Evaluation of a Modified Running-specific Prosthetic Foot

NCT02440711 | Completed Results

• 1 other identifier: 49150
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.

Conditions

Transtibial Amputation

Outcome Measures

Primary Outcomes (14)

• Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation

  Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation

  Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Six-minute Walk Test (6MWT), Participants With Unilateral Amputation

  Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Six-minute Walk Test (6MWT), Participants With Bilateral Amputation

  Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Borg Rating of Perceived Exertion (CR100), Participants With Unilateral Amputation

  Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Borg Rating of Perceived Exertion (CR100), Participants With Bilateral Amputation

  Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Walking Speed, Participants With Unilateral Amputation

  Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).

  Participants were tested after using each foot in their prosthesis for 1 month.

• Walking Speed, Participants With Bilateral Amputation

  Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Width, Participants With Unilateral Amputation

  Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Width, Participants With Bilateral Amputation

  Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Length, Participants With Unilateral Amputation

  Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Length, Participants With Bilateral Amputation

  Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Time, Participants With Unilateral Amputation

  Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.

  Participants were tested after using each foot in their prosthesis for 1 month.

• Step Time, Participants With Bilateral Amputation

  Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.

  Participants were tested after using each foot in their prosthesis for 1 month.

Secondary Outcomes (10)

• Daily Step Activity, Participants With Unilateral Amputation

  Participants' step count data from the 2 weeks prior to in-person testing.

• Daily Step Activity, Participants With Bilateral Amputation

  Participants' step count data from the 2 weeks prior to in-person testing.

• Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Unilateral Amputation

  Participants were tested after using each foot in their prosthesis for 1 month.

• Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Bilateral Amputation

  Participants were tested after using each foot in their prosthesis for 1 month.

• Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Unilateral Amputation

  Participants were tested after using each foot in their prosthesis for 1 month.

Study Arms (2)

mRSF-ESF

EXPERIMENTAL

Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.

Device: Energy storing foot (ESF); Device: Modified running specific foot (mRSF)

ESF-mRSF

EXPERIMENTAL

Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.

Device: Energy storing foot (ESF); Device: Modified running specific foot (mRSF)

Interventions

Energy storing foot (ESF) DEVICE

A commercially-available energy storing prosthetic foot

Also known as: Ossur Vari-flex

ESF-mRSF; mRSF-ESF

Modified running specific foot (mRSF) DEVICE

A running specific prosthetic foot customized for both running and walking activities

Also known as: Ossur Cheetah (modified); Ossur Xplore

ESF-mRSF; mRSF-ESF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral or bilateral, transtibial (below-knee) amputation from non-dysvascular causes
• Medicare functional classification level (K-level) 3 or higher (unlimited community ambulatory)
• prosthetic user for \> 1 year
• scheduled to receive a mRSF prosthesis
• able and willing to participate in the study protocol (e.g., treadmill walking, overground walking, respond to survey questions, able to read and write English)

You may not qualify if:

• contralateral lower or upper limb involvement
• any health condition that would limit participation in the study procedures (e.g., skin breakdown, heart disease)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.

  PMID: 29414988 DERIVED

Results Point of Contact

• Title: Dr. Brian Hafner
• Organization: University of Washington

bhafner@uw.edu

206-685-0214

Study Officials

• Brian Hafner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-07

Locations

US (1)