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临床试验/NCT06804304
NCT06804304招募中不适用

Efficacy of Music-Based Telerehabilitation After Stroke

Teppo Sarkamo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change in the cognitive functioning summary score from baseline to 3-month stage
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to learn if a music-based telerehabilitation intervention implemented at home works to treat different kinds of neurological deficits caused by stroke. The main questions it aims to answer are: 1) Can the music intervention improve recovery of cognitive, verbal, motor, and emotional deficits after stroke, 2) can the music intervention enhance structural and functional recovery of the brain, and (3) how different demographic, musical, and clinical background factors affect the way the music intervention works. Researchers will compare the music intervention to standard (usual) care to see if the music intervention works to treat the deficits caused by stroke. Subjects are stroke patients who will participate either in the music intervention 5 times/week for 10 weeks in addition to standard care or receive standard care only. During the trial, the subjects will undergo neuropsychological testing and magnetic resonance imaging (MRI) three times: at baseline (before the intervention), at 3-month stage (immediately after the intervention), and at 6-month stage (3 months after the intervention).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Left or right hemisphere stroke which has occurred at least 3 months ago
  • •At least mild cognitive deficit and mild aphasia / upper-extremity hemiparesis caused by the stroke
  • •Age 30-80 years
  • •Finnish-speaking (or bilingual, able to participate in Finnish)
  • •Understands the purpose of the study and is able to give informed consent

排除标准

  • •Prior significant hearing or visual impairment
  • •Prior severe psychiatric illness (e.g., schizopheria, bipolar disorder, severe unipolar depression)
  • •Prior severe neurological illness (e.g., brain injury, dementia; can have prior TIA or mild stroke)

研究组 & 干预措施

Music intervention plus standard care

Experimental

Participation in a music-based telerehabilitation program (10 weeks, 5 days/week, 60 min/day) in addition to standard care for post-stroke deficits provided in public health care (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation).

干预措施: Music-based telerehabilitation (Behavioral)

Standard care only

No Intervention

Standard care for post-stroke deficits provided in public health care (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation). No additional intervention is provided.

结局指标

主要结局

Change in the cognitive functioning summary score from baseline to 3-month stage

时间窗: Baseline and 3-month stage

Cognitive functioning summary score is calculated as an average of rescaled scores in following tests: Montreal Cognitive Assessment (MoCA) total score, MoCA Verbal Fluency subtest total score, Sustained Attention to Response Task (SART; correct responses \& reaction times), Flexible Attention Test (FAT) / Reaction Time subtest (reaction times) and Trail Making subtest (correct responses \& reaction times from difference scores between B part and A part), Simon Task (correct responses \& reaction times from difference scores between Incongruence part and Congruence part), and Wechsler Memory Scale III (WMS-III) / Digit Span subtest (total score) and Spatial Span subtest (total score). Raw scores are rescaled to a scale of 0-100 using min-max normalization \[(x-min(x))/(max(x)-min(x))\*100\] across the measurement points. The range of the summary score is 0-100 (higher score indicates better outcome).

Change in the speech production summary score from baseline to 3-month stage

时间窗: Baseline and 3-month stage

Speech production summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in the following subtests of the Western Aphasia Battery (WAB): Conversational Question, Picture Description, Repetition, Object Naming, Word Fluency, Sentence Completion, and Responsive Speech. The range of the summary score is 0-100 (higher score indicates better outcome).

Change in the upper-extremity motor function summary score from baseline to 3-month stage

时间窗: Baseline and 3-month stage

Upper-extremity motor function summary score is calculated as an average of percentage of correct responses (score/maximum value\*100; range 0-100) in following tests: Action Research Arm Test (ARAT; total score), Box and Block Test (BBT; total score), and Purdue Pegboard Test (PPT; total score). The range of the summary score is 0-100 (higher score indicates better outcome).

