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

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.

Study Overview

• Status: Recruiting
• Conditions: Prosthesis User
• Intervention / Treatment: Other: Classic Exercise; Other: Clinical Pilates

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Albina Alikaj, PhD(c); Phone Number: 444 85 44; Email: alikajalbina@gmail.com
• Study Contact Backup: Name: Alika

Study Locations

• Turkey
  • Istanbul, Turkey, 34810
    • Recruiting
    • Istanbul Medipol University
    • Contact: Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Other: Classic Exercise; Classic exercise group consists of straight leg raising, back extensor strengthening, and abdominal strengthening exercises.
Active Comparator: Active Comparator group; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analyses	Basic gait parameters include walking speed, step length and cadence will be evaluated.	10 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Albina Alikaj, PhD(c), Medipol University; Study Director: Esra Atılgan, Assoc.Prof., Medipol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: prosthesis; balance; amputation; pilates; gait analyses
• Other Study ID Numbers: E-10840098-772.02-2675

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No