To identify outcome domains of importance to adults undergoing prosthetic rehabilitation following lower limb amputation in low- and middle-income countries (LMICs), based on their lived experiences described in qualitative literature.

Systematic review and qualitative synthesis informed by a critical realist perspective and reported according to ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) guidelines.

CINAHL, PsycInfo, Web of Science and Trip databases were searched from inception to April 2024.

We included qualitative studies exploring the views and experiences of adults (≥18 years) using lower limb prosthesis in LMICs (World Bank definition). Studies including upper limb amputees, non-prosthetic users, mixed samples that could not be disaggregated or not reporting first-person accounts were excluded.

Two reviewers independently screened studies using predefined criteria. Data were extracted from results sections, including participant quotations and author interpretations. Reflexive thematic analysis was conducted to identify outcome domains across studies. Study quality was appraised using the CASP (Critical Appraisal Skills Programme) qualitative checklist; no studies were excluded based on quality.

Five studies involving 55 participants from Nepal, Kenya, Cambodia, Bangladesh and Kiribati met the inclusion criteria. Four outcome domains were identified: (1) The importance of a prosthesis: highlighting access, socket comfort, durability and functional suitability; (2) valued activities: particularly the importance of work and participation in daily living tasks; (3) acceptance following limb loss: encompassing community participation and self and social acceptance; and (4) independence: including reduced reliance on family and greater control over daily life. Across settings, participants emphasised prosthesis durability, work participation and culturally relevant function.

Evidence on meaningful outcomes of prosthetic rehabilitation in LMICs is extremely limited. Findings indicate that access to a comfortable and durable prosthesis enabling work and daily living is central to recovery, alongside social acceptance and independence. These domains may provide initial insights into outcome measurement and development in low-resource settings. Further primary research across diverse LMIC contexts is urgently needed.

Difficulty with walking can lead to reduced quality of life for people with Parkinson’s disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.

Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD.

STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES.

This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access.

ISRCTN13120555.