Transfemoral AmputeesNCT04644991
The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
A study testing Kinesiology taping and Six minutes walking test in people with Transfemoral Amputees and Kinesiology Taping, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
With the initiation of prosthesis use following lower extremity amputations, the body shows biomechanical changes according to the amputation level, and as a result, it develops adaptation mechanisms on both the healthy and ampute sides. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Transfemoral Amputees, Kinesiology Taping
- What is being tested?
- Kinesiology taping and Six minutes walking test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 23 Apr 2021
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-60
- Having unilateral transfemoral amputation
- Using prosthesis for at least 6 months
- Good prosthesis comfort
Who cannot join
- Body mass index>30
- Having a history of surgery in the lumbar region in past 6 months
- Participating in a physiotherapy and rehabilitation program for a low back pain past six months
- Neurological and / or orthopedic disorders other than amputation
- Having low back pain for at least 3 months before amputation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of the Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
With the initiation of prosthesis use following lower extremity amputations, the body shows biomechanical changes according to the amputation level, and as a result, it develops adaptation mechanisms on both the healthy and ampute sides. It has been reported that the most common secondary pathology caused by these mechanisms developed to compensate the amputated side is lower back pain and adaptation mechanisms vary according to the presence of pain. Adaptation strategies in transfemoral amputees cause permanent changes in the connective tissue structure properties of the toracolumbar region and reduce the contribution of these structures to dynamic stability. It has been reported that with the fascia correction technique, one of the kinesiological taping techniques, the connective tissue fiber alignment can be rearranged and the degree of stiffness can be reduced. Before the intervention, biomechanical properties of the toracolumbar region structures with MyotonPro and postural stability measurements with TekScan will be taken.
- Conditions
- Transfemoral Amputees, Kinesiology Taping
- Being tested
- Kinesiology taping, Six minutes walking test, Shame Kinesiology Tape
- Keywords
- amputation, transfemoral, thoracolumbal fascia, kinesiotape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology tapingOther
Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.
Six minutes walking testOther
Participants will be asked to walk as fast as they can for 6 minutes.
Shame Kinesiology TapeOther
Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | Experimental group consisting of transfemoral amputees who kinesiology tape will be applied Receives: Other: Kinesiology taping; Other: Six minutes walking test |
| ShamKinesiotape | Sham comparator | The placebo group of transfemoral amputees who shame kinesiology tape will be applied Receives: Other: Six minutes walking test; Other: Shame Kinesiology Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Postural Stability
The center of gravity displacement (cm2) will be measured at standing position on force platform during 30sn
Measured: Changes from baseline of center of gravity displacement at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
Measurement of Stiffness
Stiffness of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
Measured: Changes from baseline of stifness of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
Measurement of Creep
Creep value of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
Measured: Changes from baseline of creep of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying
Secondary outcomes (1)
Low back pain
Low back pain will be measured by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain)
Measured: Changes from baseline of low back pain at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Mar 2021
- Primary completion30 Mar 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Transfemoral AmputeesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644991
- Sponsor's protocol ID
- 20/100
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
PubMed 18566923Morgenroth DC, Orendurff MS, Shakir A, Segal A, Shofer J, Czerniecki JM. The relationship between lumbar spine kinematics during gait and low-back pain in transfemoral amputees. Am J Phys Med Rehabil. 2010 Aug;89(8):635-43. doi: 10.1097/PHM.0b013e3181e71d90.
PubMed 20647781Murray AM, Gaffney BM, Davidson BS, Christiansen CL. Biomechanical compensations of the trunk and lower extremities during stepping tasks after unilateral transtibial amputation. Clin Biomech (Bristol). 2017 Nov;49:64-71. doi: 10.1016/j.clinbiomech.2017.08.010. Epub 2017 Aug 30.
PubMed 28888109Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
PubMed 22630613Yahia L, Rhalmi S, Newman N, Isler M. Sensory innervation of human thoracolumbar fascia. An immunohistochemical study. Acta Orthop Scand. 1992 Apr;63(2):195-7. doi: 10.3109/17453679209154822.
PubMed 1590057Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
PubMed 21589701Kalichman L, Vered E, Volchek L. Relieving symptoms of meralgia paresthetica using Kinesio taping: a pilot study. Arch Phys Med Rehabil. 2010 Jul;91(7):1137-9. doi: 10.1016/j.apmr.2010.03.013.
