Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francis Trombini, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01342458
First received: April 20, 2011
Last updated: January 11, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Other: Flexible footwear
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Inexpensive, Flexible and Non-heeled Footwear on the Clinical, Functional and Gait Biomechanics in Elderly Women With Knee Osteoarthritis: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) Pain Subscale [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • WOMAC Stiffness Subscale [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • WOMAC Physical Function Subscale [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • WOMAC Total Score [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • Global Score of the Lequesne´s Questionaire Algo-functional. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • Six-minute Walk Test [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    The six-minute walk test assesses distance in meters walked over 6 minutes.

  • First Peak of the Knee Adduction Moment (KAM) During Gait. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • Paracetamol Intake [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Paracetamol intake (500 mg), number of tablets per month.


Enrollment: 56
Study Start Date: March 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
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.
Other: Flexible footwear
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.
No Intervention: Control Group
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.

Detailed Description:
  • The clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6MWT).
  • Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics.

The process (steps) will be divided as follows:

  • step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait.
  • step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires.
  • step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.
  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kellgren and Lawrence grade 2 or 3
  • Being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
  • Knee pain between 3 and 8 on the visual analogue scale

Exclusion Criteria:

  • Previous history of surgery on knees, ankles and hips in the last 2 years
  • Neurological disease
  • BMI > 35 kg/m2
  • Difference in lower limb length > 1 cm
  • Prostheses and / or lower limb orthoses
  • Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
  • Present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
  • OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine
  • Inflammatory arthritis (eg. rheumatoid arthritis)
  • Asymptomatic OA of one or both knees
  • Dementia or inability to provide consistent information
  • Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
  • Being under physiotherapy or acupuncture treatment
  • Patients with an indication of prosthesis or orthosis
  • Patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342458

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Isabel CN Sacco, PhD Department of Physical therapy, Speech, and Occupational Therapy, School of Medicine, University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francis Trombini, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01342458     History of Changes
Other Study ID Numbers: LABIMPH_OA2
Study First Received: April 20, 2011
Results First Received: November 6, 2014
Last Updated: January 11, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Knee osteoarthritis
Shoes
Gait
Biomechanics

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 28, 2015