Prosthesis UserNCT05831748
The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users
A study testing Classic Exercise and Clinical Pilates in people with Prosthesis User, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Studies have shown that Pilates exercises are one of the exercises that can improve breathing capacity, coordination, balance, flexibility, and muscular endurance. Pilates exercises improve walking and balance, reduce back pain and prevent further pain or injury. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User
- What is being tested?
- Classic Exercise and Clinical Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2023to 15 Aug 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a Volunteer,
- Being at least 6 months after amputation,
- Having no problems related to prostheses,
- Using a hydraulic, pneumatic, or microprocessor knee joint type,
- According to the functional classification of amputees, individuals at the K3-K4 level,
- Individuals with unilateral transtibial, unilateral transfemoral amputation
Who cannot join
- Users using assistive devices,
- Those with bilateral amputation,
- Those having contractures,
- Those with acute low back pain,
- Spine and lower extremity involvement due to systemic inflammation (rheumatoid arthritis, spondyloarthropathy, etc.),
- Systemic neurological disease (Multiple sclerosis, Alzheimer's, etc.),
- Patients with other diseases that prevent mobilization (vertigo, cerebellar ataxia, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Studies have shown that Pilates exercises are one of the exercises that can improve breathing capacity, coordination, balance, flexibility, and muscular endurance. Pilates exercises improve walking and balance, reduce back pain and prevent further pain or injury. These are all common problems for people who have undergone lower extremity amputation. The aim of our study is to improve the pelvis-trunk coordination, gait symmetry, and balance on individuals who have undergone amputation and also to increase body awareness.
Read the detailed description
The patients will be randomly assigned to two groups. Clinical Pilates (CP) and Classic Physiotherapy (CF). Two groups will be Transfemoral and Transtibial amputees, one CP, and the other CF. Groups will be treated for a period of 12 weeks. The assessment will be made before the treatment and after 12 weeks. Patients will practise exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise.
In the clinical Pilates group, exercises that improve back extensor, trunk flexor, and pelvis stabilization will be applied along with breathing exercises. The classic group consists of straight leg raising, back extensors strengthening, abdominal strengthening exercises.
Gait spatiotemporal parameters, balance, fall risk and mobility, functional capacity, core muscle endurance, and strength, the pain will be evaluated. Quality of life, body image, and also prosthesis satisfaction will be evaluated.
- Conditions
- Prosthesis User
- Being tested
- Classic Exercise, Clinical Pilates
- Keywords
- pilates, gait analyses, balance, prosthesis, amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic ExerciseOther
Classic exercise group consists of straight leg raising, back extensor strengthening, and abdominal strengthening exercises.
Clinical PilatesOther
In the Clinical pilates group, pilates exercises will be given. Clinical pilates exercises improve back extensors, trunk flexors, and pelvis stabilization. These exercises will be applied along with breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 15 Transfemoral and Transtibial amputees will be included in this group. Patients will be treated with classic physiotherapy exercises for 12 weeks. Patients will practice exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise. Receives: Other: Classic Exercise |
| Active Comparator group | Active comparator | 15 Transfemoral and Transtibial amputees will be included in this group. Patients will be treated with Clinical pilates exercises for 12 weeks. Patients will practice exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise. Receives: Other: Clinical Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analyses
Basic gait parameters include walking speed, step length and cadence will be evaluated.
Measured: 10 Minutes
Secondary outcomes (5)
The tandem walk test (TWT)
The tandem walk test (TWT) is a physical performance test used to assess balance and coordination. During the TWT, the individual is asked to walk a straight line, placing the heel of one foot directly in front of the toes of the other foot. This creates a "tandem" or heel-to-toe gait. The individual is instructed to take as many steps as possible along the line without stepping off or losing balance. The TWT is typically performed over a distance of 3-5 meters, and the time it takes the individual to complete the test is recorded.
Measured: 1 minute
Berg Balance Scale
The Berg Balance Scale (BBS) is a widely used clinical assessment tool that is used to measure an individual's ability to maintain balance during different functional tasks. The BBS consists of 14 different tasks that assess different aspects of balance, including sitting unsupported, standing unsupported, transferring from sitting to standing, standing with eyes closed, standing with feet together, turning 360 degrees, reaching forward, retrieving objects from the floor, and stepping up and down on a stool.
Each task is scored on a 5-point scale, with a maximum score of 56 points. The scores for each task are summed to obtain a total score, which provides a measure of the individual's overall balance performance. Higher scores indicate better balance performance, while lower scores indicate greater difficulty maintaining balance.
