Trial Outcomes & Findings for Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study) (NCT NCT04086641)
NCT ID: NCT04086641
Last Updated: 2020-12-14
Results Overview
The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Results posted on
2020-12-14
Participant Flow
Participant milestones
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participants first received a crossover foot, then switched to an energy storing foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection \& subsequent switch.
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participants first received an energy storing foot, then switched to a crossover foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection \& subsequent switch.
|
|---|---|---|
|
Foot 1 (Two Week Utilization)
STARTED
|
2
|
3
|
|
Foot 1 (Two Week Utilization)
COMPLETED
|
1
|
1
|
|
Foot 1 (Two Week Utilization)
NOT COMPLETED
|
1
|
2
|
|
Foot 2 (Two Week Utilization)
STARTED
|
1
|
1
|
|
Foot 2 (Two Week Utilization)
COMPLETED
|
1
|
1
|
|
Foot 2 (Two Week Utilization)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participants first received a crossover foot, then switched to an energy storing foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection \& subsequent switch.
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participants first received an energy storing foot, then switched to a crossover foot. Each foot was utilized for a two week accommodation period at minimum prior to data collection \& subsequent switch.
|
|---|---|---|
|
Foot 1 (Two Week Utilization)
COVID-19
|
1
|
2
|
Baseline Characteristics
Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)
Baseline characteristics by cohort
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
Participants first received a crossover foot, then switched to an energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
Participants first received an energy storing foot, then switched to a crossover foot
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
34 years
n=7 Participants
|
42.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Amputation Etiology
Trauma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Amputation Etiology
Cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
MFCL
K4
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
MFCL
K1-3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot.
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Crossover Foot, Slow Walking Speed
|
0.88 Sound step length / Pros. step length
|
0.87 Sound step length / Pros. step length
|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Energy Storing Foot, Slow Walking Speed
|
1.02 Sound step length / Pros. step length
|
0.91 Sound step length / Pros. step length
|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Crossover Foot, Comfortable Walking Speed
|
0.93 Sound step length / Pros. step length
|
0.91 Sound step length / Pros. step length
|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Energy Storing Foot, Comfortable Walking Speed
|
0.96 Sound step length / Pros. step length
|
0.92 Sound step length / Pros. step length
|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Crossover Foot, Fast Walking Speed
|
0.93 Sound step length / Pros. step length
|
0.94 Sound step length / Pros. step length
|
|
Ratio Between Sound and Prosthetic Side Step Lengths
Energy Storing Foot, Fast Walking Speed
|
0.97 Sound step length / Pros. step length
|
0.97 Sound step length / Pros. step length
|
PRIMARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion \& plantarflexion) during stance phase between prosthetic feet, in degrees
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Total Prosthetic Ankle Range of Motion
Crossover Foot, Slow Walking Speed
|
14.04 degrees
|
14.20 degrees
|
|
Total Prosthetic Ankle Range of Motion
Energy Storing Foot, Slow Walking Speed
|
7.94 degrees
|
9.03 degrees
|
|
Total Prosthetic Ankle Range of Motion
Crossover Foot, Comfortable Walking Speed
|
17.91 degrees
|
16.24 degrees
|
|
Total Prosthetic Ankle Range of Motion
Energy Storing Foot, Comfortable Walking Speed
|
11.17 degrees
|
9.63 degrees
|
|
Total Prosthetic Ankle Range of Motion
Crossover Foot, Fast Walking Speed
|
16.74 degrees
|
17.53 degrees
|
|
Total Prosthetic Ankle Range of Motion
Energy Storing Foot, Fast Walking Speed
|
11.91 degrees
|
11.20 degrees
|
PRIMARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)Intersegmental flow of power out of the prosthesis
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Prosthetic-side Energy Return
Crossover Foot, Slow Walking Speed
|
0.86 W/kg
|
1.27 W/kg
|
|
Prosthetic-side Energy Return
Energy Storing Foot, Slow Walking Speed
|
0.32 W/kg
|
0.36 W/kg
|
|
Prosthetic-side Energy Return
Crossover Foot, Comfortable Walking Speed
|
2.18 W/kg
|
2.32 W/kg
|
|
Prosthetic-side Energy Return
Energy Storing Foot, Comfortable Walking Speed
|
0.90 W/kg
|
0.53 W/kg
|
|
Prosthetic-side Energy Return
Crossover Foot, Fast Walking Speed
|
2.82 W/kg
|
4.22 W/kg
|
|
Prosthetic-side Energy Return
Energy Storing Foot, Fast Walking Speed
|
1.53 W/kg
|
0.75 W/kg
|
PRIMARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)Maximum vertical ground reaction force in early stance
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Peak Sound-side Limb Loading
Crossover Foot, Slow Walking Speed
|
1.06 Ratio (Newtons/body weight)
|
1.04 Ratio (Newtons/body weight)
|
|
Peak Sound-side Limb Loading
Energy Storing Foot, Slow Walking Speed
|
1.06 Ratio (Newtons/body weight)
|
1.16 Ratio (Newtons/body weight)
|
|
Peak Sound-side Limb Loading
Crossover Foot, Comfortable Walking Speed
|
1.07 Ratio (Newtons/body weight)
|
1.17 Ratio (Newtons/body weight)
|
|
Peak Sound-side Limb Loading
Energy Storing Foot, Comfortable Walking Speed
|
1.23 Ratio (Newtons/body weight)
|
1.29 Ratio (Newtons/body weight)
|
|
Peak Sound-side Limb Loading
Crossover Foot, Fast Walking Speed
|
1.37 Ratio (Newtons/body weight)
|
1.53 Ratio (Newtons/body weight)
|
|
Peak Sound-side Limb Loading
Energy Storing Foot, Fast Walking Speed
|
1.43 Ratio (Newtons/body weight)
|
1.45 Ratio (Newtons/body weight)
|
SECONDARY outcome
Timeframe: Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2)At the end of the study, participants will engage in a preference questionnaire with open-ended follow-up questions to elicit preferences and experiences with both feet. Questions will ask about overall preference, and preference for a range of mobility activities (e.g., "Which foot did you prefer overall, and why?" and "Which foot did you prefer for walking up stairs, and why?").
