Lower Limb Amputation Below Knee (Injury)NCT04641845
The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation
A study testing Cork inlay wedge in people with Lower Limb Amputation Below Knee (Injury), run by Sint Maartenskliniek.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Cork inlay wedge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- had their prosthesis for at least one year (participants with a TTA)
Who cannot join
- (other) neurological or orthopaedic impairments affecting walking ability
- surgery on the lower extremities within the last six months
- the use of a walking aid
About this study
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.
Read the 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.
- Being tested
- Cork inlay wedge
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cork inlay wedgeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cork inlay wedge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On average, during 10 minutes.
Secondary outcomes (4)
Step length symmetry
Ratio index of step length between left and right leg.
Measured: On average, during 10 minutes
Single leg stance time symmetry
Ratio index of single leg stance time between left and right leg.
Measured: 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).
Measured: 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).
Measured: On average, at 2.5 minutes, 5 minutes, 7.5 minutes and 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Dec 2016
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental repeated measures study
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël LW Keijsers, PhD, Study chair, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641845
- Sponsor's protocol ID
- 638_Heel Height Amputation
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation
- ClinicalTrials.gov ID
- NCT04641845
- Acronym / sponsor ID
- 638_Heel Height Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental repeated measures study
| Arm | Type | Receives |
|---|---|---|
| Heel height increases | Experimental | Other: Cork inlay wedgeAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- had their prosthesis for at least one year (participants with a TTA)
Key exclusion criteria (3 listed)
- (other) neurological or orthopaedic impairments affecting walking ability
- surgery on the lower extremities within the last six months
- the use of a walking aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cork inlay wedge | Other | Heel height increases |
Primary outcome
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.
4 secondary outcomes
Step length symmetry
Time frame: On average, during 10 minutes
Single leg stance time symmetry
Time frame: On average, during 10 minutes
Double limb support symmetry
Time frame: On average, during 10 minutes
Experienced walking comfort
Time frame: On average, at 2.5 minutes, 5 minutes, 7.5 minutes and 10 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Lower Limb Amputation Below Knee (Injury)
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Recruiting
Restoration of Normative Postural Control
Lower Limb Amputation Below Knee (Injury)
Recruiting
Prosthetic Performance Enhancement Trial
Amputation, Lower Limb Amputation Below Knee (Injury)
Active, not recruitingObservational study
C-STAR Movement Database
Stroke, Parkinson Disease
Recruiting
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noël LW Keijsers, PhD study chair
Sint Maartenskliniek
Questions about this trial
What is this clinical trial studying?
A study testing Cork inlay wedge in people with Lower Limb Amputation Below Knee (Injury), run by Sint Maartenskliniek.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symmetry of the centre of pressure velocity (VCOP symmetry) (time frame: On average, during 10 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.