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| ID | Type | Description | Link |
|---|---|---|---|
| A534255 | Other Identifier | UW, Madison | |
| SMPH/MEDICINE/GER-AD DEV | Other Identifier | UW, Madison |
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The overall purpose of this multi-phase study is to develop (Phase 1) and test potential effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls prevention maintenance program for Stepping On (SO) graduates in a group randomized trial (Phase 2).
This application refers to effectiveness component of Phase 2, which entails the randomized clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail process evaluation of the Stepping Online intervention group only.
Aim:
This application, for Phase 2 of a larger study, is a 6-month group randomized trial to test the effectiveness of Stepping Online.
Stepping Online (developed in Phase 1) is a continuation website to help Stepping On graduates to:
Approach:
Subject Eligibility:
Recruitment and Consenting:
Randomization
Randomization will occur on the Stepping On workshop level to ensure that leaders, peer leaders and participants are in the same arm. Procedures:
Participants in both study arms will complete measurements at their workshop location or another location that is private and convenient fir subjects at baseline (prior to randomization), and later at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepping Online | Active Comparator | Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.
|
|
| Stepping On Usual Care Control | No Intervention | Subjects control workshops in the condition will not have access to Stepping Online. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepping Online | Behavioral | Stepping Online is a password-protected website with Stepping On graduates, whose groups are randomized to Stepping Online and will have access to and training in a password-protected website. The website includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Number of Falls From Baseline to 6 Months | Number of Falls: monthly calendar self-administered sent and returned via mail | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Tandem Walk Errors at 3 Months and 6 Months | Observed via the Tandem Walk Test at baseline, 3 months, 6 months. Tandem walk errors were the number of errors while walking a four-meter straight line. Place a line on the floor marking the distance. The heel of one foot should be touching the tip of the toes of the other foot. Count the number of errors (stepping off the straight line, not putting heel to toe, needing to grab for support, significant body lean). Participants can use an assistive device if they normally use one. |
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List of Inclusion Criteria:
In Milwaukee and Dane counties, extra effort will be made to enroll African American Stepping On participants/graduates, who are more likely to have lower income and educational level and to be uninsured than their White counterparts.
List of Exclusion Criteria:
Leaders/Peer Leaders:
Stepping On Participants/Graduates:
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| Name | Affiliation | Role |
|---|---|---|
| Jane E Mahoney, MD | University of Wisconsin, Madison | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22872695 | Background | Clemson L, Fiatarone Singh MA, Bundy A, Cumming RG, Manollaras K, O'Loughlin P, Black D. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ. 2012 Aug 7;345:e4547. doi: 10.1136/bmj.e4547. | |
| 8126356 | Background |
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Of the total 157 invitees, 45 enrolled; 112 did not. Of the 112 non-joiners, 53 declined further contact; 16 were not reached; 12 were ineligible, 31 refused.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepping Online | Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes:
|
| FG001 | Stepping On Usual Care Control | Control Stepping On graduates did not have access to Stepping Online. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepping Online | Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors. |
| BG001 | Stepping On 'Usual Care' |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Number of Falls From Baseline to 6 Months | Number of Falls: monthly calendar self-administered sent and returned via mail | Posted | Mean | Standard Deviation | falls | baseline and 6 months |
|
up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepping Online | Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes:
|
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Limitations include the small sample size. With multiple tests/measures significance might have been by chance. Bonferroni corrections were not performed. Fewer than 30% of the SO graduates who were invited enrolled in the study; these results may not be generalizable to all SO graduates. Lack of access to and comfort with online devices were barriers for some refusers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Research Specialist | University of Wisconsin-Madison | 6082631105 | wpalmer3@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2016 | Jun 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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|
