NCT04360447

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 22, 2020

Last Update Submit

April 22, 2020

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuriesreformer pilateshome exercise

Outcome Measures

Primary Outcomes (1)

  • the upper extremity muscle strength

    measure the upper extremity muscle strength with a hand dynamometer

    8 weeks

Secondary Outcomes (2)

  • the Short Form(36) Health Survey (SF-36)

    8 weeks

  • Spinal Cord Independence Measure version III (SCIM-III)

    8 weeks

Study Arms (2)

Reformer pilates group

EXPERIMENTAL

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

Device: Reformer Pilates

Home exercise group

ACTIVE COMPARATOR

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

Other: Home Exercise

Interventions

Reformer PilatesDEVICE

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

Reformer pilates group
Home ExerciseOTHER

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

Home exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 24614829BACKGROUND

  • 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.

    PMID: 27002667BACKGROUND

  • 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.

    PMID: 16554684BACKGROUND

  • 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.

    PMID: 22330108BACKGROUND

  • 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.

    PMID: 12851498BACKGROUND

  • 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.

    PMID: 15456347BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Fatma N Kesiktaş, Assoc. Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

TU(1)