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Prosthetic Device

DSR Ankle Prosthesis for Amputation

N/A
Recruiting
Research Sponsored by Synchro Motion LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
K2 level ambulators
Adults aged 18-89 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after up to 3 weeks of training
Awards & highlights

Study Summary

This trial investigates a new prosthetic ankle that can help people walk on uneven ground & bend their ankle safely. It's for those rated as K2-level ambulators.

Who is the study for?
This trial is for adults aged 18-89 who have lost one leg below the knee and can walk with a prosthesis. It's specifically for those who are K2-level ambulators, meaning they can handle low-level walking activities but currently use a non-computer-controlled prosthetic ankle.Check my eligibility
What is being tested?
The study is testing a new microprocessor-controlled prosthetic ankle called the DSR Ankle against an existing type of prosthetic ankle (Predicate Ankle). The goal is to see if the DSR improves walking on different surfaces and step clearance.See study design
What are the potential side effects?
Since this trial involves mechanical devices rather than drugs, 'side effects' may include discomfort or skin issues where the prosthesis attaches, potential falls during adjustment to new device dynamics, or muscle strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk with some assistance.
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I am between 18 and 89 years old.
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I use a non-computerized prosthesis for my one below-knee amputation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after up to 3 weeks of training
This trial's timeline: 3 weeks for screening, Varies for treatment, and after up to 3 weeks of training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Center of Pressure RMS Velocity
Maximum Lyapunov Exponent
Minimum Foot Clearance
+2 more
Secondary outcome measures
10 Meter Walk Test (10 MWT)
Berg Balance Test (BBS)
Borg Rating Scale (RPE)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DSR AnkleExperimental Treatment1 Intervention
The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector.
Group II: Predicate AnkleActive Control1 Intervention
The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living.

Find a Location

Who is running the clinical trial?

Synchro Motion LLCLead Sponsor
Shirley Ryan AbilityLabOTHER
194 Previous Clinical Trials
16,907 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are contributing to this research endeavor?

"Affirmative. As per the details present on clinicaltrials.gov, this healthcare study is in search of participants and was first posted on July 15th 2023. The research team wishes to recruit 5 patients from a single location; it has been most recently updated on November 20th 2023."

Answered by AI

Are individuals over 35 years of age eligible to participate in this research study?

"This medical trial has a strict age range requirement set between 18 to 89. In addition, there are 3 trials for minors and 68 studies available for those above 65 years of age."

Answered by AI

Are researchers currently recruiting individuals for this experiment?

"Affirmative, the information found on clinicaltrials.gov reveals that this investigation is in search of participants to participate. This trial was first advertised on July 15th 2023 and has been newly updated as of November 20th 2023. The study requires 5 patients from 1 medical centre for enrollment."

Answered by AI

What are the criteria for joining this medical study?

"This research is seeking 5 participants who are between 18 and 89 years old, have sustained an amputation of the tibia, can use a prosthetic device, and currently utilise a non-MPC passive appliance. Furthermore they must demonstrate K2 level ambulation proficiency."

Answered by AI

What are the foremost aims of this clinical experiment?

"Synchro Motion LLC, the clinical trial sponsor, has determined that Time to Foot Flat shall be measured over a 3 week period as its primary outcome metric. Secondary outcomes include Numerical Pain Rating Scale (NPRS), Borg Rating Scale (RPE) and Modified Falls Efficacy Scale (mFES). The latter covers an individual's confidence about performing daily tasks without falling, while NPRS measures pain intensity on a visual analog scale of 0-10 integers and RPE evaluates effort output and breathlessness during physical activity."

Answered by AI
~1 spots leftby Jul 2024