Trial Outcomes & Findings for "Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?" (NCT NCT03403400)

NCT ID: NCT03403400

Last Updated: 2020-07-02

Results Overview

The mCTSIB quantifies the ability of the patient to use information from somatosensory, visual and vestibular system effectively for postural stability. This test eliminated conditions 3 and 6 of the original CTSIB, which use an altered visual input (visual conflict dome). It is performed with the feet together, a modification from the original test, which is with feet apart.(7) The four conditions of mCTSIB are standing on firm surface eyes open, standing on firm surface eyes closed, standing on compliant surface eyes open, and standing on compliant surface eyes closed. The patient is timed for 30 seconds and the average score of three trials is obtained. It only requires a timer and balance foam to administer the test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Change from up to week 9 of treatment to up to 16 weeks of treatment

Results posted on

2020-07-02

Participant Flow

The participants were recruited from July 2018 - September 2019 through consecutive admissions from two outpatient clinics with therapists with experience in VR.

After the subject signed the informed consent, the study coordinator was notified by the research staff to conduct a retrospective chart review of the medical record of the subject. Based on the retrospective chart review, the study coordinator determined if the subject was eligible to participate in the study.

Participant milestones

Participant milestones
Measure
VRWP Group
Vestibular Rehabilitation plus Walking with Pedometer Groupd VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily.
VRW Group
Vestibular Rehabilitation plus Walking without Pedometer Group VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VR Group
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
Overall Study
STARTED
5
6
6
Overall Study
COMPLETED
3
6
4
Overall Study
NOT COMPLETED
2
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
VRWP Group
Vestibular Rehabilitation plus Walking with Pedometer Groupd VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily.
VRW Group
Vestibular Rehabilitation plus Walking without Pedometer Group VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VR Group
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
Overall Study
Lost to Follow-up
1
0
1
Overall Study
Hospitalization
1
0
0
Overall Study
Benign Paroxysmal Positional Vertigo
0
0
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
VRWP Group
n=3 Participants
Vestibular Rehabilitation plus Walking with Pedometer Groupd VRWP Group: The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily.
VRW Group
n=6 Participants
Vestibular Rehabilitation plus Walking without Pedometer Group VRW Group: The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VR Group
n=4 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
Total
n=13 Participants
Total of all reporting groups
Age, Continuous
77.67 years
STANDARD_DEVIATION 10.41 • n=3 Participants
81.17 years
STANDARD_DEVIATION 9.81 • n=6 Participants
78.25 years
STANDARD_DEVIATION 8.81 • n=4 Participants
79.03 years
STANDARD_DEVIATION 9.68 • n=13 Participants
Sex: Female, Male
Female
2 Participants
n=3 Participants
2 Participants
n=6 Participants
2 Participants
n=4 Participants
6 Participants
n=13 Participants
Sex: Female, Male
Male
1 Participants
n=3 Participants
4 Participants
n=6 Participants
2 Participants
n=4 Participants
7 Participants
n=13 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
IPAQ-Walk
660 METS-min/week
STANDARD_DEVIATION 646.03 • n=3 Participants
562.07 METS-min/week
STANDARD_DEVIATION 212.10 • n=6 Participants
2293.5 METS-min/week
STANDARD_DEVIATION 4020.56 • n=4 Participants
1171.86 METS-min/week
STANDARD_DEVIATION 1626.23 • n=13 Participants
IPAQ-Total
1046.67 METS-min/week
STANDARD_DEVIATION 805.75 • n=3 Participants
2145.4 METS-min/week
STANDARD_DEVIATION 2667.75 • n=6 Participants
3963.5 METS-min/week
STANDARD_DEVIATION 6573.74 • n=4 Participants
2385.19 METS-min/week
STANDARD_DEVIATION 3349.08 • n=13 Participants

PRIMARY outcome

Timeframe: Change from up to week 9 of treatment to up to 16 weeks of treatment

Population: Pretest and posttest means of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10)

The mCTSIB quantifies the ability of the patient to use information from somatosensory, visual and vestibular system effectively for postural stability. This test eliminated conditions 3 and 6 of the original CTSIB, which use an altered visual input (visual conflict dome). It is performed with the feet together, a modification from the original test, which is with feet apart.(7) The four conditions of mCTSIB are standing on firm surface eyes open, standing on firm surface eyes closed, standing on compliant surface eyes open, and standing on compliant surface eyes closed. The patient is timed for 30 seconds and the average score of three trials is obtained. It only requires a timer and balance foam to administer the test.

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Modified Clinical Test of Sensory Integration for Balance (mCTSIB)
Pretest
115.98 seconds
Standard Deviation 5.82
97.4 seconds
Standard Deviation 5.78
110.15 seconds
Standard Deviation 9.97
107.23 seconds
Standard Deviation 10.55
Modified Clinical Test of Sensory Integration for Balance (mCTSIB)
Posttest
120 seconds
Standard Deviation 0
111.17 seconds
Standard Deviation 10.234
118 seconds
Standard Deviation 3.35
115.27 seconds
Standard Deviation 7.23

PRIMARY outcome

Timeframe: Change from up to week 9 of treatment to up to 16 weeks of treatment

Population: Pretest and posttest means of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10).

