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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Suralis®, Saphenus Medical Technology (Baden, Lower Austria, Austria)
Ordination Dr. Wolfgang Schaden
Vienna, Austria
Affected leg stance time treatment-change difference
Stance time of the prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Time frame: 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
Gait speed treatment-change difference
Average speed of walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Time frame: 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
Unaffected leg step length treatment-change difference
Step length of the non-prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed
Time frame: 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
Quality of life score treatment-change difference
EuroQol (EQ) 5-Dimension (5D) 3-Level (3L) version, visual analog scale (VAS)
Time frame: 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
Adverse effects frequency treatment difference
Patient diary documentation and interview regarding adverse effects
Time frame: 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
Timed up and go test time treatment-change difference
Stand up, walk 3 m, turn around, and sit down
Time frame: 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
2 min walk test distance treatment-change difference
Walking distance in meters within a 2 min time frame
Time frame: 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
Four square step test time treatment-change difference
Do and reverse four steps over 90 cm long canes arranged in a cross configuration on the ground
Time frame: 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
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