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Preference Questionnaire
Walking over uneven terrain · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking over uneven terrain · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking over uneven terrain · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing up from a chair · Prefers Crossover Foot
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing up from a chair · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing up from a chair · No preference
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Standing up from a chair · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Sitting down in a chair · Prefers Crossover Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Sitting down in a chair · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Sitting down in a chair · No preference
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Sitting down in a chair · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Turning on the prosthetic side · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Turning on the prosthetic side · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Turning on the prosthetic side · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Turning on the prosthetic side · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Getting in and out of a car · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Getting in and out of a car · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Getting in and out of a car · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Getting in and out of a car · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Playing sports · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Playing sports · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Playing sports · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Playing sports · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing for long periods · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Standing for long periods · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on inclines · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking on inclines · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on inclines · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on inclines · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing for long periods · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Standing for long periods · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on declines · Prefers Crossover Foot
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on declines · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in sand · Prefers Crossover Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in sand · Prefers Energy Storing Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking in sand · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in sand · Not applicable
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when you can't see your feet · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking when you can't see your feet · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when you can't see your feet · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when you can't see your feet · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when carrying a heavy load · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking when carrying a heavy load · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when carrying a heavy load · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking when carrying a heavy load · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in small spaces · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking in small spaces · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in small spaces · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking in small spaces · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Dancing · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Dancing · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Dancing · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Dancing · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Riding a bicycle · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Riding a bicycle · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Riding a bicycle · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Riding a bicycle · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking on declines · No preference
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking on declines · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Ascending stairs · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Ascending stairs · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Ascending stairs · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Ascending stairs · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Descending stairs · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Descending stairs · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Descending stairs · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Descending stairs · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking slowly · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking slowly · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking slowly · No preference
|
1 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking slowly · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking quickly · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Walking quickly · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking quickly · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking quickly · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Running · Prefers Crossover Foot
|
1 Participants
|
1 Participants
|
|
Preference Questionnaire
Running · Prefers Energy Storing Foot
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Running · No preference
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Running · Not applicable
|
0 Participants
|
0 Participants
|
|
Preference Questionnaire
Walking over uneven terrain · Prefers Crossover Foot
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)Self-reported measure of mobility, the PLUS-M 12-item Short Form is a single measure, scores range from 17.5-76.6, higher scores represent better mobility.
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2
Crossover Foot
|
64.5 score on a scale
|
71.4 score on a scale
|
|
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2
Energy Storing Foot
|
64.5 score on a scale
|
62.5 score on a scale
|
SECONDARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Change in Activities-Specific Balance Confidence Scale (ABC)
Crossover Foot
|
3.53 score on a scale
|
4 score on a scale
|
|
Change in Activities-Specific Balance Confidence Scale (ABC)
Energy Storing Foot
|
3.63 score on a scale
|
4 score on a scale
|
SECONDARY outcome
Timeframe: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)
Outcome measures
| Measure |
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
n=1 Participants
First intervention was crossover foot, second was energy storing foot
|
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
n=1 Participants
First intervention was energy storing foot, second was crossover foot
|
|---|---|---|
|
Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction
Crossover Foot
|
0.33 score on a scale
|
2 score on a scale
|
|
Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction
Energy Storing Foot
|
1 score on a scale
|
1 score on a scale
|
Adverse Events
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foot 1: Energy Storing Foot, Foot 2: Crossover 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place