Clinical trial NCT05895253: Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
Official title: Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amputation of Lower Limb Below Knee
Unilateral
Keywords: lower limb amputation
somatosensory feedback
functional balance
gait performance
rehabilitation
four square step test
Lead sponsor: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Sponsor class: OTHER_GOV
Collaborators: name: Saphenus Medical Technology GmbH
First posted: 2023-06-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Affected leg stance time treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Secondary outcomes:
measure: Gait speed treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
measure: Unaffected leg step length treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
measure: Quality of life score treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
measure: Adverse effects frequency treatment difference
timeFrame: Difference in the event frequency during the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V - C; once each assessment day
measure: Timed up and go test time treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
measure: 2 min walk test distance treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day
measure: Four square step test time treatment-change difference
timeFrame: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ordination Dr. Wolfgang Schaden
Study officials:
affiliation: Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with the AUVA
name: Gerfried Peternell, MD
role: PRINCIPAL_INVESTIGATOR
References: