Stair up and Down, AmputationNCT04324788
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.
An observational study of Stair up and Down, Amputation and Amputation,Stair up and Down, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Stair up and Down, Amputation, Amputation,Stair up and Down
- What is being tested?
- Group 1 and Group 2
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 20 Dec 2020
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Study population: Unilateral transfemoral and transtibial amputate patients
Who may be able to join
- to be TTA and TFA
- No complaints of chronic low back pain before amputation
- Using prosthesis for at least 6 months
- Being able to climb up and down stairs
- No history of falls that will cause injury or pain in the past 6 months
- Having good prosthesis comfort
- BMI<28.5
- Who can have cognitive functions to understand Arabic language
Who cannot join
- To be amputated due to congenital and tumor
- Who can not have cognitive functions to understand Arabic language
- Having orthopedic or neurological disorders that may cause chronic pain or functional impairment in the lumbar region
- Ankylosing spondolitis and rheumatoid arthritis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Transtibial and Transfemoral Amputes.
With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological structure of the muscle, especially in the muscles of the waist, hip and knee and recruitment.
The aim of this study is to investigate the effect of stairing up and down activity on the mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with lower lumbar region pain.
- Being tested
- Group 1, Group 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
Group 2Other
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Transtibial amputation
The patients will be asked to go up and down 9-step stair with the highest speed they can make. Receives: Other: Group 1 | |
| Group 2 | Transfemoral amputation
The patients will be asked to go up and down 9-step stair with the highest speed they can make. Receives: Other: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the mechanical properties of the muscle-1
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Measured: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the mechanical properties of the muscle-2
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Measured: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the mechanical properties of the muscle-3
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Measured: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the back pain
Pain will be evaluated by using Visual analog scale ranging 0 (no pain)- 10 (worst pain)
Measured: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the pressure-pain threshold
The pressure-pain threshold (lbs) will be measured in algometer commander (JTECH MEDICAL, MM036_K, 2016)
Measured: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Feb 2020
- Primary completion15 Apr 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stair up and Down, AmputationStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324788
- Sponsor's protocol ID
- 09.2019.969
- Status last verified
- Sep 2021
- First submitted
- 24 Mar 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devan H, Hendrick P, Ribeiro DC, Hale LA, Carman A. Asymmetrical movements of the lumbopelvic region: is this a potential mechanism for low back pain in people with lower limb amputation? Med Hypotheses. 2014 Jan;82(1):77-85. doi: 10.1016/j.mehy.2013.11.012. Epub 2013 Nov 16.
PubMed 24296234Hendershot BD, Bazrgari B, Nussbaum MA. Persons with unilateral lower-limb amputation have altered and asymmetric trunk mechanical and neuromuscular behaviors estimated using multidirectional trunk perturbations. J Biomech. 2013 Jul 26;46(11):1907-12. doi: 10.1016/j.jbiomech.2013.04.018. Epub 2013 May 29.
PubMed 23726183Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
PubMed 28066528Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
PubMed 30254233Michaud SB, Gard SA, Childress DS. A preliminary investigation of pelvic obliquity patterns during gait in persons with transtibial and transfemoral amputation. J Rehabil Res Dev. 2000 Jan-Feb;37(1):1-10.
PubMed 10847567Kelly-Martin R, Doughty L, Garkavi M, Wasserman JB. Reliability of modified adheremeter and digital pressure algometer in measuring normal abdominal tissue and C-section scars. J Bodyw Mov Ther. 2018 Oct;22(4):972-979. doi: 10.1016/j.jbmt.2018.02.017. Epub 2018 Feb 17.
PubMed 30368344
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Transtibial and Transfemoral Amputes.
- ClinicalTrials.gov ID
- NCT04324788
- Acronym / sponsor ID
- 09.2019.969
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 27 Mar 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.
With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological structure of the muscle, especially in the muscles of the waist, hip and knee and recruitment.
The aim of this study is to investigate the effect of stairing up and down activity on the mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with lower lumbar region pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Group 1Transtibial amputation The patients will be asked to go up and down 9-step stair with the highest speed they can make. |
| Group 2 | – | Other: Group 2Transfemoral amputation The patients will be asked to go up and down 9-step stair with the highest speed they can make. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unilateral transfemoral and transtibial amputate patients
Key inclusion criteria (8 listed)
- to be TTA and TFA
- No complaints of chronic low back pain before amputation
- Using prosthesis for at least 6 months
- Being able to climb up and down stairs
- No history of falls that will cause injury or pain in the past 6 months
Key exclusion criteria (4 listed)
- To be amputated due to congenital and tumor
- Who can not have cognitive functions to understand Arabic language
- Having orthopedic or neurological disorders that may cause chronic pain or functional impairment in the lumbar region
- Ankylosing spondolitis and rheumatoid arthritis patients
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 |
|---|---|---|
| Group 1The patients will be asked to go up and down 9-step stair with the highest speed they can make. | Other | Group 1 |
| Group 2The patients will be asked to go up and down 9-step stair with the highest speed they can make. | Other | Group 2 |
Primary outcome
Evaluation of the mechanical properties of the muscle-1
Time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Evaluation of the mechanical properties of the muscle-2
Time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Evaluation of the mechanical properties of the muscle-3
Time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Evaluation of the back pain
Time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Pain will be evaluated by using Visual analog scale ranging 0 (no pain)- 10 (worst pain)
Evaluation of the pressure-pain threshold
Time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
The pressure-pain threshold (lbs) will be measured in algometer commander (JTECH MEDICAL, MM036_K, 2016)
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 4 Oct 2021.
- Background: PubMed 24296234Devan H, Hendrick P, Ribeiro DC, Hale LA, Carman A. Asymmetrical movements of the lumbopelvic region: is this a potential mechanism for low back pain in people with lower limb amputation? Med Hypotheses. 2014 Jan;82(1):77-85. doi: 10.1016/j.mehy.2013.11.012. Epub 2013 Nov 16.
- Background: PubMed 23726183Hendershot BD, Bazrgari B, Nussbaum MA. Persons with unilateral lower-limb amputation have altered and asymmetric trunk mechanical and neuromuscular behaviors estimated using multidirectional trunk perturbations. J Biomech. 2013 Jul 26;46(11):1907-12. doi: 10.1016/j.jbiomech.2013.04.018. Epub 2013 May 29.
- Background: PubMed 28066528Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
- Background: PubMed 30254233Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
- Background: PubMed 10847567Michaud SB, Gard SA, Childress DS. A preliminary investigation of pelvic obliquity patterns during gait in persons with transtibial and transfemoral amputation. J Rehabil Res Dev. 2000 Jan-Feb;37(1):1-10.
- Background: PubMed 30368344Kelly-Martin R, Doughty L, Garkavi M, Wasserman JB. Reliability of modified adheremeter and digital pressure algometer in measuring normal abdominal tissue and C-section scars. J Bodyw Mov Ther. 2018 Oct;22(4):972-979. doi: 10.1016/j.jbmt.2018.02.017. Epub 2018 Feb 17.
- Individual participant dataSharing planned: No
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.
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 Stair up and Down, Amputation and Amputation,Stair up and Down, run by Marmara University 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 8 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: finished, as of the sponsor's last update on 4 Oct 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?
Evaluation of the mechanical properties of the muscle-1 (time frame: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324788, which also lists 6 linked publications.
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 4 Oct 2021.