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Metabolic Cost of Walking With Passive vs. Powered Microprocessor Controlled Knees

NCT05048355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-08

No results posted yet for this study

Summary

This study is conducted to evaluate the efficacy of the Power Knee Mainstream Dynamic compared to passive microprocessor-controlled knees (MPKs) regarding metabolic cost for high active transfemoral amputees.The test is of a single group repeated measures crossover design. The primary endpoint is the difference in MET/HRI-VO2 index between conditions. Subjects are measured on their prescribed device at visit 1, be fitted to the PKM which they wear as their primary prosthesis for one week before coming for visit 2 and being measured again on the PKM.

Conditions

  • Amputation
  • Prosthesis User

Interventions

DEVICE

Power Knee Mainstream Dynamic

Powered Microprocessor controlled prosthetic knee. The Power Knee Mainstream - Dynamic, was designed to provide powered swing dynamics to restore muscle activity and thereby attempting to mitigate this increase in metabolic cost that individuals living with TF amputation face.

DEVICE

Passive microprocessor controlled knee

Any passive microprocessor controlled prosthetic knee on the market

Sponsors & Collaborators

  • Össur Iceland ehf

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2021-08-25
Completion
2021-08-25

Countries

  • Germany
  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05048355 on ClinicalTrials.gov