The TUG is a test of balance and risk for falls.(8) This test measures the time it takes to walk 3 meters starting from a sitting position and it ends when the patient is seated again. Among the population studied for the TUG are the frail elderly and vestibular disorders.(9) The cut-off scores that indicate risk for falls are greater than 13.5 seconds for community dwelling older adults (8) and greater than 11.1 seconds for vestibular disorders.(10)

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Timed Up and Go (TUG) Test
Posttest
7.80 seconds
Standard Deviation 1.3
10 seconds
Standard Deviation 3.46
10.92 seconds
Standard Deviation 5.12
10.55 seconds
Standard Deviation 4.34
Timed Up and Go (TUG) Test
Pretest
10 seconds
Standard Deviation 1.64
12.73 seconds
Standard Deviation 3.54
12.42 seconds
Standard Deviation 5.75
12.54 seconds
Standard Deviation 4.75

PRIMARY outcome

Timeframe: Change from up to week 9 of treatment to up to 16 weeks of treatment

Population: Pretest and posttest means of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10)

The DGI assesses the ability to maintain balance while walking in the presence of external demands. It is scored based on a 4-point ordinal scale (3=no gait dysfunction, 2=minimal impairment, 1=moderate impairment and 0=severe impairment) with the highest possible score of 24.(11) A cut-off score of less than 19 is indicative of increased fall risks in community-dwelling elderlies.(12)

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Dynamic Gait Index
Pretest
20 score
Standard Deviation 2.74
19.5 score
Standard Deviation 2.38
20.67 score
Standard Deviation 2.88
20.2 score
Standard Deviation 2.62
Dynamic Gait Index
Posttest
22.80 score
Standard Deviation 1.64
22 score
Standard Deviation 1.63
22.67 score
Standard Deviation 1.03
22.4 score
Standard Deviation 1.26

PRIMARY outcome

Timeframe: Change from up to week 9 of treatment to up to 16 weeks of treatment

Population: Pretest and posttest means of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10)

The DHI is a 25-item self-report questionnaire that quantifies the functional, emotional and physical impact of dizziness. Answers are graded 0 for no, 2 for sometimes and 4 for yes, with a maximum total score of 100. Interpretations are mild dizziness for scores between 0-30, moderate for 31-60 and severe for 61-100.(13)

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Dizziness Handicap Inventory (DHI)
Posttest
13.2 score
Standard Deviation 18.9
11.5 score
Standard Deviation 9.71
7.33 score
Standard Deviation 5.16
9 score
Standard Deviation 7.13
Dizziness Handicap Inventory (DHI)
Pretest
16 score
Standard Deviation 22.56
38.5 score
Standard Deviation 31.09
23.67 score
Standard Deviation 13.65
29.6 score
Standard Deviation 22.01

SECONDARY outcome

Timeframe: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment

Population: There are 5 participants in the Control (Vestibular Rehabilitation) Group and 10 Walking Group. Participants in the Walking Group received a prescribed walking program in the form of pedometer (Vestibular Rehabilitation plus walking with pedometer or VRWP N=4 and timed-walking (Vestibular Rehabilitation plus walking without Pedometer or VRW N=6).

The total number of visits after signing the informed consent between the three intervention groups were compared.

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Total Number of Visits
5.6 visits
Standard Deviation 1.03
6.75 visits
Standard Deviation 1.89
7.33 visits
Standard Deviation 1.89
7.04 visits
Standard Deviation 1.89

SECONDARY outcome

Timeframe: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment

Population: Means and Standard Deviations of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10)

The length of interventions in weeks between the three intervention group will be compared.

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=5 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
n=10 Participants
VRWP and VRW data were combined into a group representing prescribed walking.
Length of Interventions in Weeks
8.5 weeks
Standard Deviation 1.41
9.25 weeks
Standard Deviation 1.65
8.5 weeks
Standard Deviation 1.98
8.88 weeks
Standard Deviation 1.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from up to week 9 of treatment to up to 4 weeks post treatment

Population: IPAQ-Walk scores were categorized as increase if there was an increase in four-weeks follow-up score compared to pretest score, same if there was no change in four-weeks follow-up score compared to pretest score, and decrease if there was a decline in four-weeks follow-up score compared to pretest score.

The IPAQ short form is an instrument evaluation tool of physical activity among the adults. It has three categories: low, moderate and high. The specific type of activities assessed are walking, moderate intensity activities and vigorous intensity activities. All continuous scores are expressed in MET-minutes/week with walking =3.3 METs, Moderate PA=4.0 METs and Vigorous PA = 8.0 METs. An overall total physical activity score can be computed as the sum of the total MET-minutes/week scores.(14)

Outcome measures

Outcome measures
Measure
Control (VR) Group
n=3 Participants
Vestibular Rehabilitation Only Group. The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
VRWP (Vestibular Rehabilitation With Walking With Pedometer)
n=6 Participants
Vestibular Rehabilitation with Walking with Pedometer. The VRWP group (N=4) had VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group).
VRW (Vestibular Rehabilitation Walking Without a Pedometer)
n=4 Participants
Vestibular Rehabilitation with Walking without a Pedometer. The VRW group (N=6) received VR and a time-based instruction to walk more daily at least 10 minutes at a time (VR plus walking no pedometer group).
Prescribed Walking Group
VRWP and VRW data were combined into a group representing prescribed walking.
International Physical Activity Questionnaire (IPAQ)- Walk
decrease
0 participants
2 participants
2 participants
International Physical Activity Questionnaire (IPAQ)- Walk
increase
3 participants
4 participants
2 participants
International Physical Activity Questionnaire (IPAQ)- Walk
same
0 participants
0 participants
0 participants

Adverse Events

VRWP Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

VRW Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

VR Group

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

Amie Jasper

Advent Health

Phone: 407-303-8626

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place