Drum-PD/HD: The Impact of Group Drum-Based Music Therapy Intervention on Quality of Life and Motor Symptoms in Parkinson's Disease and Huntington's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in score on anxiety level as assessed by Neuro-QoL (patients and study partner)
研究概览
简要总结
Participants in this study (18-89 years) with Parkinson's disease or Huntington's disease receive drum classes twice a week for 12 weeks (24 lessons). All participants also participate in study visits for assessments before the beginning of the study, at the 6 week mark, at the 12 week mark and at the 18 week mark so that the investigators can assess the short and long term effects of drum classes on hand dexterity, upper extremity function and well-being.
详细描述
There has been evidence that rhythm-based music therapy interventions may improve motor outcomes for patients with Parkinson's disease and Huntington's disease, as well as quality of life for both patients and the patients' caregivers. DRUM-PD, a pilot study investigating the impact of West African drumming on quality of life, symptoms, motor findings, cognition, and mood in Parkinson's disease, found trends toward improvement in walking from baseline to 12 weeks and improved quality of life for patients who completed the 6 week drumming intervention. Building on this research, the investigators plan to evaluate the impact of a 12-week, twice weekly rhythm-based music therapy intervention called The Armstrong Rhythm Cycle℠, implemented by a board-certified music therapist. The investigators hypothesize that participation in 24 bi-weekly, hour-long music therapy drumming sessions will result in improved motor functioning for patients and better quality of life for patients and the patients' caregivers as compared to baseline before the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Parkinson's Disease (PD) and Huntington's Disease (HD)
- •Ability to give written consent
- •Age 18-90
- •Clinical diagnosis of probable of clinically established Parkinson disease; or Huntington disease confirmed by genetic testing (greater than or equal to 36 CAG repeats)
- •Ability to move hands, wrists and arms safely for instrument play
- •Presence of study partner who is available for all drum lessons and study assessments
- •Study Partners:
- •Ability to give written consent
- •Ability to give written consent
- •Age 18-90
- •Ability to move hands, wrists and arms safely for instrument play
排除标准
- •PD: Hoehn & Yahr Stage 5 disease; Schwab & England score 40% or lower
- •HD: Total Functional Capacity scores between 5 and 13 inclusive
- •Co-morbid diagnosis (broken bones, sprains, severe arthritis, conditions involving paresis) in the judgement of the patient's treating physician that may preclude participant's full ability to participate in the intervention group.
- •MoCA scores <17
- •Active psychosis or other condition affecting the participants' ability to safely cooperate with study procedures
研究组 & 干预措施
Parkinson's Disease (PD) Group
Participants with PD and their caregivers receive group drum classes twice a week for 12 weeks (24 lessons).
干预措施: Group Drumming Music Therapy (Behavioral)
Huntington's Disease (HD) Group
Participants with HD and their caregivers receive group drum classes twice a week for 12 weeks (24 lessons).
干预措施: Group Drumming Music Therapy (Behavioral)
结局指标
主要结局
Changes in score on anxiety level as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For anxiety domain, unpleasant thoughts and/or feelings related to fear (e.g., fearfulness, feelings of panic), helplessness, worry and hyperarousal (e.g., tension, nervousness, restlessness) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate worse (undesirable) self-reported health.
Changes in score on depression level as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For depression domain, experience of loss and feelings of hopelessness, negative mood (e.g., sadness, guilt), decrease in positive affect (e.g., loss of interest), information-processing deficits (e.g., problems in decision-making), negative views of the self (e.g., self-criticism, worthlessness), and negative social cognition (e.g., loneliness) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate worse (undesirable) self-reported health.
Changes in score on lower extremity performance level as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For lower extremity domain, one's ability to carry out various activities involving the trunk region and increasing degrees of bodily movement, ambulation, balance, or endurance are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.
Changes in score on upper extremity performance level as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For upper extremity domain, one's ability to carry out various activities involving digital, manual and reach-related functions, ranging from fine motor to self-care (activities of daily living) are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.
Changes in score on ability to participate in social roles and activities as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For the ability to participate in social roles and activities domain, degree of involvement in one's usual social roles, activities and responsibilities, including work, family, friends, and leisure are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.
Changes in score on burden level as assessed by the Zarit Burden Interview (ZBI) (study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
The Zarit Burden Interview, a popular caregiver self-report measure used by many aging agencies, originated as a 29-item questionnaire. The 29-item instrument is included in Zarit et al., 1980. The revised version contains 22 items. This study used 22 items. It is scored as either (0) never, (1) rarely, (2) sometimes, (3) quite frequently, or (4) nearly always. Items are then summed and total scores are interpreted as follows: 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderate to severe burden, and 61 to 88 severe burden.
Changes in score on satisfaction with social roles and activities as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For the satisfaction with social roles and activities domain, satisfaction with involvement in one's usual social roles, activities and responsibilities, including work, family, friends, and leisure are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.
Changes in score on positive affect and well-being level as assessed by Neuro-QoL (patients and study partner)
时间窗: Baseline, 6 weeks, 12 weeks, and 18 weeks
Neuro-QoL is a set of self-report measures that assess the health-related quality of life (HRQOL) of adults and with neurological disorders including PD and HD. For positive affect and well-being domain, aspects of a person's life that relate to a sense of well-being, life satisfaction or an overall sense of purpose and meaning are measured. All Neuro-QoL items employ five response options (e.g., 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much) \*High scores indicate better (desirable) self-reported health.
次要结局
- Changes in score on cognitive impairment level as assessed by the MoCA (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on the daily living level as assessed by Parkinson's Disease Questionnaire (PDQ-39) (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on motor aspects of experiences of daily living level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 2) (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Change in score on depression level as assessed by the BDI-II (patients and study partner)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on patient health level as assessed by the short form (SF)-36 (patients and study partner)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on apathy level as assessed by Apathy Evaluation Scale (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on motor examination level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 3) (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on non-motor aspects of experiences of daily living level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 1) (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on motor complications level as assessed by the Movement Disorder Society (MDS) sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Part 4) (patients)(Baseline, 6 weeks, 12 weeks, and 18 weeks)
- Changes in score on activities of daily living level as assessed by the Schwab and England scale(Baseline, 6 weeks, 12 weeks, and 18 weeks)