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

NCT04641845 | Completed

• 1 other identifier: 638_Heel Height Amputation
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Step length symmetry

  On average, during 10 minutes

• Single leg stance time symmetry

  On average, during 10 minutes

• Double limb support symmetry

  On average, during 10 minutes

• Experienced walking comfort

  On average, at 2.5 minutes, 5 minutes, 7.5 minutes and 10 minutes.

Study Arms (1)

Heel height increases

EXPERIMENTAL

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

Interventions

Cork inlay wedge OTHER

Heel height increases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sint Maartenskliniek: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Noël LW Keijsers, PhD

  Sint Maartenskliniek

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental repeated measures study

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 24, 2020
• Study Start: December 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share