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

NCT ID: NCT04360447

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Reformer pilates group

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

Group Type EXPERIMENTAL

Reformer Pilates

Intervention Type DEVICE

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

Home exercise group

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

Group Type ACTIVE_COMPARATOR

Home Exercise

Intervention Type OTHER

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

Interventions

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Reformer Pilates

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

Intervention Type DEVICE

Home Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatma N Kesiktaş, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dost G, Dulgeroglu D, Yildirim A, Ozgirgin N. The effects of upper extremity progressive resistance and endurance exercises in patients with spinal cord injury. J Back Musculoskelet Rehabil. 2014;27(4):419-26. doi: 10.3233/BMR-140462.

Reference Type BACKGROUND
PMID: 24614829 (View on PubMed)

Yildirim A, Surucu GD, Karamercan A, Gedik DE, Atci N, Dulgeroglu D, Ozgirgin N. Short-term effects of upper extremity circuit resistance training on muscle strength and functional independence in patients with paraplegia. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):817-823. doi: 10.3233/BMR-160694.

Reference Type BACKGROUND
PMID: 27002667 (View on PubMed)

Sipski ML, Richards JS. Spinal cord injury rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):310-42. doi: 10.1097/01.phm.0000202105.87011.bf. No abstract available.

Reference Type BACKGROUND
PMID: 16554684 (View on PubMed)

Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.

Reference Type BACKGROUND
PMID: 22330108 (View on PubMed)

Gibson KL. Caring for a patient who lives with a spinal cord injury. Nursing. 2003 Jul;33(7):36-41; quiz 42. doi: 10.1097/00152193-200307000-00031. No abstract available.

Reference Type BACKGROUND
PMID: 12851498 (View on PubMed)

Jacobs PL, Nash MS. Exercise recommendations for individuals with spinal cord injury. Sports Med. 2004;34(11):727-51. doi: 10.2165/00007256-200434110-00003.

Reference Type BACKGROUND
PMID: 15456347 (View on PubMed)

Other Identifiers

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IstPRMTRH

Identifier Type: -

Identifier Source: org_study_id

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