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

Unilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05895253
• Other study ID #: IPS002
• Status: Terminated
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: May 6, 2022

Study information

• Verified date: June 2023
• Source: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Unilateral

Intervention

Device:
• vibrotactile ground-contact feedback
Suralis®, Saphenus Medical Technology (Baden, Lower Austria, Austria)

Locations

Country	Name	City	State
Austria	Ordination Dr. Wolfgang Schaden	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA	Saphenus Medical Technology GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Gait speed treatment-change difference	Average speed of walking over level ground and on a 518 cm instrumented walkway at a self-selected speed	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	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	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	Quality of life score treatment-change difference	EuroQol (EQ) 5-Dimension (5D) 3-Level (3L) version, visual analog scale (VAS)	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
Secondary	Adverse effects frequency treatment difference	Patient diary documentation and interview regarding adverse effects	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
Secondary	Timed up and go test time treatment-change difference	Stand up, walk 3 m, turn around, and sit down	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	2 min walk test distance treatment-change difference	Walking distance in meters within a 2 min 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
Secondary	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	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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