Trial record 6 of 602 for:    "Ear Diseases"

Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by BalanceSense LLC.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Karen L Atkins, BalanceSense LLC
ClinicalTrials.gov Identifier:
NCT01483937
First received: November 30, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Traumatic Brain Injury
Device: Usual care physical therapy plus SEMD
Other: Conventional physical therapy only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium

Resource links provided by NLM:


Further study details as provided by BalanceSense LLC:

Primary Outcome Measures:
  • Sensory Organization Test (SOT) [ Time Frame: Pre Test to Post Test 1 after two physical therapy sessions (one week) ] [ Designated as safety issue: No ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 1 Sensory Organization Test (SOT.)

  • Sensory Organization Test (SOT) [ Time Frame: Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks) ] [ Designated as safety issue: No ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 2, and post test 1 to post test 2 Sensory Organization Test (SOT.)

  • Sensory Organization Test (SOT) [ Time Frame: Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks) ] [ Designated as safety issue: No ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 3, and post test 2 to post test 3 Sensory Organization Test (SOT.)

  • Sensory Organization Test (SOT) [ Time Frame: Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks) ] [ Designated as safety issue: No ]
    Assessment of the efficacy of the SEMD device in improving vestibular function will be evaluated with pre test to post test 4, and post test 3 to post test 4 Sensory Organization Test (SOT.)


Secondary Outcome Measures:
  • Functional Gait Assessment [ Time Frame: Pre Test, Post Test 1 after two physical therapy sessions, Post Test 2 after four physical therapy sessions, Post Test 3 after eight physical therapy sessions, and Post Test 4 after twelve physical therapy sessions ] [ Designated as safety issue: No ]
    Measurements of transfer of skill(s) to activities of daily living.

  • Self-report Fall(s) Occurrence and Duty/Work Status [ Time Frame: Pre Test, Post Tests 1-5 as above, Phone Follow-up 1 two weeks post intervention, Phone Follow-up 2 eight weeks post intervention, Phone Follow-up 3 eighteen weeks post intervention ] [ Designated as safety issue: No ]
    Skill retention will be evaluated pre intervention to post intervention with a questionnaire devised for this study.

  • Berg Balance Scale [ Time Frame: Pre Test, Post Test 2, Post Test 4 ] [ Designated as safety issue: No ]
    Measurement of transfer of skills to activities of daily living.

  • Vestibular Rehabilitation Benefit Questionnaire [ Time Frame: Pre Test, Post Test 4 ] [ Designated as safety issue: No ]
    Self rated measurement of perceived quality of life.

  • Head Shake Sensory Organization Test (HS_SOT) [ Time Frame: Pre Test, Post Test 1 and Post Test 4 ] [ Designated as safety issue: No ]
    Secondary outcome measurement of vestibular function.


Estimated Enrollment: 192
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional care physical therapy only
Subjects will receive usual physical therapy intervention provided by vestibular and balance specialists.
Other: Conventional physical therapy only
Subjects will receive standard care physical therapy from vestibular and balance specialists.
Experimental: Conventional physical therapy plus SEMD
Subjects will receive usual physical therapy intervention while using SEMD: SEMD protocols will augment conventional physical therapy.
Device: Usual care physical therapy plus SEMD
Patients will receive standard care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483937

Contacts
Contact: Karen L Atkins, PhD, PT (407) 625 9680 atkins.balancesense@gmail.com

Locations
United States, California
England Physical Therapy Recruiting
Garden Grove, California, United States, 92840
Contact: Teresa England, MPT, PT    714-703-8477    teresapt@msn.com   
Sub-Investigator: Teresa England, MPT, PT         
United States, Florida
Florida Ear & Balance Center Recruiting
Celebration, Florida, United States, 34747
Contact: Karen L Atkins, PhD, PT    407-625-9680    atkins.balancesense@gmail.com   
Contact: Michelle Simmons    (321) 939-3000    flear@atlantic.net   
Principal Investigator: Karen L Atkins, PhD, PT         
Stevenson & Associates Physical Therapy Recruiting
Fort Myers, Florida, United States, 33908
Contact: Eric Stevenson, PT    239-454-6262    stevensonpt@earthlink.net   
Contact: Jessica Bishop    (239) 454-6262      
Sub-Investigator: Eric Stevenson, PT         
Brooks Balance Center Recruiting
Jacksonville, Florida, United States, 32216
Contact: Ann Leinenwever, PT    904-854-2050      
Contact: Holly Morris    (904) 345-8970    Holly.Morris@brooksrehab.org   
Principal Investigator: Karen L Atkins, PhD, PT         
Sponsors and Collaborators
Karen L Atkins
Investigators
Study Director: Karen L Atkins, PhD, PT BalanceSense LLC
  More Information

No publications provided

Responsible Party: Karen L Atkins, Study Director, BalanceSense LLC
ClinicalTrials.gov Identifier: NCT01483937     History of Changes
Other Study ID Numbers: 10-221:1.2, W81XWH-10-C-0184-01
Study First Received: November 30, 2011
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by BalanceSense LLC:
Keywords provided by BalanceSense, LLC:
Physical Therapy
Rehabilitation
Disequilibrium
Balance dysfunction or disorder
Vestibular
Mild Traumatic Brain Injury or mTBI

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Otorhinolaryngologic Diseases
Vestibular Diseases
Brain Injuries
Mental Retardation
Wounds and Injuries
Otitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014