AmputationNCT04759014
The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2021to 1 Jul 2021
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fourty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Only participants using active vacuum-assisted suspension system will be included in the study in order to prevent any bias from suspansion system on the results.
Who may be able to join
- aged 18-65 years
- Medicare functional classification level K4 (very active)
- using the prosthesis for at least 6 months and at least 6 hrs a day
- using active vacuum-assisted suspension system
Who cannot join
- bilateral amputation,
- the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital
Ankara
About this study
Official title: The Effect of Using Two Different Prosthetic Feet on Functional Capacity, Pain Severity, Satisfaction Level and Quality of Life in High Activity Patients With Unilateral Transtibial Amputation
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.
Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.
Read the detailed description
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.
Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.
Methods: Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Functional capacity will be evaluated using the six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS. The QoL of each patient will be assessed using the Short Form 36 (SF-36).
- Conditions
- Amputation
- Being tested
- The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
- Keywords
- Transtibial amputation, Prosthetic foot, Functional capacity, Satisfaction, Quality of life
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of lifeOther
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 21 patients using non-articulated dynamic foot (non-articulating ankle, NAA) Receives: Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life | |
| Group 2 | 21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) Receives: Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).
Measured: through study completion, an average of one and a half months
Short Form 36 (SF-36)
The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL.
Measured: through study completion, an average of one and a half months
The six-minute walking test (6MWT)
Functional capacity will be evaluated using the six-minute walking test (6MWT). The 6MWT evaluates walking function and endurance. Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path. The 6MWT is both valid and reliable among individuals with lower-limb loss.
Measured: through study completion, an average of one and a half months
Secondary outcomes (1)
Likert scale
Level of difficulty experienced during walking on straight road, walking uneven road, ascending stairs, descending stairs, ascending ramps and descending ramps will be recorded on a 5-point Likert scale ((1) very easy, (2) easy , (3) neutral, (4) difficult, (5) very difficult).
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start18 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Merve Orucu Atar, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759014
- Sponsor's protocol ID
- 11
- Status last verified
- Nov 2021
- First submitted
- 13 Feb 2021
- Last updated
- 23 Nov 2021
- Results posted
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Two Different Prosthetic Feet on Functional Capacity, Pain Severity, Satisfaction Level and Quality of Life in High Activity Patients With Unilateral Transtibial Amputation
- ClinicalTrials.gov ID
- NCT04759014
- Acronym / sponsor ID
- 11
- Conditions
- Amputation
- Keywords
- Transtibial amputation, Prosthetic foot, Functional capacity, Satisfaction, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 Feb 2021 (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.
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.
Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.
Detailed description
Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.
Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.
Methods: Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Functional capacity will be evaluated using the six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS. The QoL of each patient will be assessed using the Short Form 36 (SF-36).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life21 patients using non-articulated dynamic foot (non-articulating ankle, NAA) |
| Group 2 | – | Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fourty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Only participants using active vacuum-assisted suspension system will be included in the study in order to prevent any bias from suspansion system on the results.
Key inclusion criteria (4 listed)
- aged 18-65 years
- Medicare functional classification level K4 (very active)
- using the prosthesis for at least 6 months and at least 6 hrs a day
- using active vacuum-assisted suspension system
Key exclusion criteria (2 listed)
- bilateral amputation,
- the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
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 |
|---|---|---|
| The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of lifeThe effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life | Other | Group 1, Group 2 |
Primary outcome
Visual Analogue Scale
Time frame: through study completion, an average of one and a half months
All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).
Short Form 36 (SF-36)
Time frame: through study completion, an average of one and a half months
The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL.
The six-minute walking test (6MWT)
Time frame: through study completion, an average of one and a half months
Functional capacity will be evaluated using the six-minute walking test (6MWT). The 6MWT evaluates walking function and endurance. Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path. The 6MWT is both valid and reliable among individuals with lower-limb loss.
1 secondary outcome
Likert scale
Time frame: through study completion, an average of one and a half months
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 23 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Merve Orucu Atar, MD principal investigator
Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Visual Analogue Scale (time frame: through study completion, an average of one and a half months). The study lists 3 primary outcomes in all. 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 23 Nov 2021.