NCT04275973

Evaluating Mobility Interventions in the Real World

Completed NA Results posted Last updated 19 December 2025

What this trial tests

NA trial testing Lower limb prostheses in Lower Limb Amputation in 20 participants. Completed in 1 August 2024.

Timeline

3 September 2021

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	20
Start date	3 September 2021
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Lower limb prostheses
• Orthoses for Drop-foot

Conditions studied

• Lower Limb Amputation — all drugs for Lower Limb Amputation →
• Drop Foot — all drugs for Drop Foot →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 75, any sex, with Lower Limb Amputation or Drop Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Minimum Foot Clearance With Different Prostheses Primary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.02117	± 0.005247

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.01976	± 0.007828

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.01932	± 0.004138

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.03055	± 0.001360

Minimum Foot Clearance With Different Orthoses Primary · Baseline, 10 days, and 20 days for Orthotic interventions

Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study.

No Intervention

Group	Value	95% CI
Orthoses User With Drop-foot	0.56469	± 0.662561

Ankle Foot Orthosis

Group	Value	95% CI
Orthoses User With Drop-foot	0.721081	± 0.857378

Functional Electrical Stimulation Device

Group	Value	95% CI
Orthoses User With Drop-foot	0.81136	± 1.105746

Behavioral Gait Function as Measured From Daily Stride Count Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Behavioral gait function will be measured by daily stride count (strides per sensor hour, Prosthetics only), participants crossed over to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	264.9	± 177.0

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	245.7	± 113.1

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	230.9	± 117.8

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	269.3	± 92.49

Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Behavioral gait function will be measured by average stride speed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

less than 10 seconds

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.4685	± 0.049

10 to 30 seconds

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.7155	± 0.0936

30-60 seconds

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.906	± 0.1172

60-120 seconds

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.9652	± 0.1562

greater than 120 seconds

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	1.0486	± 0.1979

Prosthetic Limb Users Survey of Mobility Score Secondary · up to 12 weeks

The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a 12 item questionnaire. It is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M instruments measure prosthetic users' mobility (i.e., the ability to move intentionally and independently from one place to another). PLUS-M questions assess respondents' perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. The described activities relate to two primary forms of movement, locomotion (i.e., movement in a co

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	56.5	± 7.665246245

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	53.78	± 7.3123

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	53.83	± 7.898

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	47.4	± 5.444

Change in Movement Quality as Determined by Stride Width: Prosthesis Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Change in movement quality will be determined by stride width, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.1328	± 0.03138

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.1417	± 0.05243

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.11526455	± 0.02398894

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.1202	± 0.04510

Change in Movement Quality as Determined by Stride Width: Orthoses Secondary · Baseline, 10 days, and 20 days for Orthotic interventions

Change in movement quality will be determined by stride width, participants crossover to different conditions at different study visits, data collected up to 20 days on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.

No Intervention

Group	Value	95% CI
Orthoses User With Drop-foot	0.045	± 0.010

AFO: Sprystep

Group	Value	95% CI
Orthoses User With Drop-foot	0.045	± 0.010

FES: Bioness

Group	Value	95% CI
Orthoses User With Drop-foot	0.047	± 0.014

Change in Gait Performance as Determined by Average Speed Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Change in gait performance as determined by speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.8376	± 0.1332

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.8553	± 0.1149

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.8635	± 0.1444

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	0.9521	± 0.08561

Gait Performance as Determined by Stride Frequency at Identical Speed Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Gait performance as determined by stride frequency at identical speed (included strides with walking speeds between 0.75-1.25 meters per second). Participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	67.47	± 3.237

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	68.22	± 5.835

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	67.46	± 4.130

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	60.37	± 5.448

Change in Functional Gait Assessment Score Secondary · Baseline, 10 days, and 20 days for Orthotic interventions

The Functional Gait Assessment Score will be measured for the sub-population of participants with Multiple Sclerosis (MS). The total score ranges from 0-30 with higher scores indicating increased impairment in gait. Participants crossover to each of three conditions at different study visits.

No Intervention

Group	Value	95% CI
Orthoses User With Drop-foot	16.09	± 5.230

Ankle Foot Orthosis

Group	Value	95% CI
Orthoses User With Drop-foot	17.27	± 6.566

Functional Electrical Stimulation Device

Group	Value	95% CI
Orthoses User With Drop-foot	18.45	± 5.298

Change in 6 Minute Walking Test Distance Secondary · Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions

The sub-population of participants with MS will undergo a 6 minute walking test for distance. Each participant will crossover to three conditions over three study visits: No intervention, the carbon fiber ankle foot orthosis (cfAFO), and a functional electrical stimulation (FES) device). Reported here are the difference from No intervention for the cfAFO and FES orthoses, a positive number shows an increase in distance walked due to the intervention.

No Intervention

Group	Value	95% CI
Orthoses User With Drop-foot	394.94	± 123.83

AFO: Sprystep

Group	Value	95% CI
Orthoses User With Drop-foot	426.73	± 117.87

FES: Bioness

Group	Value	95% CI
Orthoses User With Drop-foot	419.09	± 127.16

Stride Length at Identical Walking Speed Secondary · Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Walking speeds from 0.75 to 1.25 meters per second were analyzed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Low Profile Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	1.196	± 0.1434

Energy Storage and Return Foot

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	1.198	± 0.09409

Passive Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	1.200	± 0.1564

Microprocessor Hydraulic Ankle

Group	Value	95% CI
Prosthesis User With Transtibial or Transfemoral Amputation	1.302	± 0.1194

Sponsor's own description

This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study.

Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.