Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04641845 |
| Other study ID # |
638_Heel Height Amputation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2016 |
| Est. completion date |
May 1, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
Sint Maartenskliniek |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Prosthetic alignment is important for walking function and walking comfort in people with a
transtibial amputation (TTA). Prosthetic alignment is defined as the position of prosthetic
parts relative to the body and to each other. A suboptimal alignment decreases stability and
increases energy use during walking. Therefore, finding the optimal alignment is an important
aspect of rehabilitation. Shoe heel height is considered to influence prosthetic alignment,
walking comfort and gait symmetry in people with a TTA. Unfortunately, research on the effect
of heel height is scarce and no evidence is available on the effects of variations smaller
than 20 mm. However, these small heel height variations between store-bought shoes are often
overlooked by people with an amputation and may cause secondary musculoskeletal problems in
the long term. To increase the knowledge on this topic, this study aims to examine the
effects of small increases in heel height on gait symmetry in people with a TTA and healthy
individuals. It was expected that higher heel height would cause more asymmetry in gait and
lower walking comfort. People with a TTA were expected to be affected more by heel height
changes than healthy individuals.
Description:
Optimal prosthetic alignment is essential to achieve a functional gait pattern in people with
a transtibial amputation (TTA). A suboptimal alignment decreases stability, increases the
metabolic costs of walking, and increases the risk of secondary musculoskeletal and stump
problems. Prosthetic alignment is defined as the position of the prosthetic parts relative to
the body and to each other. Dynamic alignment of the prosthesis, especially the 'fine tuning'
of the prosthesis based on the patient's needs, is a continuous process during
rehabilitation.
Throughout the entire alignment process the prosthetists takes the shoe heel height of the
patient into account. Moreover, patients are advised to search for a similar heel height when
purchasing new shoes. However, prosthetic walkers frequently report complaints during their
follow-up visits with their prosthetist or rehabilitation physician that possibly are related
to prosthetic misalignment. Although several studies describe the effects of heel height on
gait in healthy individuals, our knowledge about the effects of heel height within the TTA
population is still limited to one study examining heel height changes of 20 millimeter. The
variation in heel height of commercially available shoes is often smaller, and therefore
easily overlooked by people with a TTA. Since it is not clear what the effects of smaller
heel height variations on the gait pattern are, additional research is needed to enable
prosthetists and therapists to better advise their patients.
Therefore, the primary objective was to examine the effect of small increases in heel height
on gait symmetry in people with a TTA. It was expected that a larger increase in heel height
would result in more gait asymmetry and lower walking comfort. In addition, healthy
individuals were included in whom smaller effects of the heel height changes were expected.
