Microprocessor Knees in Early Rehabilitation

Amputation Clinical Trial

Official title:

Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433300
• Other study ID #: STUDY00003524
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: September 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury.

The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older, Unilateral transfemoral amputation, Between 4-16 weeks post amputation, Deemed ready for prosthetic fitting by a physician, No current or prior transfemoral prosthetic use, Able to read, write and communicate in English, Weight 125kg (275lbs) or less

Exclusion Criteria:

• Diagnosis of health condition (i.e. advanced cardiac disease, severe or end-stage pulmonary disease or severe dementia) that prevents safe prosthesis use or community ambulation with prosthesis, Weight greater than 125kg (275lbs)

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Ottobock Kenevo/C-Leg
Microprocessor-controlled prosthetic knee
• Ottobock 3R60/3R62
Nonmicroprocessor-controlled knee

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Otto Bock Healthcare Products GmbH, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic Limb Users Survey of Mobility	Self-reported prosthetic mobility	Monthly for 3 months
Secondary	Fall frequency	Number of falls while using the prosthesis	Monthly for 3 months
Secondary	Daily step count	Walking activity measured with StepWatch Monitor	Average daily step count by month for 3 months
Secondary	Timed up and go	Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.	Monthly for 3 months
Secondary	Amputee Mobility Predictor (AMPPro) Assessment Tool	The name of this tool is the Amputee Mobility Predictor (AMPPro) and it was developed by Robert Gailey, PhD, PT (https://www.sralab.org/rehabilitation-measures/amputee-mobility-predictor-0). The AMPPro assesses performance-based mobility for people who use prosthetic limbs. Example items include standing balance, ability to vary cadence, and ability to step over an obstacle.	Monthly for 3 months
Secondary	Six-minute walk test	Evaluates distance walked over 6 minute time frame with rest as needed	Monthly for 3 months
Secondary	Gait quality	GaitRite System, pressure sensitive instrumented walkway will collect average walking speed, step width, step time asymmetry during 6 minute walk test	Monthly for 3 months
Secondary	Activities-Specific Balance Confidence Scale (ABC)	The Activities-Specific Balance Confidence Scale (ABC) measures the construct of balance confidence. The 16-item ABC survey asks respondents to rate their confidence in performing a variety of activities without becoming unstable (e.g., walking in the home, walking on a ramp, walking in crowds). Response options range from "no confidence" to "completely confident" when performing the activity. The revised scale proposed by Sakakibara (2011) will be used to calculate a total balance confidence score; scores for participants will range from 0 (low balance confidence) to 4 (high balance confidence).	Baseline and monthly for 3 months
Secondary	Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0	Self-reported measure of Physical Function, satisfaction with social roles, fatigue, sleep disturbance, pain intensity, pain interference, anxiety and depression	Baseline and monthly for 3 months
Secondary	Reintegration to Normal Living Index (RNLI)	11 item questionnaire to assess self-reported physical, social and psychologic performance following injury	Baseline and monthly for 3 months