N/A
N=8
EmPOWERing Active Seniors With Energy
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT02958553 ↗Enrolled (actual)
8
Serious AEs
16.7%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT) — 1; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- emPOWER Ankle (Device); Subject's own passive prosthesis (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otto Bock Healthcare Products GmbH
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT) |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT) |
2; 2; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT) |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test |
0; 4; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test |
0; 2; 2 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment |
0; 4; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form) |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS) |
1; 0; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS) |
2; 1; 1 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods) |
0; 1; 2 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function |
2; 2; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a) |
1; 3; 0 | — |
| SECONDARY Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a) |
1; 3; 0 | — |
Summary
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
Eligibility Criteria
Inclusion Criteria
- Males and females
- 55 years or older
- Subjects with transtibial amputations of either leg at least 1 year prior
- Suction or elevated vacuum suspension and Socket Comfort Score of at least 6
- Sock fluctuation of ≤ 8 ply per day
- K-level rating of 3 or 4 based on the Amputee Mobility Predictor Assessment Tool
- Ability to walk at a walking speed of > 0.75 meters per second
- Unilateral amputees (up to 7 bilateral amputees can be included, 1 per site in addition to the unilateral amputees who will be analyzed as a separate sub group)
- Foot size: 25-30 cm
- Ability to complete a continuous 6-Minute Walk Test
- Ability to provide written, informed consent
- Ability to complete study visits and study documents
- Ability to manage the complexity of a powered device including charging and changing batteries as needed
- Ability to read and understand English
Exclusion Criteria
- Subjects who have never used a prosthetic device
- Less than 55 years of age
- Weight 287 lbs.
- Transfemoral amputees
- Active sores or ulceration on subject's residual limb
- Sore on contralateral foot.
- Cuff-link socket suspension
- Socket Comfort Score less than 6
- Sock fluctuation of > 8 per day
- K level of 1 or 2
- Amputation clearance < 8.625"
- History of stroke or TIA that impairs current walking
- Recent history of excessive falling defined as more than 2 falls requiring medical assistance in the prior year
- Medications potentially affecting balance
- Recent hospitalization (within past 3 months)
- Cognitive deficiency that would impact ability to charge and change batteries as needed
Data sourced from ClinicalTrials.gov (NCT02958553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.