The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users

Prosthesis User Clinical Trial

Official title:

The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831748
• Other study ID #: E-10840098-772.02-2675
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: Medipol University
• Contact: Albina Alikaj, PhD(c)
• Phone: 444 85 44
• Email: alikajalbina[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.).

Related Conditions & MeSH terms

• Prosthesis User

Intervention

Other:
• Classic Exercise
Classic exercise group consists of straight leg raising, back extensor strengthening, and abdominal strengthening exercises.
• Clinical Pilates
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 am — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait analyses	Basic gait parameters include walking speed, step length and cadence will be evaluated.	10 Minutes
Secondary	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.	1 minute
Secondary	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.	20 minutes
Secondary	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.	6 minutes
Secondary	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.	1-3 minutes
Secondary	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.	5-10 minutes