|
| up to 6 months |
| Gait Speed at 3 Months and 6 Months | Observed at baseline, 3 months, 6 months; measured in meters per second over four meters. | up to 6 months |
| Short Physical Performance Battery (SPPB): Total Balance Test | Standing feet together (side by side) for 10 seconds, followed by standing with side of one heel touching the big toe of the other foot (semi-tandem) for 10 seconds, followed by standing with the heel of one foot in front of the toes of the other (tandem) for 10 seconds. Participants are scored either 0 or 1 for each balance exercise with a total possible range from 0-3 where higher scores indicate improved balance. | up to 6 months |
| Short Physical Performance Battery (SPPB): Gait Speed Test | Participant is timed while walking an 8 foot line on the floor. Scoring is as follows: 0 = could not do
| 6 months |
| Short Physical Performance Battery (SPPB): Chair Stand Test | Participant is timed while attempting to stand up and sit down 5 times from a chair without using their arms. Scoring is as follows: 0 = unable
| up to 6 months |
| Short Physical Performance Battery (SPPB): Summary Score | The total possible range of scores for the SPPB repeated chair test, gait test, and balance test is 0-12 where higher scores indicate the best performance. | up to 6 months |
| Falls Behavioral Risk Scale (FaB) | The Falls Behavioral Scale is a list of 24 statements that describe things participants do in everyday life. Participants are to circle 'never', 'sometimes', 'often', 'always' or 'doesn't apply'. Scoring is from 1 (never) to 4 (always) and is reported as the average score where higher scores indicate higher mitigation of fall risk. | up to 6 months |
| Revised UCLA Loneliness Scale (R-UCLA) | A 3-item scale (adapted, short form of the full 20-item scale) designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 3-point Likert scale is used that ask participants to rate each item as either 3 - "I often feel this way", 2 - "I sometimes feel this way", or 1 - "I hardly ever feel this way". Scoring: Items 1-3 are summed and participants are given a composite score of 3-9, with higher scores indicating a greater sense of loneliness. | up to 6 months |
| T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument | The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GMH is 21.2 - 67.6 where higher scores indicate better quality of life. | up to 6 months |
| T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument | The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GPH is 16.2 - 67.7 where higher scores indicate better quality of life. | up to 6 months |
| Physical Activity Barriers Self-Efficacy Score | Self-efficacy to reduce barriers to exercise was measured using a 16-item survey where participants rate their confidence that they could perform falls prevention exercises every day for the next 3 months under various circumstances, from 0% 'not at all confident' to 100% 'very confident'. Scores will be reported from 0-10 with higher scores indicated increased self-efficacy. | up to 6 months |
| Global Rating of Change Score at 6 Months | Measures self-perceived change in balance, quantifying the extent to which a participant's balance has improved or deteriorated in the over time (past 6 months). A single question asks the participant to rate their change in balance inside their house, and a single question asks patients to rate their change in balance outside of their house. A Likert scare of -7 ("a very great deal worse") to +7 ("a very great deal better") is used to rate this perceived change. | 6 months |
| Balance Exercise Adherence at 3 and 6 Months | Adherence was assessed at 3 and 6 months as the number of days balance exercises were performed each week. | up to 6 months |
| Strength Exercise Adherence at 3 and 6 Months | Adherence was assessed at 3 and 6 months as the number of days strength exercises were performed each week. | up to 6 months |
| Social Bonding Score at 3 Months and 6 Months | Socialization included the 5-item Social Bonding Scale at all timepoints measured as the summed score on a Likert scale of 0 (not at all) to 4 (very much), range 0-20. | up to 6 months |
| Encouragement to do Exercises Score at 3 Months and 6 Months | Socialization included the feeling Encouraged to Exercise at 3 and 6 months on 1 (very difficult) to 5 (very easy) scale. | up to 6 months |
| Activities Balance Confidence (ABC) Scale at 3 and 6 Months | The ABC instrument measures the confidence of participants from 0% (no confidence) to 100% (completely confident) for activity in a range of conditions. Scoring is from 0-10 where higher numbers are more confidence. | up to 6 months |
| Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85. |
