Trial Outcomes & Findings for Assessing the DSR Ankle (NCT NCT05955378)

NCT ID: NCT05955378

Last Updated: 2025-07-01

Results Overview

Minimum foot clearance is the shortest distance between the foot and the ground during swing, and it occurs approximately halfway through the swing phase of gait.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: after up to 3 weeks of training
• Results posted on: 2025-07-01

Participant Flow

5 patients were enrolled between August 22, 2023 and November 19, 2024 at the Shirley Ryan AbilityLab in Chicago, IL.

3 of 5 patients completed this cross-over study.

Participant milestones

Measure	Predicate Ankle, Then DSR Ankle Participants first performed assessments with their predicate (daily use) prosthetic ankle. After a washout period of at least 2 weeks, they were trained and assessed with the DSR Ankle. The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation.	DSR Ankle, Then Predicate Ankle Participants first performed assessments with the DSR Ankle. The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. After a washout period of at least 2 weeks, they were trained and assessed with their predicate (daily use) prosthetic ankle.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Predicate Ankle, Then DSR Ankle n=2 Participants Participants first performed assessments with their predicate (daily use) prosthetic ankle. After a washout period of at least 2 weeks, they were trained and assessed with the DSR Ankle. The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation.	DSR Ankle, Then Predicate Ankle n=1 Participants Participants first performed assessments with the DSR Ankle. The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. After a washout period of at least 2 weeks, they were trained and assessed with their predicate (daily use) prosthetic ankle.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=2 Participants	1 Participants n=1 Participants	1 Participants n=3 Participants
Age, Categorical >=65 years	2 Participants n=2 Participants	0 Participants n=1 Participants	2 Participants n=3 Participants
Age, Continuous	82 years STANDARD_DEVIATION 2.8 • n=2 Participants	59 years STANDARD_DEVIATION 0 • n=1 Participants	74.3 years STANDARD_DEVIATION 13.4 • n=3 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	1 Participants n=1 Participants	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	1 participants n=1 Participants	3 participants n=3 Participants

PRIMARY outcome

Timeframe: after up to 3 weeks of training

Minimum foot clearance is the shortest distance between the foot and the ground during swing, and it occurs approximately halfway through the swing phase of gait.

Outcome measures

Measure	DSR Ankle n=3 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=3 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Minimum Foot Clearance	4.07 centimeters Standard Deviation 0.96	3.87 centimeters Standard Deviation 1.11

PRIMARY outcome

Timeframe: after up to 3 weeks of training

Time to foot flat is the duration of time between initial contact at heel strike and the full contact of the sole of the foot on the ground in stance.

Outcome measures

Measure	DSR Ankle n=3 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=3 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Time to Foot Flat	0.31 seconds Standard Deviation 0.13	0.27 seconds Standard Deviation 0.19

SECONDARY outcome

Timeframe: after up to 3 weeks of training

The OPUS is a self-report questionnaire consisting of 5 modules. It can be used for prosthetic and orthotic programs for quality assessment, to maintain awareness of improvement in activities, to evaluate changes in patient's functional status and quality of life, and to assess satisfaction with devices and services. The Device Satisfaction module uses a 5-point Likert scale (1 to 5), with a total score range of 11 to 55. Higher values indicate higher levels of satisfaction.

Outcome measures

Measure	DSR Ankle n=2 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=2 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Orthotics Prosthetics User Survey (OPUS) Device Satisfaction	45 units on a scale Standard Deviation 5.66	44.5 units on a scale Standard Deviation 3.54

SECONDARY outcome

Timeframe: after up to 3 weeks of training

The 10 MWT assesses walking speed in meters per second over a distance of 10 meters.

Outcome measures

Measure	DSR Ankle n=3 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=2 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
10 Meter Walk Test (10 MWT)	0.41 meters per second Standard Deviation 0.28	0.53 meters per second Standard Deviation 0.29

SECONDARY outcome

Timeframe: after up to 3 weeks of training

The 6 MWT assesses walking distance in meters over a period of 6 minutes.

Outcome measures

Measure	DSR Ankle n=2 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=2 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Six Minute Walk Test (6 MWT)	145.1 meters Standard Deviation 121.48	162.9 meters Standard Deviation 142.84

SECONDARY outcome

Timeframe: after up to 3 weeks of training

The TUG assesses mobility, balance, walking ability, and fall risk in older adults.

Outcome measures

Measure	DSR Ankle n=2 Participants The DSR Ankle is a novel microprocessor-controlled ankle prosthesis that is able to provide enhanced mobility and stability to individuals with lower limb amputation. It interfaces to the user by attaching to their socket via an industry-standard pyramid connector. DSR Ankle: This is the experimental ankle component used in the overall prosthetic intervention.	Predicate Ankle n=2 Participants The predicate ankle is the user's prescribed prosthesis worn for the activities of daily living. Predicate Ankle: This is the participant's prescribed ankle/foot complex used in the overall prosthetic intervention.
Timed Up and Go (TUG)	42.17 seconds Standard Deviation 26.16	23.13 seconds Standard Deviation 14.87

Adverse Events

DSR Ankle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Predicate Ankle

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

Arun Jayaraman

Shirley Ryan AbilityLab

Phone: 312-238-6875

Email: ajayaraman@sralab.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place