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

NCT05831748 | Completed

• 1 other identifier: E-10840098-772.02-2675
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prosthesis User

Keywords

pilates; gait analyses; balance; prosthesis; amputation

Outcome Measures

Primary Outcomes (1)

• Gait analyses

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

  10 Minutes

Secondary Outcomes (5)

• The tandem walk test (TWT)

  1 minute

• Berg Balance Scale

  20 minutes

• Six Minute Walk Test

  6 minutes

• Core muscle endurance test

  1-3 minutes

• SF-36 (Short Form 36)

  5-10 minutes

Study Arms (2)

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.

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.

Other: Clinical Pilates

Interventions

Classic Exercise OTHER

Classic exercise group consists of straight leg raising, back extensor strengthening, and abdominal strengthening exercises.

Experimental Group

Clinical Pilates OTHER

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.

Active Comparator group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30889496 RESULT

• 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.

  PMID: 15125916 RESULT

• 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.

  PMID: 29351504 RESULT

• 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.

  PMID: 18569891 RESULT

• 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.

  PMID: 24287245 RESULT

Study Officials

• Albina Alikaj, PhD(c)

  Medipol University

  PRINCIPAL INVESTIGATOR

• Esra Atılgan, Assoc.Prof.

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 26, 2023
• Study Start: January 24, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

TU (1)