## Protocol Section
### Identification Module
**NCT ID:** NCT06419920

**Acronym:** PROSPER

**Brief Title:** Prosthetic Performance Enhancement Trial

**Official Title:** Prosthetic Performance Enhancement Trial

#### Organization Study ID Info
**ID:** UNLV-2023-595
#### Organization
**Class:** OTHER
**Full Name:** University of Nevada, Las Vegas
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Nevada, Las Vegas

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

**Detailed Description:** Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.

Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.

The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.

### Conditions Module

**Conditions:**

- Amputation

- Lower Limb Amputation Below Knee (Injury)

- Lower Limb Amputation Above Knee (Injury)

- Lower Limb Amputation at Ankle (Injury)

- Lower Limb Amputation Knee

- Lower Limb Amputation at Hip (Injury)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Feasibility study incorporating a single-blinded Phase I clinical trial with a parallel groups design, involving two treatment conditions: uneven terrain training (UT) and flat terrain (FT) training. Participants will be allocated randomly to UT and FT arms in a 3:1 ratio.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 35

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Walking on a standard, flat treadmill or mat.

**Intervention Names:**

- Other: Flat terrain locomotor training

**Label:** Flat terrain training

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Walking on an uneven terrain treadmill or mat.

**Intervention Names:**

- Other: Uneven terrain locomotor training

**Label:** Uneven terrain training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Flat terrain training

**Description:** The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.

**Name:** Flat terrain locomotor training

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Uneven terrain training

**Description:** The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.

**Name:** Uneven terrain locomotor training

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of planned sessions attended, per participant.

**Measure:** Session adherence

**Time Frame:** Through study completion, over 4 weeks

#### Secondary Outcomes

**Description:** Time to complete L-test, in s. Participant rises from a chair and guided by cones, walks 10m forward, turns 90 degrees, walks a further 10m, turns 180 degrees, then follows the same path back to the chair and sits. Result from a single test following one practice trial is recorded.

**Measure:** L-test time

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** 16-item self report measure recording confidence in performing activities during daily life that require balance, on numerical ratings scale, recorded as a percentage (out of 100).

**Measure:** Activities-specific Balance Confidence Scale summary score

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** Mean number of steps per day over 7 days, collected using ankle worn activity monitor.

**Measure:** Average daily activity

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** Time to complete forwards, lateral and backwards stepping pattern, in s.

**Measure:** Four Square Step Test time

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** Distance traveled along a narrow beam, in m. Participants traverse a 3.66 m narrow beam. The distance traveled until the participant places a foot on the ground is measured. The mean of the final three of five trials is recorded.

**Measure:** Beam walking distance

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** Walking distance traveled in two minutes, in m.

**Measure:** Two-minute walk test distance

**Time Frame:** Pre-intervention, within 5 days post intervention

**Description:** Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.

**Measure:** Protocol acceptability

**Time Frame:** End of intervention week 4

**Description:** Number of participants recruited within one year

**Measure:** Recruitment feasibility - recruitment rate

**Time Frame:** From start of recruitment period, to 12 month time point.

**Description:** Number of clinics from which at least one participant is recruited.

**Measure:** Recruitment feasibility - participating clinics

**Time Frame:** Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.

**Description:** Sample characteristics of all participants enrolled in the study, regardless of completion.

**Measure:** Recruitment feasibility - sample characteristics

**Time Frame:** Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.

**Description:** Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data.

**Measure:** Activity data evaluation

**Time Frame:** Throughout activity monitoring period, over 2 weeks

**Description:** Medial-lateral trunk variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of peak per-step lateral trunk velocity during UT walking sessions relative to that of overground walking, in m/s.

**Measure:** Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking

**Time Frame:** Through study completion, over 4 weeks

**Description:** Terrain contour depth at which the maximum relative variability was recorded, in m.

**Measure:** Contour depth at maximum relative variability

**Time Frame:** Through study completion, over 4 weeks

**Description:** Step width variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of step width during UT walking sessions relative to that of overground walking, in m.

**Measure:** Maximum relative step width variability during uneven terrain in comparison to overground walking

**Time Frame:** Through study completion, over 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* lower limb amputation at ankle (Symes) level and above
* age 18+ years
* fitted with a walking prosthesis and use it regularly for home and/or community ambulation
* good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
* able to walk for three minutes at a time with or without an assistive device
* willing to travel to the University of Nevada Las Vegas, Maryland Campus, for all training and assessment sessions

Exclusion Criteria:

* leg/foot ulcer or other conditions that cause pain during weight-bearing
* poor skin integrity that could cause tissue breakdown by walking
* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
* unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
* pregnancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jenny.kent@unlv.edu

**Name:** Jenny A Kent, PhD, CSci

**Phone:** 7028955949

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Las Vegas

**Country:** United States

**Facility:** University of Nevada Las Vegas

**State:** Nevada

**Zip:** 89154

#### Overall Officials

**Official 1:**

**Affiliation:** University of Nevada, Las Vegas

**Name:** Jenny A Kent, PhD, CSci

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-31
