Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises

Spinal Cord Injuries Clinical Trial

Official title:

Effect of Corporal Suspension and Pendulum Exercises on Torque, Muscle Activation, Muscle Thickness and Functionality in Patients With Traumatic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316067
• Other study ID #: UFRGS - 70254
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: December 9, 2014
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Other:
• Rehabilitation
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.

Locations

Country	Name	City	State
Brazil	Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Marco Aurélio Vaz, PhD	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle thickness change (assessed by ultrasonography)	Muscle thickness was 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).	Yes
Other	Functional performance change (assessed by Functional Reach Adapted Test)	Functional performance was 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).	Yes
Primary	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).	Yes
Secondary	Muscular electrical activation change (assessed by electromyography (EMG)	Electrical activation was 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).	Yes