Back to resultsTraumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord, Wounds and Injuries, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rehabilitation
Control
Arm Description
Eight weeks of rehabilitation (CHORDATA® Method)
Participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period.
Outcomes
Primary Outcome Measures
Torque change ( assessed by dynamometry.)
Torque is an expression of the muscular strength and was assessed by dynamometry.
Secondary Outcome Measures
Muscular electrical activation change (assessed by electromyography (EMG)
Electrical activation was assessed by electromyography (EMG).
Full Information
NCT ID
NCT02316067
First Posted
December 8, 2014
Last Updated
December 9, 2014
Sponsor
Marco Aurélio Vaz, PhD
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02316067
Brief Title
Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises
Official Title
Effect of Corporal Suspension and Pendulum Exercises on Torque, Muscle Activation, Muscle Thickness and Functionality in Patients With Traumatic Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Aurélio Vaz, PhD
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Participants were allocated into one of two groups (rehabilitation or control). Rehabilitation group (8 weeks of rehabilitation; CHORDATA® Method) Control group (patients with up to three years of traumatic spinal cord injury): Participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period. At the end of the control period, patients interested at participating on the training program were included in the intervention group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal cord, Wounds and Injuries, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation
Arm Type
Experimental
Arm Description
Eight weeks of rehabilitation (CHORDATA® Method)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Torque change ( assessed by dynamometry.)
Description
Torque is an expression of the muscular strength and was assessed by dynamometry.
Time Frame
Torque was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).
Secondary Outcome Measure Information:
Title
Muscular electrical activation change (assessed by electromyography (EMG)
Description
Electrical activation was assessed by electromyography (EMG).
Time Frame
Muscular electrical activation was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).
Other Pre-specified Outcome Measures:
Title
Muscle thickness change (assessed by ultrasonography)
Description
Muscle thickness was assessed by ultrasonography
Time Frame
Muscle thickness was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).
Title
Functional performance change (assessed by Functional Reach Adapted Test)
Description
Functional performance was assessed by Functional Reach Adapted Test
Time Frame
Functional performace was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos A Netto, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90690-200
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
30952032
Citation
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, Avon). 2019 Mar;63:214-220. doi: 10.1016/j.clinbiomech.2019.02.012. Epub 2019 Feb 23.
Results Reference
derived
Learn more about this trial
Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises
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