Trial Outcomes & Findings for Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot (NCT NCT00494143)

Results Overview

VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

Results posted on

2014-06-09

Participant Flow

subjects were recruited through bulletin board ads and through a local VA amputee clinic. Subjects were included if between the ages of 18 and 80 years, had used a prosthesis for grtr than 2 years, wore the prosthesis grtr than 8 hours per day, did not ambulate with u/e aids and had no falls in the prior 6 mo or known neuro or msk deficits.

Subjects were provided with suitable acclimatization prior to testing with their initial randomized prosthetic foot type.

Participant milestones

Participant milestones
Measure	Conventional, Prescribed, CESR this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot	Conventional, CESR, Prescribed The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.	Prescribed, CESR, Conventional The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot	CESR, Prescribed, Conventional This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
Overall Study STARTED	1	2	3	1
Overall Study COMPLETED	1	2	3	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CESR, Prescribed, Conventional n=7 Participants all subjects were randomized to each of the three interventions
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 12 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants
stature	1.85 meters STANDARD_DEVIATION .05 • n=93 Participants
Body Weight	80.9 kilograms STANDARD_DEVIATION 9.9 • n=93 Participants

PRIMARY outcome

Timeframe: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.

Outcome measures

Outcome measures
Measure	CESR Experimental Prosthetic Foot n=7 Participants the CESR, controlled energy storage prosthetic foot CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle	Conventional Prosthetic Foot n=7 Participants subjects wearing the conventional prosthetic foot	Prescribed Prosthetic Foot n=7 Participants subjects wearing the prescribed prosthetic foot
Metabolic Oxygen Consumption During Ambulation	3.45 Watts per kilogram Standard Deviation 0.59	3.13 Watts per kilogram Standard Deviation 0.33	2.97 Watts per kilogram Standard Deviation 0.23

SECONDARY outcome

Timeframe: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase. The peak power output during the push off component of stance phase was calculated in Joules. It was subsequently standardized for body weight in Kgs. The final units were therefore Joules/Kg.

Outcome measures

Outcome measures
Measure	CESR Experimental Prosthetic Foot n=7 Participants the CESR, controlled energy storage prosthetic foot CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle	Conventional Prosthetic Foot n=7 Participants subjects wearing the conventional prosthetic foot	Prescribed Prosthetic Foot n=7 Participants subjects wearing the prescribed prosthetic foot
Prosthetic Foot Push Off Peak Power	0.27 joules per kilogram Standard Deviation 0.04	0.11 joules per kilogram Standard Deviation 0.03	0.15 joules per kilogram Standard Deviation 0.04

SECONDARY outcome

Timeframe: Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

The biomechanical measure of the first peak of the knee external adduction moment

Outcome measures

Outcome measures
Measure	CESR Experimental Prosthetic Foot n=7 Participants the CESR, controlled energy storage prosthetic foot CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle	Conventional Prosthetic Foot n=7 Participants subjects wearing the conventional prosthetic foot	Prescribed Prosthetic Foot n=7 Participants subjects wearing the prescribed prosthetic foot
Peak Intact Knee Loading	0.451 newton meters per kilogram Standard Deviation 0.144	0.608 newton meters per kilogram Standard Deviation 0.169	0.509 newton meters per kilogram Standard Deviation 0.132

Adverse Events

Arm 3 CESR Prosthetic Foot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1 Conventional Prosthetic Foot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Prescribed Prosthetic Foot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Czerniecki

VA Puget Sound Health Care System

Phone: 206 277 5188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place