A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Talita Cumi Ltd.
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Changes in pain as assessed by a Visual Analogue Scale (VAS)
Study Overview
Brief Summary
To investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad in decreasing pain and fear of falling in older adults.
Detailed Description
It is estimated that around 24% of community-dwelling adults over the age of 45 experience frequent foot pain. Falls and fear of falling are also significant issues in this population as both can result in avoidance of activities and decreased physical performance. In cases where fear of falling decreases physical performance and increases activity avoidance, it actually becomes a risk factor for falling itself.
Previous studies have shown that various types of Orthotic insoles improve balance and reduce lower-extremity pain in older adults. However, research which directly compares the effects of two different types of insoles is limited. Hence, this randomised control trial will investigate and compare the use of a prefabricated Orthotic, with and without a metatarsal pad, in decreasing pain and fear of falling in older adults.
This randomised control trial will be conducted over a 6-week period. The study population will include 206 participants who will be randomised into 2 groups (Group A and Group B). Participants in Group A will receive an Orthotic with a metatarsal pad and participants in Group B will receive a neutral Orthotic without the metatarsal pad. All participants will be required to continue with usual activities, using the Orthotic wherever possible for a period of 6 weeks. Participants will be asked to provide data in the form of completed surveys twice, once at the study onset and once at the end.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A least 60 years of age
- •Live in a community-based setting
- •Are capable of ambulation
- •Have some form of self-identified foot pain
Exclusion Criteria
- •Compromised skin integrity of the lower limbs
- •Peripheral neuropathy and lack of sensation in the feet.
- •Previous history of foot surgery and
- •Inability to follow the instructions and procedures of the research protocol.
Arms & Interventions
Prefabricated Orthotics with metatarsal pad
Participants in Group A will receive the Orthotic with the metatarsal pad (L 2305) according to participants shoe size (https://www.aetrex.com/search?q=l2305\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities.
Intervention: Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support (Device)
Prefabricated Orthotics without metatarsal pad.
Participants in Group B will receive the neutral Orthotic with a cupped heel (L 2300) according to participants shoe size (https://www.aetrex.com/search?q=l2300\&search-button=\&lang=en_US). When the investigators provide the Orthotics, an instruction sheet will also be provided, explaining how to use the Orthotic. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. Participants will be required to use the Orthotic wherever possible for a period of 6 weeks, whilst continuing with usual activities
Intervention: Aetrex L2300 Premium Memory Foam Orthotics (Device)
Outcomes
Primary Outcomes
Changes in pain as assessed by a Visual Analogue Scale (VAS)
Time Frame: Baseline and 6 weeks
Pain scores will be collected using the Visual Analogue Scale (VAS) as follows: Levels of pain on a 0 to 10 scale with 0 representing no pain, 2 - mild pain, 5 - moderate pain, 7 - severe pain, and 10 represents extremely severe pain. Utilization of this scale is in line with previous research \[and will measure pain in the feet, ankles, knees, hips, and lower back.
Secondary Outcomes
- Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ)(Baseline and 6 weeks)
- Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short.(Baseline and 6 weeks)