Skip to main content
OpenTrials
Completed

NCT Number: NCT04360447

Comparison of Pilates &Home Exercise Programs on Muscle Strength in Paraplegic Patients

Paraplegic patients to be included in the study were divided into 2 groups by randomization and it was planned to apply reformer pilates or home exercise programs for 8 weeks. It was aimed to compare upper extremity muscle strengths, Spinal Cord Independence Measure version III (SCIM-III) and the Short Form(36) Health Survey (SF-36) data before and after treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

Spinal cord injuries (SCI) are injuries that occur as a result of compression, incision or contusion of the spinal cord, which extends from foramen magnum to cauda equina.These patients experience various complications and organ system damage in the chronic period.Their self-dependence is affected by the level of injury. One of the most important factors affecting the self-dependence of people with SCI is the strength of the upper extremity.Strong upper extremities are needed for independent transfer from bed.

SCI patients member of Turkish Spinal Cord Injury Association, according to the criteria for inclusion in the study patient list was created. In accordance with the sample size with the random numbers prepared with a computer program from this list, 18 people were planned to be included in the study. The patients were planned to be randomly divided into the study and control groups.Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks; A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.It was planned to record the demographic data of the patients (age, gender, occupation, additional disease).It was planned to fill the SF-36 form to measure the quality of life of the patients, SCIM-III forms to evaluate functionally and measure the upper extremity muscle strength with a hand dynamometer.

At the end of 8 weeks, the patients were called for an examination, and SF-36, SCIM-III forms were filled and muscle strength was measured, and the comparison was aimed within the group and between the groups.In our study, our aim is to demonstrate the applicability of the reformer pilates program in SCI patients. In addition, to show the effects of home exercise program and reformer pilates programs on upper extremity muscle strength in SCI patients with multiple comparison tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteering for study
  • Lesion level: T2 and below diagnosed with SCI
  • Lesion duration over 2 years
  • Ambulation in wheelchair
  • To ensure randomization, SCI patients must be a member of Turkish Spinal Cord Injury Association and which should not be included in any study group.

Exclusion criteria

  • Severe psychiatric disorder
  • General condition disorder (heart failure, lung failure)
  • Intolerably shoulder pain during exercise

Treatment and study plan

Reformer Pilates

Device

Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.

Home exercise

Other

A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.

Primary outcomes

  1. the upper extremity muscle strength

    Time frame: 8 weeks

    measure the upper extremity muscle strength with a hand dynamometer

Secondary outcomes

  1. the Short Form(36) Health Survey (SF-36)

    Time frame: 8 weeks

    The SF-36 is a measure of health status.It consists of eight scaled scores, which are the weighted sums of the questions in their section. The lower the score the more disability.

  2. Spinal Cord Independence Measure version III (SCIM-III)

    Time frame: 8 weeks

    SCIM-III is a measurement tool for determining the level of function in spinal cord injury

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of Reformer Pilates and Home Exercise Programs on Upper Extremity Muscle Strength in Paraplegic Patients: Prospective Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.