Clinical trial NCT05831748: The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users
Official title: The Effects of Clinical Pilates Training on Balance and Walking in Lower Limb Prosthesis Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis User
Keywords: pilates
gait analyses
balance
prosthesis
amputation
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Gait analyses
timeFrame: 10 Minutes
Secondary outcomes:
measure: The tandem walk test (TWT)
timeFrame: 1 minute
measure: Berg Balance Scale
timeFrame: 20 minutes
measure: Six Minute Walk Test
timeFrame: 6 minutes
measure: Core muscle endurance test
timeFrame: 1-3 minutes
measure: SF-36 (Short Form 36)
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Albina Alikaj, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Esra Atılgan, Assoc.Prof.
role: STUDY_DIRECTOR
References:
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 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.
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.
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.
citation: 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.
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.