Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Motor Activity Log (MAL) Score
研究概览
简要总结
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.
详细描述
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke Survivors
- •One month to five years post ischemic or hemorrhagic event
- •Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
- •Mini-mental screening test score of greater than 24
- •Presence of a care partner
- •At least 18 years old
- •Ability to read and write English
- •Mini-mental screening test score of greater than 24
排除标准
- •Stroke Survivors
- •Severe cognitive deficits
- •Significant cognitive deficits
结局指标
主要结局
Motor Activity Log (MAL) Score
时间窗: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Upper extremity function and use will be assessed using the Motor Activity Log (MAL). The MAL is a semi-structured interview to assess arm function. Participants are asked to rate quality of movement (QOM) during 28 daily functional tasks. Items are scored on a 6-point ordinal scale, from 0 to 5, where 0 = the affected arm was of no use and 5 = affected arm is functioning normally. The total score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke.
Family Caregiver Conflict Scale (FCCS) Score
时间窗: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Family conflict will be assessed using the Family Caregiver Conflict Scale (FCCS). The FCCS is 15-item scale that measures family conflict between caregivers and other family by assessing disagreements over caring for the care recipient with items such as: "We have disagreements when I ask family members to help me take care of our relative." Items are scored from 1 to 7 where 1 = not true at all and 7 = very true. total scores range from 15 to 105 and higher scores indicate greater family conflict.
Wolf Motor Function Test (WMFT)
时间窗: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Motor ability and impairments will be assessed using the Wolf Motor Function Test (WMFT) an assessment tool used to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. Values represent the amount of time, in seconds, to complete the assessment. Lower scores (faster speed) are indicative of higher functioning levels.
Center for Epidemiologic Studies Depression Scale (CES-D) Score
时间窗: Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)
Depressive symptoms among carepartners will be assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a screening test for depression and depressive disorder. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the last week. Each item is scored from 0 to 3 where 0 = rarely and 3 = most days and certain items are reverse scored so that greater symptomatology is assigned a higher score. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. Scores of 16 or greater are considered as an indicator of potential clinical depression.
次要结局
- Caregiver Strain Index (CSI) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Bakas Caregiving Outcomes Scale (BCOS) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Confidence in Arm and Hand (CAHM) Scale Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Stroke Impact Scale (SIS) Score(Baseline, 1 Month Post-treatment (up to Week 7))
- Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Piper Fatigue Scale (PFS) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Caregiving Self Efficacy (Obtaining Respite Scale) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Post Study System Usability Questionnaire (PSSUQ) Score(Post-treatment (up to Week 3))
- Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
- Fugl-Meyer Assessment (FMA) Score(Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7))
研究者
Sarah Blanton
Associate Professor
Emory University