recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected

Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called Suralis© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life.

This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the Suralis© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.

The investigators conducted a prospective, unblinded crossover trial to compare the effectiveness of a vibration intervention with no intervention. Participants were randomly assigned to one of two sequences: vibration intervention followed by no intervention or vice versa. The intervention involved using the Suralis© vibrotactile ground-contact feedback system for 60 days. The system transmitted ground contact information to the residual lateral thigh, providing sensory feedback. During the control phase, participants received no additional intervention. The washout period lasted seven days. The study collected data during four visits, assessing gait and patient-reported measures. Bayesian generalized linear mixed models were used for data analysis, considering fixed effects (intervention, sequence, and period) and random effects (individuality).

Inclusion Criteria:

• male, female, and diverse individuals
• unilateral transtibial amputation
• at least 18 months post surgery
• walking without aids possible
• signed informed consent form

Exclusion Criteria:

• insufficient thigh sensation to distinguish between the two closest vibrotactile actuators
• an acute event that restricts the walking ability
• interfering lesions or painful conditions
• undergone targeted re-innervation surgery
• poor stump condition
• used a non-modular prosthesis
• used a prosthesis in poor condition
• conditions preventing safe participation or interfering with study objectives
• not able to not comply with the protocol

All individual participant data that underlie results in the main publication

At the time of acceptance in a scientific journal

The investigators aim to provide broad, equitable, and maximally open access to the dataset and their metadata free of charge in a timely manner after acceptance, consistent with legal and ethical limits required to maintain privacy and confidentiality, tribal sovereignty, and protection of other sensitive data.