NCT02316067

Brief Summary

The purpose of this study was to evaluate the effects of an exercise program proposed by the CHORDATA® Method on the functionality, maximal isometric torque, muscle activity and muscle thickness of trunk muscles in patients with traumatic spinal cord injury. The hypothesis is that the CHORDATA® Method could reduce the deleterious effects of the traumatic spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 8, 2014

Last Update Submit

December 9, 2014

Conditions

Keywords

Spinal cordWounds and InjuriesRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Torque change ( assessed by dynamometry.)

    Torque is an expression of the muscular strength and was assessed by dynamometry.

    Torque was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).

Secondary Outcomes (1)

  • Muscular electrical activation change (assessed by electromyography (EMG)

    Muscular electrical activation was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).

Other Outcomes (2)

  • Muscle thickness change (assessed by ultrasonography)

    Muscle thickness was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).

  • Functional performance change (assessed by Functional Reach Adapted Test)

    Functional performace was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).

Study Arms (2)

Rehabilitation

EXPERIMENTAL

Eight weeks of rehabilitation (CHORDATA® Method)

Other: Rehabilitation

Control

NO INTERVENTION

Participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period.

Interventions

The CHORDATA® Method (16 sessions; 50 minutes each; twice a week) consisted of three exercises: (1) anterior pendulum, with the patient seated on a chair, upper limb suspended by springs and straps, and actively moving the trunk forward; (2) posterior pendulum exercise, on a similar position as exercise (1) but now moving the trunk backwards and recruiting the abdominal wall muscles during a posterior pelvic tilt motion; and (3) stand-up and sit-down exercise, patient with knees fixed anteriorly, initiating the standing-up movement by pulling back and down the springs, trying to maintain the standing position for as long as possible, balancing the trunk and transferring the supporting force from the upper limbs to the lower limbs.

Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • \- Patients that suffered traumatic spinal cord injury in the last 42 months, capable of transporting themselves for rehabilitation at the physical therapy clinic and for the neuromuscular tests at the laboratory where measurements were performed.

You may not qualify if:

  • Body weight above 95kg
  • Physical and functional limitations impeding them of performing physical activity
  • Physically incapacitating diseases (e.g severe cardiovascular and respiratory diseases, neurodegenerative diseases, oncologic diseases, systemic arterial hypertension)
  • Visual deficit that impeded reading
  • Recurrent vertigo or hypotension to exercise
  • Engaged in other treatments that could constitute a confounding effect
  • Changed their daily life activities during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (1)

  • Frison VB, Lanferdini FJ, Geremia JM, de Oliveira CB, Radaelli R, Netto CA, Franco AR, Vaz MA. Effect of corporal suspension and pendulum exercises on neuromuscular properties and functionality in patients with medullar thoracic injury. Clin Biomech (Bristol). 2019 Mar;63:214-220. doi: 10.1016/j.clinbiomech.2019.02.012. Epub 2019 Feb 23.

MeSH Terms

Conditions

Spinal Cord InjuriesWounds and Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous System

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Carlos A Netto, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 12, 2014

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations