AmputationNCT03433300
Microprocessor Knees in Early Rehabilitation
A study testing Ottobock Kenevo/C-Leg and Ottobock 3R60/3R62 in people with Amputation, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Ottobock Kenevo/C-Leg and Ottobock 3R60/3R62
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?
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.
- Conditions
- Amputation
- Being tested
- Ottobock Kenevo/C-Leg, Ottobock 3R60/3R62
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ottobock Kenevo/C-LegDevice
Microprocessor-controlled prosthetic knee
Ottobock 3R60/3R62Device
Nonmicroprocessor-controlled knee
| Study group | Role | What they receive |
|---|---|---|
| Microprocessor Knee | Experimental | Ottobock Kenevo/Ottobock C-Leg Receives: Device: Ottobock Kenevo/C-Leg |
| Nonmicroprocessor knee | Active comparator | Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants. Receives: Device: Ottobock 3R60/3R62 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Limb Users Survey of Mobility
Self-reported prosthetic mobility
Measured: Monthly for 3 months
Secondary outcomes (9)
Fall frequency
Number of falls while using the prosthesis
Measured: Monthly for 3 months
Daily step count
Walking activity measured with StepWatch Monitor
Measured: Average daily step count by month for 3 months
Timed up and go
Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position.
Measured: Monthly for 3 months
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.
Measured: Monthly for 3 months
Six-minute walk test
Evaluates distance walked over 6 minute time frame with rest as needed
Measured: Monthly for 3 months
Gait quality
GaitRite System, pressure sensitive instrumented walkway will collect average walking speed, step width, step time asymmetry during 6 minute walk test
Measured: Monthly for 3 months
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).
Measured: Baseline and monthly for 3 months
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
Measured: Baseline and monthly for 3 months
Reintegration to Normal Living Index (RNLI)
11 item questionnaire to assess self-reported physical, social and psychologic performance following injury
Measured: Baseline and monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start13 Apr 2018
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Otto Bock Healthcare Products GmbH
- Responsible party
- Principal investigator, Sara Morgan, University of Washington
- Investigators
- Sara J Morgan, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433300
- Sponsor's protocol ID
- STUDY00003524
- Status last verified
- Sep 2020
- First submitted
- 8 Feb 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?
- ClinicalTrials.gov ID
- NCT03433300
- Acronym / sponsor ID
- STUDY00003524
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense, Otto Bock Healthcare Products GmbH
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Microprocessor Knee | Experimental | Device: Ottobock Kenevo/C-LegOttobock Kenevo/Ottobock C-Leg |
| Nonmicroprocessor knee | Active comparator | Device: Ottobock 3R60/3R62Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ottobock Kenevo/C-LegMicroprocessor-controlled prosthetic knee | Device | Microprocessor Knee |
| Ottobock 3R60/3R62Nonmicroprocessor-controlled knee | Device | Nonmicroprocessor knee |
Primary outcome
Prosthetic Limb Users Survey of Mobility
Time frame: Monthly for 3 months
Self-reported prosthetic mobility
9 secondary outcomes
Fall frequency
Time frame: Monthly for 3 months
Daily step count
Time frame: Average daily step count by month for 3 months
Timed up and go
Time frame: Monthly for 3 months
Amputee Mobility Predictor (AMPPro) Assessment Tool
Time frame: Monthly for 3 months
Six-minute walk test
Time frame: Monthly for 3 months
Gait quality
Time frame: Monthly for 3 months
Activities-Specific Balance Confidence Scale (ABC)
Time frame: Baseline and monthly for 3 months
Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0
Time frame: Baseline and monthly for 3 months
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline and monthly for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J Morgan, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ottobock Kenevo/C-Leg and Ottobock 3R60/3R62 in people with Amputation, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Limb Users Survey of Mobility (time frame: Monthly for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.