Determining the Potential Benefit of Powered Prostheses

NCT02828982 | Completed Results

• 1 other identifier: HUM00080734
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.

Conditions

Unilateral Traumatic Amputation; Amputation, Traumatic

Keywords

powered ankle prosthesis; activity monitoring; muscle fatigue; below knee amputation

Outcome Measures

Primary Outcomes (3)

• Metabolic Cost of Walking

  Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.

  Testing took place after wearing the prostheses for two weeks

• Total Steps Outside the Home Over a Two Week Period

  Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device

  2 weeks

• Quality of Life (QoL) on a Short-Form 36

  Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  Questionnaire completed 2 weeks after wearing each prosthesis

Secondary Outcomes (3)

• Prosthetic Evaluation Questionnaire (PEQ)

  Questionnaire completed 2 weeks after wearing each prosthesis

• Muscle Activity in the Lower Limb

  Testing took place after the participant wore the prosthesis for 2 weeks

• Time to Fatigue

  Testing took place after wearing the prostheses for two weeks

Study Arms (2)

Powered Ankle Prosthesis

EXPERIMENTAL

In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks.

Device: Powered ankle prosthesis

Dynamic Response Foot

SHAM COMPARATOR

In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long.

Device: Dynamic Response Foot

Interventions

Powered ankle prosthesis DEVICE

This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.

Powered Ankle Prosthesis

Dynamic Response Foot DEVICE

This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.

Dynamic Response Foot

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes

You may not qualify if:

• History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time

Sponsors & Collaborators

• Deanna H Gates: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2.

  PMID: 33726802 DERIVED

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. Deanna Gates
• Organization: University of Michigan

gatesd@umich.edu

(734) 647-2698

Study Officials

• Deanna H Gates, Ph.D.

  University of Michigan

  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: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 18, 2022
• Results First Posted: November 13, 2020

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)