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Prosthetics

Powered Prosthetic Knee for Below Knee Amputation

N/A

Recruiting

Led By Michael Davidson, Ph.D.

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline visit (study enrollment)

Awards & highlights

Study Summary

This trial tests if a powered knee improves walking for those with prostheses, compared to what the doctor prescribed.

Who is the study for?

This trial is for men and women aged 18-75 who have lost one leg above the knee, weigh between 49-117 kg, walk or play sports with a prosthesis daily, and have been doing so for at least six months without recent socket issues or limb pain that affects function.Check my eligibility

What is being tested?

The study aims to determine if a powered microprocessor-controlled knee (PMPK) can improve how efficiently people use energy while walking on flat ground and slopes compared to their usual physician-prescribed prosthetic knees.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort adjusting to the PMPK device, skin irritation from the new fitting, muscle strain during adaptation period, or falls due to unfamiliarity with the powered knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between visit 2 (3 weeks post-study enrollment) and visit 3 (4 weeks post-study enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between visit 2 (3 weeks post-study enrollment) and visit 3 (4 weeks post-study enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between visit 2 (3 weeks post-study enrollment) and visit 3 (4 weeks post-study enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VO2 uptake - incline

VO2 uptake - level ground

Secondary outcome measures

Balance confidence

Exertion

Trial Design

1Treatment groups

Experimental Treatment

Group I: Powered Microprocessor-controlled Knee (PMPK)Experimental Treatment1 Intervention

the "Power Knee" is a commercially available PMPK.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Össur EhfIndustry Sponsor

20 Previous Clinical Trials

3,855 Total Patients Enrolled

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,976 Total Patients Enrolled

Michael Davidson, Ph.D.Principal InvestigatorLoma Linda University Health

Media Library

PMPK (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05831696 — N/A

Below Knee Amputation Research Study Groups: Powered Microprocessor-controlled Knee (PMPK)

Below Knee Amputation Clinical Trial 2023: PMPK Highlights & Side Effects. Trial Name: NCT05831696 — N/A

PMPK (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831696 — N/A

Frequently Asked Questions

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

Are individuals aged 18 or older eligible to join this experiment?

"This research study is open to participants aged 18 or over, but no older than 75."

Answered by AI

Are there any vacancies for prospective participants in this clinical trial?

"This investigation has been actively recruiting participants since February 27th 2023, as evidenced on clinicaltrials.gov and was most recently revised on April 14th of the same year."

Answered by AI

Could you provide an estimate of the number of people involved in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is currently in search of volunteers - the trial was first made available on February 27th 2023 and has been updated as recently as April 14th 2023. 12 patients must be sought out from a single site for inclusion in the study."

Answered by AI

May I partake in this medicinal experiment?

"Prospective enrollees must have a below knee amputation and be positioned between 18 to 75 years old. As of now, this clinical trial is looking for around 12 volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss

Michael Davidson 2023. "Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05831696.