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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation Below Knee (Injury)
• Intervention / Treatment: Other: Cork inlay wedge

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Heel height increases; All participants consecutively walked with four heel height conditions (0 millimeter, 3 millimeter, 5 millimeter and 8 millimeter). The order of the heel height conditions was randomized.	Other: Cork inlay wedge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symmetry of the centre of pressure velocity (VCOP symmetry)	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.	On average, during 10 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length symmetry	Ratio index of step length between left and right leg.	On average, during 10 minutes
Single leg stance time symmetry	Ratio index of single leg stance time between left and right leg.	On average, during 10 minutes
Double limb support symmetry	Ratio index of percentage of double limb support between left and right leg (Xright/(Xright+Xleft).	On average, during 10 minutes
Experienced walking comfort	Experienced walking comfort is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).	On average, at 2.5 minutes, 5 minutes, 7.5 minutes and 10 minutes.

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 638_Heel Height Amputation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No