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AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, 34810

Other trials in Turkey (Türkiye)

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 groups in NCT05831748
Study groupRoleWhat they receive
Experimental GroupExperimental15 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 groupActive comparator15 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.

  1. Gait analyses

    Basic gait parameters include walking speed, step length and cadence will be evaluated.

    Measured: 10 Minutes

Secondary outcomes (5)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted26 Apr 2023
  2. Study start24 Jan 2023
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

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)
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 30889496
  • den 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 15125916
  • Ulger 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 29351504
  • Asano 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 18569891
  • Esquenazi 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

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.

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