Smart Soulitions: A Single-blind Randomized Controlled Trial Comparing Smartphone-based Home Exercise to the Paper-based Standard of Care on Pelvic Floor Muscle Weakness Outcomes and Home Exercise Adherence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pelvic Floor Distress Inventory short-form 20 (PFDI-20)
研究概览
简要总结
The goal of this randomized clinical trial is to investigate the impact of a smartphone-based application on patient-reported outcomes for patients with pelvic floor muscle weakness, and the relationship of patient adherence to outcomes in pelvic floor physical therapy compared to the paper-based standard of care.
An additional aim is the exploration and development of two patient-reported questionnaires to enhance understanding of exercise adherence in outpatient pelvic floor physical therapy and smartphone application self-efficacy. These goals will serve to improve practice recommendations for home exercise prescriptions in this patient population.
Participants will be asked to complete 6 patient-reported outcome measures after they complete four, 60-minute long physical therapy treatment sessions conducted one time per week according to the current standard of care for pelvic floor physical therapy.
The experimental group will be given a free pelvic floor muscle exercise application while the control group will be provided with the paper-based standard of care for their home exercise program.
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 (Participant)
盲法说明
Participants were blinded to their group allocation and were not aware that another treatment existed until debriefing and unblinding.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-85 years old
- •Referred to outpatient pelvic floor physical therapy for treatment of pelvic floor weakness
- •Generation 5 or later iPhone, Android, or Smart Device
- •Must be willing to receive Push Notification reminders from the application
- •Must have free space on device to download and install app
- •Must have access to the Google Play store or to iOS Apple App Store
排除标准
- •● Not Meeting Inclusion Criteria
- •Pelvic Organ Prolapse Surgery with complications
- •Neurodegenerative Disease
- •History of TBI or CVA with resulting impairment in long- or short-term memory
- •Denervation injury to the pelvic floor
- •Spinal cord injury
- •Pelvic Pain Condition
- •Incapable of Completing Outcomes Questionnaire without caregiver support
- •Unable to speak and read English
- •Current Pregnancy
- •Less than 6 weeks postpartum
- •Researcher judgement
结局指标
主要结局
Pelvic Floor Distress Inventory short-form 20 (PFDI-20)
时间窗: From date of randomization through study completion, an average of 3 months.
Patient-reported health-related quality of life outcome measures that are widely used for assessment of pelvic floor dysfunction. The minimum score is 0, and the maximum score is 300. HIgher scores indicate higher levels of dysfunction and mean a worse outcome, lower levels indicate less dysfunction and a better outcome.
次要结局
未报告次要终点
研究者
Sarah Walker
Graduate Student enrolled in PhD in Physical Therapy program
University of Central Arkansas