| 18504506 | Background | Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574. |
| 19543809 | Background | Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. |
| 21804645 | Background | Gustafson DH, Hawkins R, McTavish F, Pingree S, Chen WC, Volrathongchai K, Stengle W, Stewart JA, Serlin RC. Internet-Based Interactive Support for Cancer Patients: Are Integrated Systems Better? J Commun. 2008 Jun;58(2):238-257. doi: 10.1111/j.1460-2466.2008.00383.x. |
| 15341550 | Background | Clemson L, Cumming RG, Kendig H, Swann M, Heard R, Taylor K. The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial. J Am Geriatr Soc. 2004 Sep;52(9):1487-94. doi: 10.1111/j.1532-5415.2004.52411.x. |
| Background | Mahoney, J. E., Gangnon, R., Clemson, L. M., Gobel, V. L., & Lecey, V. (2012, November). Evaluation of stepping on implementation across Wisconsin. In GERONTOLOGIST (Vol. 52, pp. 479-479). JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA: OXFORD UNIV PRESS INC. |
| 39360568 | Derived | Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2. |
Control Stepping On graduates did not have access to Stepping Online.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Days Since Last Stepping On Class | Mean | Standard Deviation | days |
|
| Number of Falls in the Past 6 months | Mean | Standard Deviation | falls |
|
| Number of Participants Who Fell At Least 1 in the last 6 months | Count of Participants | Participants |
|
| Number of Participants With College Education | Count of Participants | Participants |
|
| Number of Married Participants | Count of Participants | Participants |
|
| Number of Participants in a City/Suburb | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Tandem Walk Errors at 3 Months and 6 Months | Observed via the Tandem Walk Test at baseline, 3 months, 6 months. Tandem walk errors were the number of errors while walking a four-meter straight line. Place a line on the floor marking the distance. The heel of one foot should be touching the tip of the toes of the other foot. Count the number of errors (stepping off the straight line, not putting heel to toe, needing to grab for support, significant body lean). Participants can use an assistive device if they normally use one. | Not all participants completed the study. | Posted | Mean | Standard Deviation | errors | up to 6 months |
|
|
|
|
| Secondary | Gait Speed at 3 Months and 6 Months | Observed at baseline, 3 months, 6 months; measured in meters per second over four meters. | Not all participants completed the study. | Posted | Mean | Standard Deviation | meters per second | up to 6 months |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB): Total Balance Test | Standing feet together (side by side) for 10 seconds, followed by standing with side of one heel touching the big toe of the other foot (semi-tandem) for 10 seconds, followed by standing with the heel of one foot in front of the toes of the other (tandem) for 10 seconds. Participants are scored either 0 or 1 for each balance exercise with a total possible range from 0-3 where higher scores indicate improved balance. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB): Gait Speed Test | Participant is timed while walking an 8 foot line on the floor. Scoring is as follows: 0 = could not do
| Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB): Chair Stand Test | Participant is timed while attempting to stand up and sit down 5 times from a chair without using their arms. Scoring is as follows: 0 = unable
| Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB): Summary Score | The total possible range of scores for the SPPB repeated chair test, gait test, and balance test is 0-12 where higher scores indicate the best performance. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Falls Behavioral Risk Scale (FaB) | The Falls Behavioral Scale is a list of 24 statements that describe things participants do in everyday life. Participants are to circle 'never', 'sometimes', 'often', 'always' or 'doesn't apply'. Scoring is from 1 (never) to 4 (always) and is reported as the average score where higher scores indicate higher mitigation of fall risk. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Revised UCLA Loneliness Scale (R-UCLA) | A 3-item scale (adapted, short form of the full 20-item scale) designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 3-point Likert scale is used that ask participants to rate each item as either 3 - "I often feel this way", 2 - "I sometimes feel this way", or 1 - "I hardly ever feel this way". Scoring: Items 1-3 are summed and participants are given a composite score of 3-9, with higher scores indicating a greater sense of loneliness. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument | The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GMH is 21.2 - 67.6 where higher scores indicate better quality of life. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument | The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GPH is 16.2 - 67.7 where higher scores indicate better quality of life. