Fear of Falling Clinical Trial
Official title:
A Randomised Control Trial Comparing Prefabricated Orthotics With and Without Metatarsal Pad in Decreasing Pain and Fear of Falling in Older Adults
Verified date | May 2023 |
Source | Talita Cumi Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 206 |
Est. completion date | January 15, 2023 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Talita Cumi LTD. | Southport | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Talita Cumi Ltd. | Aetrex Worldwide Inc |
United Kingdom,
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Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Analysis of foot structure using the Gaitway scanner. | All the participants would undergo analysis with the Gaitway scanner. The results of the scanner will only be documented for purposes of the study and the results of the scanning will not be used to determine the Orthotic the individual participant receives. | Baseline | |
Other | Report how many hours, on average, the orthotics are worn each day. | Participants will be required to report how many hours, on average, the Orthotics were worn each day <4 hours, 4 to 8 hours, > 8 hours. | 6 weeks | |
Primary | Changes in pain as assessed by a Visual Analogue Scale (VAS) | 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. | Baseline and 6 weeks | |
Secondary | Changes in foot pain & functionality as assessed by the Foot Health Status Questionnaire (FHSQ) | Foot Pain & Functionality scores will be collected using the FHSQ or Foot Health Status Questionnaire. The Foot Health Status Questionnaire is designed to assess foot pain, foot health and its relation to quality of life. The questionnaire has four domains consisting of 13 key items. The four domains are; foot pain, foot function, footwear and general foot health. The current study will only use the 2 subsections of Foot Pain and Foot Function. In these subsections, participants will be required to rate foot pain in the last week from 1 (none) to 5 (severe), how often the participant experienced different types of foot pain during the last week from 1 (never) to 5 (always), how much the participants feet interfered with everyday activities in the last week from 1 (not at all) to 5 (extremely) and overall foot health from 1 (excellent) to 5 (poor). Previous research has found the FHSQ to exhibit a strong degree of context, criterion and construct validity with high retest reliability. | Baseline and 6 weeks | |
Secondary | Fear of falling as assessed by the Falls Efficacy Scale International (FES-I) short. | Fear of falling will be measured using the Falls Efficacy Scale International (FES-I) short, The Falls Efficacy Scale-International (FES-I) (short) is a 7-item version of the FES-I. The questionnaire will ask participants to rate the concern about the possibility of falling when completing everyday tasks on a scale of 1 to 4 (where 1 = not at all concerned and 4 = very concerned). This version has been validated for community-dwelling older population. Furthermore, the short FES-I can predict future falls, muscle weakness, frailty and overall disability. | Baseline and 6 weeks |
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