Change in the mood and quality of life summary score from baseline to 3-month stage

时间窗: Baseline and 3-month stage

Mood and quality of life summary score is calculated as an average of percentage scores (score/maximum value\*100; range 0-100) in following self-report questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) / Depression scale (total score), PROMIS / Anxiety scale (total score), and Stroke Impact Scale (SIS; total score). The scores of the PROMIS are reversed to align with the SIS scores. The range of the summary score is 0-100 (higher score indicates better outcome).

次要结局

  • Change in the WMS-III Digit Span subtest (forward recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (1st learning trial score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Spontaneous speech score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BBT total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Mobility subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the cognitive functioning summary score from baseline to 6-month stage(Baseline and 6-month stage)
  • Change in the speech production summary score from baseline to 6-month stage(Baseline and 6-month stage)
  • Change in the ARAT Grip subscale score (paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the upper-extremity motor function summary score from baseline to 6-month stage(Baseline and 6-month stage)
  • Change in the mood and quality of life summary score from baseline to 6-month stage(Baseline and 6-month stage)
  • Change in the attention summary score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the executive function summary score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the working memory summary score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the MoCA total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the MoCA Verbal Fluency subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the SART correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the SART reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Reaction Time subtest reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (B part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (A part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (A part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (B part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (difference between B part and A part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the FAT Trail Making subtest (difference between B part and A part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (Congruence part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (Congruence part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (Incongruence part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (Incongruence part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (difference between Incongruence part and Congruence part) correct responses from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the Simon Task (difference between Incongruence part and Congruence part) reaction times from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Digit Span subtest (backward recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Digit Span subtest (total score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Spatial Span subtest (forward recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Spatial Span subtest (backward recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Spatial Span subtest (total score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (learning trials change score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (learning trials total score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (learning trials recognition score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (delayed recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WMS-III Word Lists subtest (delayed recognition score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the RBMT Story Recall subtest (immediate recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the RBMT Story Recall subtest (immediate recognition score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the RBMT Story Recall subtest (delayed recall score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the RBMT Story Recall subtest (delayed recognition score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BIT Star Cancellation subtest (left side score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BIT Star Cancellation subtest (right side score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BIT Star Cancellation subtest (laterality index) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BIT Star Cancellation subtest (total score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Conversational Question subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Conversational Question & Picture Description subtests (information content score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Conversational Question & Picture Description subtests (fluency of speech score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Conversational Question & Picture Description subtests (efficiency score) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Repetition subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Object Naming subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Word Fluency subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Sentence Completion subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Responsive Speech subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Naming and Word Finding score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the WAB Sequential Commands subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BDAE Verbal Agility subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BDAE Automatized Sequences subtest score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Grasp subscale score (paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Grasp subscale score (non-paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Grip subscale score (non-paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Pinch subscale score (paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Pinch subscale score (non-paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Gross Movement subscale score (paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT Gross Movement subscale score (non-paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT total score (paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the ARAT total score (non-paretic hand) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BBT paretic hand score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the BBT non-paretic hand score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the PPT paretic hand score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the PPT non-paretic hand score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the PPT both hands score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the PPT total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in the PPT Assembly score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in PROMIS Depression subscale total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in PROMIS Anxiety subscale total score from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Strength subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Hand Function subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS ADL subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Mobility subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Communication subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Emotion subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Memory and Thinking subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Participation subscale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Recovery item score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS total score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Strength subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Hand Function subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS ADL subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Communication subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Emotion subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Memory and Thinking subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Participation subscale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS Recovery item score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in SIS total score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in MAL total score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in MAL total score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL total score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL Quantity of Communication scale score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL Quality of Communication score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL total score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL Quantity of Communication scale score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CAL Quality of Communication score (proxy report of family member) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in CFQ total score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)
  • Change in PRMQ total score (patient self-report) from baseline to 3-month and 6-month stages(Baseline, 3-month stage, and 6-month stage)

研究者

发起方
Teppo Sarkamo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Teppo Sarkamo

Professor

University of Helsinki

研究点 (1)

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