Amputation, TraumaticNCT02934074
Relationship Between Gait Variability and Sensation
An observational study of Amputation, Traumatic, run by Hacettepe University.
Trial summary
Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Amputation, Traumatic
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Nov 2016
- How long will I take part?
- 20 Days
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals with traumatic lower limb loss
Who may be able to join
- Individuals with unilateral lower limb loss Traumatic limb loss Age between 20-55 years Using conventional type socket design Dynamic foot using
Who cannot join
- Have passive joint limitation at extremities Surgery at last 1 year Systemic problems such as neurologic disorders, rheumatoid disorders… Another orthopedic anomalies
About this study
Official title: Investigating the Relationship Between Gait Variability and Related Factors in Individuals With Lower Limb Loss
Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments
Read the detailed description
Twenty participants with lower limb loss who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, will be the subjects of this study.
Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 2nd and 4th minutes at walk. Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments.
- Conditions
- Amputation, Traumatic
- Being tested
- No intervention
- Keywords
- Limb Loss, Gait Variability, Phantom Sensation, Phantom Pain, Peripheral Sensation
- Medical subject headings
- Amputation, Traumatic, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Lower Limb Loss | Individuals with unilateral lower limb loss will be participants of the group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length variability assesment while walking.
Gait parameters (step length, variation of step length) will be evaluated with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 2nd and 4th minutes at walk.
Measured: Initially evaluation at first minute
Secondary outcomes (2)
Phantom sensation and phantom pain assessment
Phantom sensation and phantom pain will be asked as existence or not.
Measured: Initially evaluation at first minute
Sensory test
Sensorial loss will be evaluated with Semmes Weinstein Monofilaments (SWME) which is a noninvasive, inexpensive, rapid, and easy-to-apply test and often used in clinical routine assessment. The monofilaments will be applied to the stump along to the incision area and grafted skin area until the monofilaments bended for about one second. Participants will be instructed to say "yes" once they feel the monofilament on their skin. Each test will be repeated for 7 times whether the sensation loss was existed or not. Five true answers from 7 repeat will be accepted as normal feeling. Monofilament tests will beggin at 4.56 as known as protective sensation.
Measured: Initially evaluation at first minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934074
- Sponsor's protocol ID
- GO 16/344
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Gait Variability and Related Factors in Individuals With Lower Limb Loss
- ClinicalTrials.gov ID
- NCT02934074
- Acronym / sponsor ID
- GO 16/344
- Conditions
- Amputation, Traumatic
- Keywords
- Limb Loss, Gait Variability, Phantom Sensation, Phantom Pain, Peripheral Sensation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Twenty individuals who were referred to receive physiotherapy will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments
Detailed description
Twenty participants with lower limb loss who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, will be the subjects of this study.
Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 2nd and 4th minutes at walk. Phantom sensation and phantom pain will be asked as existence or not. Sensorial loss will evaluate with Semmes Weinstein Monofilaments.
Study design
- Time perspective
- Prospective
- Target follow-up
- 20 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral Lower Limb Loss | – | Other: No interventionIndividuals with unilateral lower limb loss will be participants of the group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with traumatic lower limb loss
Key inclusion criteria (1 listed)
- Individuals with unilateral lower limb loss Traumatic limb loss Age between 20-55 years Using conventional type socket design Dynamic foot using
Key exclusion criteria (1 listed)
- Have passive joint limitation at extremities Surgery at last 1 year Systemic problems such as neurologic disorders, rheumatoid disorders… Another orthopedic anomalies
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 |
|---|---|---|
| No intervention | Other | Unilateral Lower Limb Loss |
Primary outcome
Step length variability assesment while walking.
Time frame: Initially evaluation at first minute
Gait parameters (step length, variation of step length) will be evaluated with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 2nd and 4th minutes at walk.
2 secondary outcomes
Phantom sensation and phantom pain assessment
Time frame: Initially evaluation at first minute
Sensory test
Time frame: Initially evaluation at first minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic, run by Hacettepe University.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. 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?
Results are not available in the source record.
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?
Step length variability assesment while walking. (time frame: Initially evaluation at first minute). 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 14 Oct 2016.