity), as assessed by the
- •Medical Research Scale (MRC) for muscle strength.
- •- Severe behavioural and/or cognitive problems (a score <24 for the chronic
- •group, or <21 for the subacute group on the Mini-mental state examination;
- •MMSE) that prevent a participant from understanding instructions or being able
- •to participate in music therapy sessions, which will be confirmed as necessary
- •by the treating physician.
- •- Severe communication problems, e.g., aphasia and/or apraxia of speech, will
- •be confirmed by the treating physician.
- •- Psychiatric, substance abuse, or neurological comorbidity that may interfere
- •with the study measurements.
- •- Initiating additional new musical activities during the course of the study.
- •Additionally, participants in the chronic phase who meet the following criteria
- •will be excluded from the study, to qualify for MRI scanning:
- •- Participants who have pacemakers, brain stimulators, dental implants or
- •metallic braces, aneurysm clips (metal clips on the wall of a large artery),
- •metallic prostheses (including metal pins and rods, heart valves, and cochlear
- •implants), permanent eyeliner, insulin pumps, or shrapnel fragments, and/or
- •claustrophobia.
- •- Inability (or refusal) to remove metal objects on their person.
- •- Currently (or intending to become) pregnant, or breastfeeding throughout the
研究者
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