Phase 3 N=7 Randomized Treatment

Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot

Transtibial Amputation

Bottom Line

View on ClinicalTrials.gov: NCT00494143 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Metabolic Oxygen Consumption During Ambulation — 3.45; 3.13; 2.97 Watts per kilogram

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CESR Prosthetic Foot (Device); typical prosthetic foot (Device); standardized prosthetic foot (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Metabolic Oxygen Consumption During Ambulation	3.45; 3.13; 2.97	—
SECONDARY Prosthetic Foot Push Off Peak Power	0.27; 0.11; 0.15	—
SECONDARY Peak Intact Knee Loading	0.451; 0.608; 0.509	—

Summary

To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.

Eligibility Criteria

Inclusion Criteria

Transtibial Amputees > 1 year walking with prosthesis
Non-amputee control subjects

Exclusion Criteria

Additional musculoskeletal pathology
Cognitive limitation

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Data sourced from ClinicalTrials.gov (NCT00494143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.