Measured: 20 minutes
Six Minute Walk Test
The 6-minute walk test (6MWT) is a simple and widely used clinical tool to assess the exercise capacity and functional status of a person. It involves measuring the distance a person can walk on a flat surface in 6 minutes at their own comfortable pace.
The general steps involved in performing a 6MWT:
The person is given instructions on how to perform the test, which includes walking as far as they can within 6 minutes without running.
The person is allowed to rest for a short period of time (usually 10-15 minutes) before the test begins.
The person is asked to walk back and forth along a marked 30-meter course or a long hallway.
The person's oxygen saturation level, heart rate, and blood pressure are monitored before and after the test.
The total distance covered by the person in 6 minutes is measured. The test will be performed in a controlled environment, such as a clinic, and is supervised by a specialised physiotherapist.
Measured: 6 minutes
Core muscle endurance test
The core muscle endurance test is a measure of the endurance of the muscles of core, which includes your abdominal muscles, back muscles, and pelvic muscles. The test is typically used to evaluate core strength and muscular endurance. To perform the core muscle endurance test, a timer and a mat is needed. These steps should be followed:
Lie down on your back on the mat with your arms at your sides and your knees bent.
Lift your feet off the ground so that your knees are at a 90-degree angle. Raise your head and shoulders off the mat, keeping your chin tucked and your neck relaxed.
Hold this position for as long as you can, keeping your knees at a 90-degree angle and your feet off the ground.
Stop the timer when you can no longer maintain the position or when your form begins to suffer.
The test measures the time you can hold this position, with longer times indicating greater core muscle endurance. A good score for the test varies depending on age, sex, and fitness level.
Measured: 1-3 minutes
SF-36 (Short Form 36)
SF-36 (Short Form 36) is a questionnaire used to measure health-related quality of life. Shorter version of the SF-12 questionnaire and contains 36 questions that assess eight health concepts, including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start24 Jan 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albina Alikaj, Medipol University
- Investigators
- Albina Alikaj, PhD(c), Principal investigator, Medipol UniversityEsra Atılgan, Assoc.Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831748
- Sponsor's protocol ID
- E-10840098-772.02-2675
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Varrecchia T, Serrao M, Rinaldi M, Ranavolo A, Conforto S, De Marchis C, Simonetti A, Poni I, Castellano S, Silvetti A, Tatarelli A, Fiori L, Conte C, Draicchio F. Common and specific gait patterns in people with varying anatomical levels of lower limb amputation and different prosthetic components. Hum Mov Sci. 2019 Aug;66:9-21. doi: 10.1016/j.humov.2019.03.008. Epub 2019 Mar 16.
PubMed 30889496den Otter AR, Geurts AC, Mulder T, Duysens J. Speed related changes in muscle activity from normal to very slow walking speeds. Gait Posture. 2004 Jun;19(3):270-8. doi: 10.1016/S0966-6362(03)00071-7.
PubMed 15125916Ulger O, Yildirim Sahan T, Celik SE. A systematic literature review of physiotherapy and rehabilitation approaches to lower-limb amputation. Physiother Theory Pract. 2018 Nov;34(11):821-834. doi: 10.1080/09593985.2018.1425938. Epub 2018 Jan 19.
PubMed 29351504Asano M, Rushton P, Miller WC, Deathe BA. Predictors of quality of life among individuals who have a lower limb amputation. Prosthet Orthot Int. 2008 Jun;32(2):231-43. doi: 10.1080/03093640802024955.
PubMed 18569891Esquenazi A. Gait analysis in lower-limb amputation and prosthetic rehabilitation. Phys Med Rehabil Clin N Am. 2014 Feb;25(1):153-67. doi: 10.1016/j.pmr.2013.09.006.
PubMed 24287245
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users
- ClinicalTrials.gov ID
- NCT05831748
- Acronym / sponsor ID
- E-10840098-772.02-2675
- Conditions
- Prosthesis User
- Keywords
- pilates, gait analyses, balance, prosthesis, amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 26 Apr 2023 (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.
Studies have shown that Pilates exercises are one of the exercises that can improve breathing capacity, coordination, balance, flexibility, and muscular endurance. Pilates exercises improve walking and balance, reduce back pain and prevent further pain or injury. These are all common problems for people who have undergone lower extremity amputation. The aim of our study is to improve the pelvis-trunk coordination, gait symmetry, and balance on individuals who have undergone amputation and also to increase body awareness.
