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

NCT05048355 | Completed

• 1 other identifier: CII2021050747
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Metabolic cost; Powered prosthetics; Microprocessor controlled knees; MPKs

Outcome Measures

Primary Outcomes (1)

• Metabolic cost

  MET/HRI-VO2 index

  1 week

Study Arms (1)

Power Knee Mainstream Dynamic

EXPERIMENTAL

Users are measured using their prescribed microprocessor knee and after wearing the Power Knee Mainstream dynamic for the adaptation period, they are measured again.

Device: Power Knee Mainstream Dynamic; Device: Passive microprocessor controlled knee

Interventions

Power Knee Mainstream Dynamic DEVICE

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.

Power Knee Mainstream Dynamic

Passive microprocessor controlled knee DEVICE

Any passive microprocessor controlled prosthetic knee on the market

Power Knee Mainstream Dynamic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kg\< body weight \< 116Kg
• Cognitive ability to understand all instructions and questionnaires in the study;
• Higher active unilateral trans-femoral amputees
• Allows for 37mm knee center height to dome of pyramid alignment to allow for symmetrical knee height to sound side
• Willing and able to participate in the study and follow the protocol
• Comfortable and stable socket fit
• No socket issues/changes in the last 6 weeks
• No residual limb pain affecting functional ability
• Users with at least 6 months experience on a prosthesis

You may not qualify if:

• Hip disarticulation amputees
• Bilateral amputees
• Users with Osseointegrated prosthesis
• Users with co-morbidities in the contra-lateral limb, which significantly affect their functional mobility
• Users taking beta-adrenergic blocking agents (beta blockers) or other medication for heart rate control e.g. Verapamil \& Digoxin.

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (2)

Össur Germany

Bayreuth, Bavaria, 95448, Germany

Location

Össur HQ

Reykjavik, 110, Iceland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single group repeated measures crossover design

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 17, 2021
• Study Start: May 26, 2021
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: October 8, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1); DE (1)