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The purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.
The process (steps) will be divided as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Daily use of the intervention Flexible footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25. |
|
| Control Group | No Intervention | During the intervention period, patients from the Control Group (CG) were instructed not to wear Flexible footwear (Moleca®) or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible footwear | Other | The patients of the Intervention Group (IG) will be use over 6 month a flexible and non-heeled footwear (Moleca; Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a women's flexible flat walking shoe, without heels, with an anti-slip rubber sole, 5-mm thin, with a 3 mm internal wedge of ethylene vinyl acetate, made out of dubbed canvas. It had a mean weight of 172 ± 19.6 g, ranging from 142 to 193 g depending upon the size. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities (WOMAC) Pain Subscale | The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Stiffness Subscale | The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel CN Sacco, PhD | Department of Physical therapy, Speech, and Occupational Therapy, School of Medicine, University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo General Hospital | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32635999 | Derived | Trombini-Souza F, Fuller R, Goldenstein-Schainberg C, Sacco ICN. Long-term use of minimal footwear in older adult women with knee osteoarthritis: Mechanisms of action in the knee adduction moment. J Biomech. 2020 Jul 17;108:109885. doi: 10.1016/j.jbiomech.2020.109885. Epub 2020 Jun 13. | |
| 26307181 | Derived | Trombini-Souza F, Matias AB, Yokota M, Butugan MK, Goldenstein-Schainberg C, Fuller R, Sacco IC. Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial. Clin Biomech (Bristol). 2015 Dec;30(10):1194-201. doi: 10.1016/j.clinbiomech.2015.08.004. Epub 2015 Aug 14. |
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The participants were recruited from the primary care centre of the School of Medicine, University of São Paulo Hospital, and rheumatology ambulatory medical. Participants were recruited between March 2011 and December 2012, and allocated equally into one of two groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25. |
| FG001 | Control Group | During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Tests t were used to provide similar characteristics between the both groups for the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25. |
| 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 | Western Ontario and McMaster Universities (WOMAC) Pain Subscale | The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain. | An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland). | Posted | Mean | Standard Deviation | score | 6 month |
|
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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 | Intervention Group | Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women's double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratosis on metatarsal head | Musculoskeletal and connective tissue disorders | Keratosis on the head of the fifth metatarsal in left foot . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francis Trombini-Souza | University of Sao Paulo | 55 11 3091 8426 | trombinisouza@usp.br |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 6 month |
| WOMAC Physical Function Subscale | The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations. | 6 month |
| WOMAC Total Score | The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition. | 6 month |
| Global Score of the Lequesne´s Questionaire Algo-functional. | This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively. | 6 month |
| Six-minute Walk Test | The six-minute walk test assesses distance in meters walked over 6 minutes. | 6 month |
| First Peak of the Knee Adduction Moment (KAM) During Gait. | The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure. | 6 month |
| Paracetamol Intake | Paracetamol intake (500 mg), number of tablets per month. | 6 month |
| 22788574 | Derived | Trombini-Souza F, Fuller R, Matias A, Yokota M, Butugan M, Goldenstein-Schainberg C, Sacco IC. Effectiveness of a long-term use of a minimalist footwear versus habitual shoe on pain, function and mechanical loads in knee osteoarthritis: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Jul 12;13:121. doi: 10.1186/1471-2474-13-121. |
| BG001 | Control Group | During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Group |
WOMAC pain subscale |
|
|
|
| Secondary | WOMAC Stiffness Subscale | The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function. | Posted | Mean | Standard Deviation | score | 6 month |
|
|
|
|
| Secondary | WOMAC Physical Function Subscale | The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations. | Posted | Mean | Standard Deviation | score | 6 month |
|
|
|
|
| Secondary | WOMAC Total Score | The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition. | Posted | Mean | Standard Deviation | score | 6 month |
|
|
|
|
| Secondary | Global Score of the Lequesne´s Questionaire Algo-functional. | This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively. | Posted | Mean | Standard Deviation | score | 6 month |
|
|
|
|
| Secondary | Six-minute Walk Test | The six-minute walk test assesses distance in meters walked over 6 minutes. | Posted | Mean | Standard Deviation | meter | 6 month |
|
|
|
|
| Secondary | First Peak of the Knee Adduction Moment (KAM) During Gait. | The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure. | Posted | Mean | Standard Deviation | % body weight x height in centimeters | 6 month |
|
|
|
|
| Secondary | Paracetamol Intake | Paracetamol intake (500 mg), number of tablets per month. | Posted | Median | Inter-Quartile Range | tablets per month | 6 month |
|
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Control Group | During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost. | 0 | 28 | 0 | 28 |
|
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| D012216 |
| Rheumatic Diseases |
| WOMAC Stiffness subscale (6th month) |
|
From baseline to 3rd month. |
| post hoc Newman-Keuls |
| <0.001 |
| Effect size |
| 0.66 |
| 2-Sided |
| No |
| Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.70 | 2-Sided | No | Superiority or Other |
| From baseline to 3rd month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.25 | 2-Sided | No | Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.16 | 2-Sided | No | Superiority or Other |
| WOMAC Physical function subscale (6 month) |
|
From baseline to 3rd month. |
| post hoc Newman-Keuls |
| <0.001 |
| Effect size |
| 1.28 |
| 2-Sided |
| No |
| Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 1.58 | 2-Sided | No | Superiority or Other |
| From baseline to 3rd month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.68 | 2-Sided | No | Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.42 | 2-Sided | No | Superiority or Other |
| WOMAC total score (6th month) |
|
From baseline to 3rd month. |
| post hoc Newman-Keuls |
| <0.001 |
| Effect size |
| 1.45 |
| 2-Sided |
| No |
| Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | 0.019 | Effect size | 1.69 | 2-Sided | No | Superiority or Other |
| From baseline to 3rd month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.66 | 2-Sided | No | Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.44 | 2-Sided | No | Superiority or Other |
| Lequesne (6th month) |
|
From baseline to 3rd month. |
| post hoc Newman-Keuls |
| <0.001 |
| Effect size |
| 1.07 |
| 2-Sided |
| No |
| Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 1.31 | 2-Sided | No | Superiority or Other |
| From baseline to 3rd month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.71 | 2-Sided | No | Superiority or Other |
| From baseline to 6th month. | post hoc Newman-Keuls | <0.001 | Effect size | 0.45 | 2-Sided | No | Superiority or Other |
| Six-minute walk test (6th month) |
|