Trial reportGerontology2019
Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial.
Trial report in Gerontology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02819011 (OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Effects of balance training on balance and fall efficacy in patients with Osteoporosis: A systematic review and meta-analysis with trial sequential analysis.Journal of rehabilitation medicine · 2023Pooled it
- Feet/Footwear-Related Fall Risk Screening Tool for Older Adults: Development and Content Validation.Frontiers in public health · 2021Pooled it
- The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy.Journal of diabetes science and technology · 2019Trial
- Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial.Journal of the American Geriatrics Society · 2019Trial
- Article
- Modifiable determinants of older adults' physical activity and sedentary behavior in community and healthcare settings: a DE-PASS systematic review and meta-analysis.European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity · 2025Article
- Neck Collar Assessment for People Living With Motor Neuron Disease: Are Current Outcome Measures Suitable?Interactive journal of medical research · 2023Article
- Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients.Journal of diabetes science and technology · 2023Article
- Mobility experiences of adult lower limb orthosis users: a focus group study.Disability and rehabilitation · 2022Article
- Knee-High Devices Are Gold in Closing the Foot Ulcer Gap: A Review of Offloading Treatments to Heal Diabetic Foot Ulcers.Medicina (Kaunas, Lithuania) · 2021Review
- Improvement of Gait Dysfunction after Applying a Hinged Ankle-Foot Orthosis in a Hemiplegic Cerebral Palsy Patient with Disrupted Medial Lemniscus: A Case Report.Children (Basel, Switzerland) · 2021Article
- The Impact of Ankle-foot Orthoses on Balance in Older Adults: a Scoping Review.Canadian prosthetics & orthotics journal · 2021Article
- Characteristics of the gait initiation phase in older adults with diabetic peripheral neuropathy compared to control older adults.Clinical biomechanics (Bristol, Avon) · 2020Article
- Sensor-Based Daily Physical Activity: Towards Prediction of the Level of Concern about Falling in Peripheral Neuropathy.Sensors (Basel, Switzerland) · 2020Article
- The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial.Frontiers in aging neuroscience · 2020Article
- Kinematic on Ankle and Knee Joint of Post-Stroke Elderly Patients by Wearing Newly Elastic Band-Type Ankle-Foot Orthosis in Gait.Clinical interventions in aging · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundFoot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated.
objectiveThis randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. STUDY
designForty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up.
resultsNo significant between-group difference was observed at baseline (p = 0.144-0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005-0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122-0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = -0.484, p = 0.047) and strongly correlated with baseline COM sway (r = -0.903, p < 0.001).
conclusionResults suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.