NCT05048355

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

Name: Clinical Trial NCT05048355
Creator: Össur Ehf
Keywords: Amputation,Prosthesis User, Power Knee Mainstream Dynamic, device, clinical trial, Germany,Iceland

Metabolic Cost of Level Ground Walking With Passive vs. Powered Microprocessor Controlled Knees for Higher Active TF Amputees

Össur Ehf·ClinicalTrials.gov·device·Device trialCompleted

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Amputation,Prosthesis User
Drug/Device/Intervention: Power Knee Mainstream Dynamic
Study type: Interventional
Intervention type: device

Sponsor & location

Primary sponsor: Össur Ehf
Location: Bayreuth,Reykjavík, Germany,Iceland

Timeline & enrollment

Phase: N/A
Start date: May 26, 2021
End date: Aug 25, 2021
Enrollment: 15 participants

Primary outcome

Metabolic cost

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.

ICD-10 classifications

Amputation of limb(s)Traumatic amputation of upper and lower limbs, any combination [any level]Traumatic amputations involving other combinations of body regionsTraumatic amputation of one hand and other arm [any level, except hand]Traumatic amputation of lower limb, level unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05048355
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT05048355 through Pure Global AI's free database. This phase not specified trial is sponsored by Össur Ehf and is currently Completed. The study focuses on Amputation,Prosthesis User. Target enrollment is 15 participants.

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