Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 21 - 84 |
| Updated: | 5/5/2014 |
| Start Date: | November 2011 |
| End Date: | February 2013 |
| Contact: | Karen L Atkins, PhD, PT |
| Email: | atkins.balancesense@gmail.com |
| Phone: | (407) 625 9680 |
Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment
Multimodal Device (SEMD) when applied in conjunction with conventional 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 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 MFIM-Motor. These measurements were devised for this
study, and will be evaluated for informational purposes only.
Multimodal Device (SEMD) when applied in conjunction with conventional 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 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 MFIM-Motor. These measurements were devised for this
study, and will be evaluated for informational purposes only.
This study will compare two approaches of physical therapy intervention within vestibular
deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. conventional
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 will include a maximum of 12 physical therapy intervention sessions, 2
times per week for 6 weeks or normalization of SOT, whichever occurs first. Conventional
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.
deficit populations that frequently fall: 1. physical therapy plus SEMD, and 2. conventional
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 will include a maximum of 12 physical therapy intervention sessions, 2
times per week for 6 weeks or normalization of SOT, whichever occurs first. Conventional
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.
Inclusion Criteria:
1. Self-reporting 2 or more falls with or without injury within the past 6 months.
2. Below normal SOT containing a abnormal vestibular score.
3. Potential to benefit from physical therapy as indicated by physician prescription
referral.
4. Able to sit and to stand unaided for 2 minutes.
5. Willing and able to complete all testing, training, and follow-up evaluations
required by the study protocol.
Exclusion Criteria:
1. Fluctuating Meniere's
2. Vestibular injury requiring surgery such as perilymph fistula
3. Moderate progressive neurologic disease such as multiple sclerosis
4. Does not speak and understand the English language
5. Resides in a nursing home
6. Unable to provide own consent.
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