AmputationNCT02988310
Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss
An observational study of Amputation, run by Hacettepe University.
Trial summary
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals 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 will be recorded. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals with unilateral below or above knee limb loss
Who may be able to join
- Individuals with unilateral above knee lower limb loss and below knee 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 neurological disorders, rheumatoid disorders
- Another orthopedic anomalies
About this study
Official title: Comparison of Gait Characteristics in Individuals With Trans Femaoral and Trans Tibial Limb Loss
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals 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 will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.
Read the detailed description
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this study.
Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index, gait speed) 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 4nd and 6th minutes at walk.
- Conditions
- Amputation
- Being tested
- No intervention
- Keywords
- Limb Loss, Gait Characteristics
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 |
|---|---|---|
| Individuals with below knee limb loss | Individuals with below knee limb loss will be participants of the group. Receives: Other: No intervention | |
| Individuals with above knee limb loss | Individuals with above knee limb loss will be participants of the group. Receives: Other: No intervention | |
| Healthy individuals | Healthy individuals 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 assesment while walking.
Measured: Initially evaluation at first minute
Secondary outcomes (1)
Ambulation index assessment while walking.
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 posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 39 participants (estimated)
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
- NCT02988310
- Sponsor's protocol ID
- G10
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gait Characteristics in Individuals With Trans Femaoral and Trans Tibial Limb Loss
- ClinicalTrials.gov ID
- NCT02988310
- Acronym / sponsor ID
- G10
- Conditions
- Amputation
- Keywords
- Limb Loss, Gait Characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 9 Dec 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.
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals 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 will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.
Detailed description
Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this study.
Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index, gait speed) 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 4nd and 6th minutes at walk.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with below knee limb loss | – | Other: No interventionIndividuals with below knee limb loss will be participants of the group. |
| Individuals with above knee limb loss | – | Other: No interventionIndividuals with above knee limb loss will be participants of the group. |
| Healthy individuals | – | Other: No interventionHealthy individuals will be participants of the group. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals with unilateral below or above knee limb loss
Key inclusion criteria (3 listed)
- Individuals with unilateral above knee lower limb loss and below knee limb loss
- Age between 20-55 years
- Using conventional type socket design Dynamic foot using
Key exclusion criteria (4 listed)
- Have passive joint limitation at extremities
- Surgery at last 1 year
- Systemic problems such as neurological 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 | Healthy individuals, Individuals with above knee limb loss, Individuals with below knee limb loss |
Primary outcome
Step length assesment while walking.
Time frame: Initially evaluation at first minute
1 secondary outcome
Ambulation index assessment while walking.
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 9 Dec 2016.
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
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, 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 3 inclusion and 4 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 9 Dec 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 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 9 Dec 2016.