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Prosthetics

Hybrid Prosthetic Leg for Amputation

N/A
Recruiting
Led By Levi Hargrove, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A unilateral or bilateral lower limb amputation
K2/K3/K4 ambulator with a prosthesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
Awards & highlights

Study Summary

This trial is testing a new, lightweight powered leg controlled using an intent recognition framework. The benefits will be determined in laboratory and community environments.

Who is the study for?
This trial is for individuals with a single or double lower limb amputation who currently use a prosthesis and can walk at various speeds (K2/K3/K4 level). Participants must speak English to understand the study and give feedback. Those with cognitive impairments, other serious health issues, or new injuries that prevent prosthesis use cannot join.Check my eligibility
What is being tested?
The study tests an advanced powered prosthetic leg called 'Hybrid Leg' against the standard passive prosthesis prescribed to patients. The Hybrid Leg uses a special system designed to recognize the user's movement intentions in both lab settings and everyday life scenarios.See study design
What are the potential side effects?
While specific side effects are not detailed, potential issues may include discomfort while adjusting to the Hybrid Leg's control system, skin irritation from prolonged wear of the device, or muscle strain due to different walking dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had one or both of my legs amputated.
Select...
I can walk with a prosthesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average daily number of steps
Average daily number of times subject switches between activities
Secondary outcome measures
10 Meter Walk Test
4 -Square Step Test
5 Times Sit to Stand
+7 more
Other outcome measures
Falls-Efficacy Scale
Orthotics and Prosthetics User Survey
Prosthesis Evaluation Questionnaire
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Condition B: Passive LegExperimental Treatment1 Intervention
Subject will use their currently prescribed home passive prosthesis
Group II: Condition A: Hybrid LegExperimental Treatment1 Intervention
Subject will be trained on use of the experimental device, the Hybrid Leg.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,710 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,892 Total Patients Enrolled
Levi Hargrove, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
4 Previous Clinical Trials
302 Total Patients Enrolled

Media Library

Hybrid Leg (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT04038151 — N/A
Amputation Research Study Groups: Condition A: Hybrid Leg, Condition B: Passive Leg
Amputation Clinical Trial 2023: Hybrid Leg Highlights & Side Effects. Trial Name: NCT04038151 — N/A
Hybrid Leg (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038151 — N/A

Frequently Asked Questions

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

How many subjects are enrolled in this experiment?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this medical research, which was initially published in December 2018, is currently seeking participants. Approximately 20 individuals must be recruited from 1 centre to complete the trial."

Answered by AI

Are there any remaining openings for participants in this experiment?

"Affirmative. The clinical trial's webpage on clinicaltrials.gov conveys that it is presently recruiting participants, with the first listing being posted on December 1st 2018 and its most recent amendment being made on November 14th 2022. This research necessitates 20 individuals from one medical centre to take part in their study."

Answered by AI

Am I eligible to join the experiment?

"This trial seeks to enroll 20 individuals, aged between 18 and 95 years old with a lower limb amputation. Moreover, the ideal candidates must be K2/K3/K4 ambulators who use a prosthesis and are capable of conversing in English."

Answered by AI

Is this investigation actively seeking elderly individuals as participants?

"This research trial is inclusive of patients over 18 and under 95 years old."

Answered by AI

What is the principal aim of this research project?

"The 4-week in-home trial of the device is designed to assess average daily number of steps. Secondary outcomes include GPS tracking analysis, Six Minute Walk Test and Four Square Step Test; all aimed at evaluating changes in community mobility as well as aerobic capacity and dynamic balance respectively."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
South Dakota
How old are they?
18 - 65
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
Levi Hargrove 2018. "Intuitive Control of a Hybrid Prosthetic Leg During Ambulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038151.
~3 spots leftby Apr 2025
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