Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation

Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Status: Terminated

Conditions: Amputation of Lower Limb Below Knee; Unilateral

Treatments: Device: vibrotactile ground-contact feedback

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05895253

IPS002

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 18 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups

Control-Vibration

Active Comparator group

Description:

Participants were assessed before and after 60 days of no additional intervention to any ongoing treatment, after seven days of washout, and after receiving 60 days of vibrotactile ground-contact feedback.

Treatment:

Device: vibrotactile ground-contact feedback

Vibration-Control

Active Comparator group

Description:

Participants were assessed before and after receiving 60 days of vibrotactile ground-contact feedback, after seven days of washout, and after 60 days of no additional intervention to any ongoing treatment.

Treatment:

Device: vibrotactile ground-contact feedback