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OpenTrials
Completed

NCT Number: NCT04641845

The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation

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.

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Key information

Conditions

Lower Limb Amputation Below Knee (Injury) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • had their prosthesis for at least one year (participants with a TTA)

Exclusion criteria

  • (other) neurological or orthopaedic impairments affecting walking ability
  • surgery on the lower extremities within the last six months
  • the use of a walking aid

Treatment and study plan

Cork inlay wedge

Other

Primary outcomes

  1. Symmetry of the centre of pressure velocity (VCOP symmetry)

    Time frame: On average, during 10 minutes.

    Symmetry of the VCOP trajectories during the stance phase of gait between the prosthetic leg and sound leg (participants with TTA), or the right and left leg (healthy individuals), calculated with the root mean square.

Secondary outcomes

  1. Step length symmetry

    Time frame: On average, during 10 minutes

    Ratio index of step length between left and right leg.

  2. Single leg stance time symmetry

    Time frame: On average, during 10 minutes

    Ratio index of single leg stance time between left and right leg.

  3. Double limb support symmetry

    Time frame: On average, during 10 minutes

    Ratio index of percentage of double limb support between left and right leg (Xright/(Xright+Xleft).

  4. Experienced walking comfort

    Time frame: On average, at 2.5 minutes, 5 minutes, 7.5 minutes and 10 minutes.

    Experienced walking comfort is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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