Effects of Telerehabilitation on the Occupational Performance of Stroke Patients Treated by an Occupational Therapy Service: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in "Katz Index of Independence in Activities of Daily Living" score indicating greater independence or dependence in performing basic activities of daily living after 2 months.
研究概览
简要总结
The objective of this randomized clinical trial is to evaluate the effects of using telerehabilitation (remote care) by occupational therapists on improving the performance and recovery of patients within the Brazilian Unified Health System (SUS) who have suffered a stroke and are on a waiting list for specialized rehabilitation care.
The main question it seeks to answer is:
- What are the effects of occupational therapy services provided through telerehabilitation for the population with stroke sequelae?
- Do the guidelines provided by telerehabilitation result in improved occupational performance (ability to perform activities of daily living) of the participants?
The researchers compare an experimental group (receiving telerehabilitation treatment) with a waitlist group (which will remain on the waitlist without receiving a specific intervention).
Participants are required to:
- Answer a sociodemographic questionnaire;
- Participate in assessments using standardized scales on basic and instrumental activities of daily living and use of the affected limb (Instrumental Activities of Daily Living Scale, Katz Scale, and Motor Activity Log).
- Receive and apply Occupational Therapy guidelines (if in the intervention group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Clinically stable
- •Diagnosis of sequelae of stroke (regardless of modified Rankin scale score)
- •On a waiting list with medical indication for Occupational Therapy at IMREA HCFMUSP
- •Access to a computer, tablet, or smartphone with internet connection allowing for video calls
- •Ability to understand the Portuguese language
- •Availability of a caregiver to assist during therapy sessions, if necessary
排除标准
- •Clinically unstable patients (e.g., frail elderly with decompensated chronic diseases)
- •High-risk pregnant women
- •Lack of access to internet or devices required for telerehabilitation
- •Absence of a caregiver when assistance is required for sessions
研究组 & 干预措施
Telerehabilitation
Participants in this group receive Occupational Therapy guidance via telehealth (telerehabilitation) focused on improving occupational performance.
干预措施: Telerehabilitation in Occupational Therapy (Behavioral)
Waiting List
Participants allocated to this group remains on the waiting list for occupational therapy, following the natural course of functional improvement.
结局指标
主要结局
Change in "Katz Index of Independence in Activities of Daily Living" score indicating greater independence or dependence in performing basic activities of daily living after 2 months.
时间窗: From enrollment to the end of treatment at 8 weeks
The Katz Index (Brazilian version) assesses functional status in six activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6. In this specific version, 0 indicates full independence (best outcome) and 6 indicates full dependence (worst outcome). Therefore, lower scores indicate a better outcome.
Change in "Lawton Instrumental Activities of Daily Living" score indicating greater independence or dependence in performing instrumental activities of daily living after 2 months.
时间窗: From enrollment to the end of treatment at 8 weeks
The Lawton Scale (Brazilian version) assesses independent living skills such as using the phone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for their own medications, and ability to handle finances. Scores range from 7 to 21. Higher scores indicate greater independence (better outcome).
Change in "Motor Activity Log" score for quantitative and qualitative analysis of the use of the affected upper limb.
时间窗: From enrollment to the end of treatment at 8 weeks
The MAL (Brazilian version) scale assesses how well the patient uses the affected upper limb. Participants rate the quality of movement on a scale from 0 (The weaker arm is not used) to 5 (Ability to use the weaker arm is just as good as before the stroke). The final score is the mean of the items. Higher scores indicate better movement quality (better outcome).
次要结局
未报告次要终点
研究者
André Tadeu Sugawara
Principal Investigator
University of Sao Paulo