Trial Outcomes & Findings for Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium (NCT NCT01483937)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Pre Test to Post Test 1 after two physical therapy sessions (one week)

Results posted on

2014-06-27

Participant Flow

Recruitment continued for one year resulting in 39 subjects pre screened for inclusion in the study.

Seven subjects who had signed Informed Consent prior to inclusion/exclusion screening failed screening: thirty-two subjects participated in the physical therapy protocol.

Participant milestones

Participant milestones
Measure	Conventional Care Physical Therapy Only Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Overall Study STARTED	15	17
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Care Physical Therapy Only Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	69.44 years STANDARD_DEVIATION 10.00 • n=5 Participants	73.35 years STANDARD_DEVIATION 7.46 • n=7 Participants	71.64 years STANDARD_DEVIATION 8.70 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
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).	9.82 units on a scale Standard Deviation 10.68 • Interval -17.5 to -1.1	7.29 units on a scale Standard Deviation 9.33 • Interval -25.7 to -7.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
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).	9.36 units on a scale Standard Deviation 12.80	5.00 units on a scale Standard Deviation 8.49

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
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).	3.27 units on a scale Standard Deviation 7.94	8.86 units on a scale Standard Deviation 7.72

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
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).	5.09 units on a scale Standard Deviation 6.70	.86 units on a scale Standard Deviation 6.57

SECONDARY outcome

Timeframe: Pre Test to Post Test 2 after four physical therapy sessions within 10 days

Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling. Criterion Validity: "Authors support a cut off score of 23/30 for independent safe ambulation". Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders. 3\) 23-30 = safe ambulators

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2	20 percentage of participants 2.38	77 percentage of participants 2.01

SECONDARY outcome

Timeframe: Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days

A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1	9 percentage of participants	54 percentage of participants

SECONDARY outcome

Timeframe: Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.

Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment. Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling. Criterion Validity: "Authors support a cut off score of 45/56 for independent safe ambulation". Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded: * Sensitivity = 64% (Correctly predicts fallers) * Specificity = 90% (Correctly predicts non-fallers)

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2	43 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days

Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.

Outcome measures

Outcome measures
Measure	Conventional Care Physical Therapy Only n=11 Participants Subjects received usual physical therapy intervention provided by vestibular and balance specialists.	Conventional Physical Therapy Plus SEMD n=14 Participants Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 Pre Test	39.14 units on a scale Standard Deviation 17.95	34.30 units on a scale Standard Deviation 6.52
Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4 Post Test 4	31.27 units on a scale Standard Deviation 8.25	28.32 units on a scale Standard Deviation 11.10

SECONDARY outcome

Timeframe: Pre Test, Post Test 1 and Post Test 4

Head Shake Sensory Organization Test (HS-SOT) HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis.

Outcome measures

Outcome data not reported

Adverse Events

Conventional Care Physical Therapy Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Physical Therapy Plus SEMD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen L. Atkins PhD PT

BalanceSense LLC

Phone: 407 625 9680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place