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Physical Activity Barriers Self-Efficacy Score | Self-efficacy to reduce barriers to exercise was measured using a 16-item survey where participants rate their confidence that they could perform falls prevention exercises every day for the next 3 months under various circumstances, from 0% 'not at all confident' to 100% 'very confident'. Scores will be reported from 0-10 with higher scores indicated increased self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Global Rating of Change Score at 6 Months | Measures self-perceived change in balance, quantifying the extent to which a participant's balance has improved or deteriorated in the over time (past 6 months). A single question asks the participant to rate their change in balance inside their house, and a single question asks patients to rate their change in balance outside of their house. A Likert scare of -7 ("a very great deal worse") to +7 ("a very great deal better") is used to rate this perceived change. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | Balance Exercise Adherence at 3 and 6 Months | Adherence was assessed at 3 and 6 months as the number of days balance exercises were performed each week. | Not all participants completed the study. | Posted | Mean | Standard Deviation | days per week | up to 6 months |
|
|
|
|
| Secondary | Strength Exercise Adherence at 3 and 6 Months | Adherence was assessed at 3 and 6 months as the number of days strength exercises were performed each week. | Not all participants completed the study. | Posted | Mean | Standard Deviation | days per week | up to 6 months |
|
|
|
|
| Secondary | Social Bonding Score at 3 Months and 6 Months | Socialization included the 5-item Social Bonding Scale at all timepoints measured as the summed score on a Likert scale of 0 (not at all) to 4 (very much), range 0-20. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Encouragement to do Exercises Score at 3 Months and 6 Months | Socialization included the feeling Encouraged to Exercise at 3 and 6 months on 1 (very difficult) to 5 (very easy) scale. | Not all participants completed the study. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| Secondary | Activities Balance Confidence (ABC) Scale at 3 and 6 Months | The ABC instrument measures the confidence of participants from 0% (no confidence) to 100% (completely confident) for activity in a range of conditions. Scoring is from 0-10 where higher numbers are more confidence. | Not all participants completed the study | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Stepping On Usual Care Control | Control Stepping On graduates did not have access to Stepping Online. | 0 | 22 | 0 | 22 | 0 | 22 |
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| 3 Months |
|
|
| 6 Months |
|
|
| 0.001 |
| Mean Difference (Final Values) |
| -4.07 |
| 2-Sided |
| 95 |
| -6.47 |
| -1.68 |
| Superiority |
| 3 Months |
|
|
| 6 Months |
|
|
| 0.0003 |
| Mean Difference (Final Values) |
| 0.15 |
| 2-Sided |
| 95 |
| 0.07 |
| 0.22 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.83 |
| Mean Difference (Final Values) |
| -0.05 |
| 2-Sided |
| 95 |
| -0.48 |
| 0.37 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.14 |
| Mean Difference (Final Values) |
| 0.33 |
| 2-Sided |
| 95 |
| -0.11 |
| 0.77 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.36 |
| Mean Difference (Final Values) |
| 0.27 |
| 2-Sided |
| 95 |
| -0.31 |
| 0.85 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.26 |
| Mean Difference (Final Values) |
| 0.54 |
| 2-Sided |
| 95 |
| -0.42 |
| 1.49 |
| Superiority |
| 3 month |
|
|
| 6 month |
|
|
| 0.29 |
| Mean Difference (Final Values) |
| -0.20 |
| 2-Sided |
| 95 |
| -0.55 |
| 0.17 |
| Superiority |
| 3 Months |
|
|
| 6 Months |
|
|
| 3 months |
|
|
| 6 months |
|
|
| 0.80 |
| Mean Difference (Final Values) |
| -0.33 |
| 2-Sided |
| 95 |
| -2.79 |
| 2.15 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.38 |
| Mean Difference (Final Values) |
| 1.18 |
| 2-Sided |
| 95 |
| -1.49 |
| 3.81 |
| Superiority |
| 6 months |
|
| Outside Balance |
|
|
| Strength |
|
|
| 0.05 |
| Mean Difference (Final Values) |
| 1.75 |
| 2-Sided |
| 95 |
| -0.02 |
| 3.51 |
| Superiority |
| Strength | Fisher Exact | 0.06 | Mean Difference (Final Values) | 1.86 | 2-Sided | 95 | -0.08 | 3.81 | Superiority |
| Balance Exercises at 6 Months |
|
|
| 0.11 |
| Mean Difference (Final Values) |
| 1.01 |
| 2-Sided |
| 95 |
| -0.22 |
| 2.24 |
| Superiority |
| 6 Months |
|
|
| 0.11 |
| Mean Difference (Final Values) |
| 0.75 |
| 2-Sided |
| 95 |
| -0.16 |
| 1.67 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.02 |
| Mean Difference (Final Values) |
| 2.60 |
| 2-Sided |
| 95 |
| 0.43 |
| 4.73 |
| Superiority |
| 6 months |
|
|
| 0.06 |
| Mean Difference (Final Values) |
| 0.63 |
| 2-Sided |
| 95 |
| -0.02 |
| 1.27 |
| Superiority |
| 3 months |
|
|
| 6 months |
|
|
| 0.59 |
| Mean Difference (Final Values) |
| 0.18 |
| 2-Sided |
| 95 |
| -0.45 |
| 0.81 |
| Superiority |