Osteoporosis
Conditions
Keywords
elderly, balance, insole, foot orthosis, orthotics
Brief summary
The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.
Detailed description
Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.
Interventions
DEVICEFoot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)
Custom foot orthoses made of ethylene-vinyl acetate (EVA) with medial arch supports and metatarsal pads (supporting the diaphysis of the second to fourth metatarsals) that were manufactured by the Orthotics and Prostheses Unit of the Clinical Hospital of UNICAMP.
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of osteoporosis
Exclusion criteria
* reduced tactile and thermal foot sensibility * compromised skin integrity of the lower limbs * autoimmune rheumatic diseases * vestibular symptoms * central nervous system pathologies * peripheral neuropathy * use of insoles in the last month * lower limb prostheses * previous history of foot surgery * amputation of the lower limbs * inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) | 4 weeks | The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking. |
| Timed up and Go Test (TUG) | 4 weeks | The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale | 4 weeks | Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain) |
| Manchester Foot and Pain Disability Index(MFPDI) | 4 weeks | The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability. |
Countries
Brazil
Participant flow
Recruitment details
From April 2011 to October 2011, patients in treatment in the outpatient clinic of the Rheumatology Division of Unicamp, who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assessed.
Pre-assignment details
From the 242 patients considered eligible, 148 were not included due exclusing criteria (compromised skin integrity of the lower limbs, autoimmune rheumatic diseases, vestibular symptoms, central nervous system pathologies, peripheral neuropathy, use of insoles in the last month, previous foot surgery, inability to attend the reevaluations).
Participants by arm
| Arm | Count |
|---|---|
| Foot Orthosis Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks. | 47 |
| Control Group Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks. | 47 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Foot Orthosis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 43 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 4 Participants | 12 Participants |
| Age Continuous | 72.04 years STANDARD_DEVIATION 7.14 | 72.38 years STANDARD_DEVIATION 6.83 | 72.38 years STANDARD_DEVIATION 6.83 |
| Region of Enrollment Brazil | 47 participants | 47 participants | 94 participants |
| Sex: Female, Male Female | 47 Participants | 47 Participants | 94 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 47 | 0 / 0 |
| serious Total, serious adverse events | 0 / 47 | 0 / 0 |
Outcome results
Primary
Berg Balance Scale (BBS)
The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.
Time frame: 4 weeks
Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot Orthosis | Berg Balance Scale (BBS) | 50.68 scores on a scale | Standard Deviation 4.18 |
| Control Group | Berg Balance Scale (BBS) | 43.13 scores on a scale | Standard Deviation 6.24 |
Primary
Timed up and Go Test (TUG)
The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.
Time frame: 4 weeks
Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot Orthosis | Timed up and Go Test (TUG) | 11.97 seconds | Standard Deviation 2.8 |
| Control Group | Timed up and Go Test (TUG) | 15.82 seconds | Standard Deviation 3.23 |
Secondary
Manchester Foot and Pain Disability Index(MFPDI)
The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability.
Time frame: 4 weeks
Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot Orthosis | Manchester Foot and Pain Disability Index(MFPDI) | 11.48 scores on a scale | Standard Deviation 5.56 |
| Control Group | Manchester Foot and Pain Disability Index(MFPDI) | 22.64 scores on a scale | Standard Deviation 9.2 |
Secondary
Numeric Pain Scale
Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)
Time frame: 4 weeks
Population: A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foot Orthosis | Numeric Pain Scale | 1.68 units on a scale | Standard Deviation 2.46 |
| Control Group | Numeric Pain Scale | 4.20 units on a scale | Standard Deviation 3.07 |