Clinical trial NCT04894396: Orthotics, Pain & Fear of Falling
Official title: A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Pain
Foot Functionality
Fear of Falling
Lead sponsor: Talita Cumi Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Aetrex Worldwide Inc
First posted: 2021-05-20
Enrollment: 206
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ)
timeFrame: Baseline and 6 weeks
measure: Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short.
timeFrame: Baseline and 6 weeks
Other outcomes:
measure: Analysis of foot structure using the Gaitway scanner.
timeFrame: Baseline
measure: Report how many hours, on average, the orthotics are worn each day.
timeFrame: 6 weeks
Locations:
city: Southport
country: United Kingdom
facility: Talita Cumi LTD.
state: Merseyside
Study officials:
affiliation: Talita Cumi Ltd.
name: George Ampat, MBBS, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
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