Background The benefits of exercise and staying active are widely reported in the literature, however adherence and engagement with exercise amongst people with long-term illness and diabetes is poor. Physiotherapy aims to promote independence and physical activity using a range of strategies, including manual therapy and education/advice on exercises. However, low adherence impacts negatively on treatment outcomes. In this study, the practicality of physiotherapy interventions in patients who participate in a proof-of-concept (PoC) randomised controlled trial (RCT) will be considered. Aim To explore the experiences of people with diabetes who received an intervention package of foot and ankle mobilisations combined with home stretches for a 6-week period. Design An embedded qualitative study in a proof-of-concept RCT using semi-structured interviews and thematic analysis. Participants Purposive sample of 16 participants (mean age 73 years) with a diagnosis of diabetes (mean duration 13.4 years) were recruited. Results Analysis revealed seven themes informing the adherence and non-adherence to the exercise intervention. Themes describing the positive experiences were: 1) support from others to do the exercises; 2) psychological factors to motivate exercise adherence; 2) physical factors contributing to exercise adherence; 4) acceptability of home exercises during and beyond the study. Other themes described barriers: 5) social factors that contributed to exercise disengagement; 6) emotional limitations that influence exercise avoidance; 7) physical circumstances that made exercise participation burdensome. Themes highlighted positive influences by physiotherapists, the motivation of doing exercises while participating in a study, improving the perceived range of motion in their foot and ankle and reducing discomfort in these joints whilst being more active with daily activities. Conclusion Our findings highlighted that the intervention of foot and ankle mobilisations combined with home stretches is feasible for study participants. Psycho-social support, self-efficacy, and physiotherapy support are motivational to adhere to the study intervention and might contribute to the success of a full-scale RCT.
IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.
To evaluate the effects of foot and ankle physical therapy on ankle and first metatarsophalangeal joint range of motion (ROM), peak plantar pressures (PPPs) and balance in people with diabetes. MEDLINE, EBSCO, Cochrane Database of Systematic Reviews, Joanna Briggs Institute Database of Systematic Reviews, PROSPERO, EThOS, Web of Science and Google Scholar were searched in April 2022. Randomised Controlled Trials (RCT), quasi‐experimental, pre‐post experimental design and prospective cohort studies were included. Participants were people with diabetes, neuropathy and joint stiffness. Interventions included physical therapy such as mobilisations, ROM exercises and stretches. Outcome measures focused on ROM, PPPs and balance. Methodological quality was assessed with Critical Appraisal Skills Programme RCT and Risk‐of‐Bias 2 tool. Meta‐analyses used random‐effects models and data was analysed using the inverse variance method. In total, 9 studies were included. Across all studies, participant characteristics were similar; however, type and exercise dosage varied greatly. Meta‐analysis was performed with four studies. Meta‐analysis showed significant effects of combined exercise interventions in increasing total ankle ROM (3 studies: MD, 1.76; 95% CI, 0.78–2.74; p = 0; I2 = 0%); and reducing PPPs in the forefoot area (3 studies; MD, −23.34; 95% CI, −59.80 to 13.13; p = 0.21, I2 = 51%). Combined exercise interventions can increase ROM in the ankle and reduce PPPs in the forefoot. Standardisation of exercise programmes with or without the addition of mobilisations in the foot and ankle joints needs further research.
Introduction People with diabetic peripheral neuropathy (DPN) and limited joint mobility syndrome (LJMS) can experience increased forefoot peak plantar pressures (PPPs), a known risk factor for ulceration. The aim of this study was to investigate whether ankle and 1st metatarsophalangeal (MTP) joint mobilisations and home stretches in people with DPN improve joint range of motion (ROM) and reduce forefoot PPPs. Design and methods Sixty-one people with DPN (IWGDF risk 2), were randomly assigned to a 6-week programme of ankle and 1st MTP joint mobilisations (n = 31) and home stretches or standard care only (n = 30). At baseline (T0); 6-week post intervention (T1) and at 3 months follow-up (T2), a blinded assessor recorded dynamic ankle dorsiflexion range using 3D (Codamotion) motion analysis and the weight bearing lunge test, static 1st MTP joint, dynamic plantar pressure and balance. Results No significant differences in dynamic ankle dorsiflexion were found between both groups. A statistically significant difference was observed in ankle dorsiflexion range in both feet across time between groups (Left 1.52cm and 2.9cms, Right 1.62cm and 2.7cm) at 6 (T1) and 18 weeks (T2) respectively p < 0.01). Between both groups, a significant increase in functional reach was observed (T1 = 3.13cm p < 0.05 and T2 = 3.9cm p < 0.01). Between group differences were seen in left hallux dorsiflexion (2.75°, p < 0.05) at T1 and in right hallux dorsiflexion (4.9°, p < 0.01) at T2 follow up. No significant between group differences were found for peak plantar pressure or postural sway. Intervention adherence was high (80%). Conclusions Combining ankle and 1st MTP joint mobilisations with home stretches in a 6-week programme in people with DPN is effective in increasing static measures of range. This intervention may be useful for improving ankle, hallux joint mobility and anteroposterior stability limits in people with diabetes and neuropathy but not for reducing PPP or foot ulcer risk. Trial registration https://classic.clinicaltrials.gov/ct2/show/NCT03195855
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