Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).
研究概览
简要总结
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who fall as a result of vestibular inducted disequilibrium.
Study participants will receive regular physical therapy, and some will use the SEMD device while receiving usual care vestibular-balance physical therapy. The device is an elastic belt that holds eight small battery powered vibrating disks. When using the device, you will sit or stand on a force platform that measures body sway. That movement information is sent to a computer which then sends the information to you via the vibrating disks. The vibrating disks are similar to a vibrating cell phone: you can feel the vibration but it is not uncomfortable. You can also see your sway movement on the computer screen. Some tests and activities will be paced with a beeping sound.
The aim of this study is six-fold: 1. Demonstrate the relative efficiency between SEMD and conventional vestibular-balance physical therapy as reported by treating physical therapists' by counting number of skills acquired in a treatment session, and the amount of time needed to acquire the skill; 2. Demonstrate greater improvement earlier on in balance test scores when using the SEMD as an adjunct to conventional vestibular-balance physical therapy; 3. Determine the difference in vestibular habituation between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 4. Demonstrate a more immediate reduction in fall occurrence when using SEMD as an adjunct to conventional vestibular-balance physical therapy; 5. Determine the patient's perception of quality of life between physical therapy plus SEMD and conventional vestibular-balance physical therapy; 6. Determine difference in acquisition of large movement tasks of tandem walk, step quick-turn, and kneel-shoulder rifle-return to stand between subjects that have trained with SEMD and conventional vestibular-balance physical therapy .
In addition to primary and secondary outcome measurements, efficiency of skill acquisition, devised for this study, will be evaluated by tracking the number of skills and length of time needed to acquire each skill for each physical therapy session using the Patient Skill Acquisition Chart (PSAC). Usefulness of Tandem Walk, Step Quick-turn, and Kneel- Shoulder Rifle-Return to Stand as intervention outcome, also devised for this study, will be evaluated with pre test to post tests Modified Functional Independence Measure - Motor (MFIM-Motor). These measurements were devised for this study, and will be evaluated for informational purposes only.
详细描述
This study will compare two approaches of physical therapy intervention within vestibular deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. usual care physical therapy only.
Multimodal sensory cueing gives additional or enriched information to complement postural and mobility decisions. SEMD displays combine vibrotactile, visual and audio cueing that are intuitive and non-intrusive within a balance training system.
Study intervention includes a maximum of 12 physical therapy intervention sessions, 2 times per week for 6 weeks or normalization of SOT, whichever occurs first. Usual care physical therapy prescriptions are written specific for number of sessions over a specific duration of time. Discharge from physical therapy occurs when number of sessions within a specified period of time is exhausted or goals specified by the physical therapist are met. Data collection includes 1 pre test and 4 post tests at intervals during the weeks of intervention, plus 3 follow-up phone interviews at specified intervals after intervention for maximal study duration of 6 months. A patient must attend at least 4 physical therapy intervention sessions for their data to be used and for the follow-up phone interviews to be initiated.
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
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reporting 2 or more falls with or without injury within the past 6 months.
- •Below normal SOT containing a abnormal vestibular score.
- •Potential to benefit from physical therapy as indicated by physician prescription referral.
- •Able to sit and to stand unaided for 2 minutes.
- •Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
排除标准
- •Fluctuating Meniere's
- •Vestibular injury requiring surgery such as perilymph fistula
- •Moderate progressive neurologic disease such as multiple sclerosis
- •Does not speak and understand the English language
- •Resides in a nursing home
- •Unable to provide own consent.
结局指标
主要结局
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).
时间窗: Pre Test to Post Test 1 after two physical therapy sessions (one week)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).
时间窗: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).
时间窗: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).
时间窗: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)
Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.
次要结局
- Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2(Pre Test to Post Test 2 after four physical therapy sessions within 10 days)
- Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1(Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days)
- Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2(Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.)
- Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4(Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days)
- Head Shake Sensory Organization Test (HS_SOT)(Pre Test, Post Test 1 and Post Test 4)
研究者
Karen L Atkins
Study Director
BalanceSense LLC