PubMed 20537313
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT04644991
- Acronym / sponsor ID
- 20/100
- Conditions
- Transfemoral Amputees, Kinesiology Taping
- Keywords
- amputation, transfemoral, thoracolumbal fascia, kinesiotape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 25 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.
With the initiation of prosthesis use following lower extremity amputations, the body shows biomechanical changes according to the amputation level, and as a result, it develops adaptation mechanisms on both the healthy and ampute sides. It has been reported that the most common secondary pathology caused by these mechanisms developed to compensate the amputated side is lower back pain and adaptation mechanisms vary according to the presence of pain. Adaptation strategies in transfemoral amputees cause permanent changes in the connective tissue structure properties of the toracolumbar region and reduce the contribution of these structures to dynamic stability. It has been reported that with the fascia correction technique, one of the kinesiological taping techniques, the connective tissue fiber alignment can be rearranged and the degree of stiffness can be reduced. Before the intervention, biomechanical properties of the toracolumbar region structures with MyotonPro and postural stability measurements with TekScan will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Other: Kinesiology taping, Other: Six minutes walking testExperimental group consisting of transfemoral amputees who kinesiology tape will be applied |
| ShamKinesiotape | Sham comparator | Other: Six minutes walking test, Other: Shame Kinesiology TapeThe placebo group of transfemoral amputees who shame kinesiology tape will be applied |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-60
- Having unilateral transfemoral amputation
- Using prosthesis for at least 6 months
- Good prosthesis comfort
Key exclusion criteria (5 listed)
- Body mass index>30
- Having a history of surgery in the lumbar region in past 6 months
- Participating in a physiotherapy and rehabilitation program for a low back pain past six months
- Neurological and / or orthopedic disorders other than amputation
- Having low back pain for at least 3 months before amputation
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 |
|---|---|---|
| Kinesiology tapingY-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup. | Other | Kinesiotape |
| Six minutes walking testParticipants will be asked to walk as fast as they can for 6 minutes. | Other | Kinesiotape, ShamKinesiotape |
| Shame Kinesiology TapeSham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup. | Other | ShamKinesiotape |
Primary outcome
Measurement of Postural Stability
Time frame: Changes from baseline of center of gravity displacement at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
The center of gravity displacement (cm2) will be measured at standing position on force platform during 30sn
Measurement of Stiffness
Time frame: Changes from baseline of stifness of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
Stiffness of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
Measurement of Creep
Time frame: Changes from baseline of creep of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying
Creep value of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
1 secondary outcome
Low back pain
Time frame: Changes from baseline of low back pain at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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 3 Feb 2022.
- Results publication: PubMed 18566923Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
- Results publication: PubMed 20647781Morgenroth DC, Orendurff MS, Shakir A, Segal A, Shofer J, Czerniecki JM. The relationship between lumbar spine kinematics during gait and low-back pain in transfemoral amputees. Am J Phys Med Rehabil. 2010 Aug;89(8):635-43. doi: 10.1097/PHM.0b013e3181e71d90.
- Results publication: PubMed 28888109Murray AM, Gaffney BM, Davidson BS, Christiansen CL. Biomechanical compensations of the trunk and lower extremities during stepping tasks after unilateral transtibial amputation. Clin Biomech (Bristol). 2017 Nov;49:64-71. doi: 10.1016/j.clinbiomech.2017.08.010. Epub 2017 Aug 30.
- Results publication: PubMed 22630613Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
- Results publication: PubMed 1590057Yahia L, Rhalmi S, Newman N, Isler M. Sensory innervation of human thoracolumbar fascia. An immunohistochemical study. Acta Orthop Scand. 1992 Apr;63(2):195-7. doi: 10.3109/17453679209154822.
- Results publication: PubMed 21589701Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
- Results publication: PubMed 20537313Kalichman L, Vered E, Volchek L. Relieving symptoms of meralgia paresthetica using Kinesio taping: a pilot study. Arch Phys Med Rehabil. 2010 Jul;91(7):1137-9. doi: 10.1016/j.apmr.2010.03.013.
- 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.
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?
A study testing Kinesiology taping and Six minutes walking test in people with Transfemoral Amputees and Kinesiology Taping, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 5 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 3 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Measurement of Postural Stability (time frame: Changes from baseline of center of gravity displacement at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.). 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?
On the ClinicalTrials.gov record for NCT04644991, which also lists 7 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 3 Feb 2022.