Detailed description
The patients will be randomly assigned to two groups. Clinical Pilates (CP) and Classic Physiotherapy (CF). Two groups will be Transfemoral and Transtibial amputees, one CP, and the other CF. Groups will be treated for a period of 12 weeks. The assessment will be made before the treatment and after 12 weeks. Patients will practise exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise.
In the clinical Pilates group, exercises that improve back extensor, trunk flexor, and pelvis stabilization will be applied along with breathing exercises. The classic group consists of straight leg raising, back extensors strengthening, abdominal strengthening exercises.
Gait spatiotemporal parameters, balance, fall risk and mobility, functional capacity, core muscle endurance, and strength, the pain will be evaluated. Quality of life, body image, and also prosthesis satisfaction will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Classic Exercise15 Transfemoral and Transtibial amputees will be included in this group. Patients will be treated with classic physiotherapy exercises for 12 weeks. Patients will practice exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise. |
| Active Comparator group | Active comparator | Other: Clinical Pilates15 Transfemoral and Transtibial amputees will be included in this group. Patients will be treated with Clinical pilates exercises for 12 weeks. Patients will practice exercises 3 times a week, one time in clinics with a physiotherapist and 2 times as home exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be a Volunteer,
- Being at least 6 months after amputation,
- Having no problems related to prostheses,
- Using a hydraulic, pneumatic, or microprocessor knee joint type,
- According to the functional classification of amputees, individuals at the K3-K4 level,
Key exclusion criteria (7 listed)
- Users using assistive devices,
- Those with bilateral amputation,
- Those having contractures,
- Those with acute low back pain,
- Spine and lower extremity involvement due to systemic inflammation (rheumatoid arthritis, spondyloarthropathy, etc.),
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 |
|---|---|---|
| Classic ExerciseClassic exercise group consists of straight leg raising, back extensor strengthening, and abdominal strengthening exercises. | Other | Experimental Group |
| Clinical PilatesIn the Clinical pilates group, pilates exercises will be given. Clinical pilates exercises improve back extensors, trunk flexors, and pelvis stabilization. These exercises will be applied along with breathing exercises. | Other | Active Comparator group |
Primary outcome
Gait analyses
Time frame: 10 Minutes
Basic gait parameters include walking speed, step length and cadence will be evaluated.
5 secondary outcomes
The tandem walk test (TWT)
Time frame: 1 minute
Berg Balance Scale
Time frame: 20 minutes
Six Minute Walk Test
Time frame: 6 minutes
Core muscle endurance test
Time frame: 1-3 minutes
SF-36 (Short Form 36)
Time frame: 5-10 minutes
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 20 Nov 2025.
- Results publication: PubMed 30889496Varrecchia T, Serrao M, Rinaldi M, Ranavolo A, Conforto S, De Marchis C, Simonetti A, Poni I, Castellano S, Silvetti A, Tatarelli A, Fiori L, Conte C, Draicchio F. Common and specific gait patterns in people with varying anatomical levels of lower limb amputation and different prosthetic components. Hum Mov Sci. 2019 Aug;66:9-21. doi: 10.1016/j.humov.2019.03.008. Epub 2019 Mar 16.
- Results publication: PubMed 15125916den Otter AR, Geurts AC, Mulder T, Duysens J. Speed related changes in muscle activity from normal to very slow walking speeds. Gait Posture. 2004 Jun;19(3):270-8. doi: 10.1016/S0966-6362(03)00071-7.
- Results publication: PubMed 29351504Ulger O, Yildirim Sahan T, Celik SE. A systematic literature review of physiotherapy and rehabilitation approaches to lower-limb amputation. Physiother Theory Pract. 2018 Nov;34(11):821-834. doi: 10.1080/09593985.2018.1425938. Epub 2018 Jan 19.
- Results publication: PubMed 18569891Asano M, Rushton P, Miller WC, Deathe BA. Predictors of quality of life among individuals who have a lower limb amputation. Prosthet Orthot Int. 2008 Jun;32(2):231-43. doi: 10.1080/03093640802024955.
- Results publication: PubMed 24287245Esquenazi A. Gait analysis in lower-limb amputation and prosthetic rehabilitation. Phys Med Rehabil Clin N Am. 2014 Feb;25(1):153-67. doi: 10.1016/j.pmr.2013.09.006.
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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.
Albina Alikaj, PhD(c) principal investigator
Medipol University
Esra Atılgan, Assoc.Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Exercise and Clinical Pilates in people with Prosthesis User, run by Medipol 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 6 inclusion and 7 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 20 Nov 2025. 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?
Gait analyses (time frame: 10 Minutes). 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 NCT05831748, which also lists 5 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 20 Nov 2025.