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

Medipol University

Status: Completed

Conditions: Prosthesis User

Treatments: Other: Clinical Pilates; Other: Classic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05831748

E-10840098-772.02-2675

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Classic Exercise

Active Comparator group

Active Comparator group

Description:

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.

Treatment:

Other: Clinical Pilates