Spinal Cord InjuriesNCT02316067
Traumatic Spinal Cord Injury: Effects of Corporal Suspension and Pendulum Exercises
A study testing Rehabilitation in people with Spinal Cord Injuries, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Effect of Corporal Suspension and Pendulum Exercises on Torque, Muscle Activation, Muscle Thickness and Functionality in Patients With Traumatic Spinal Cord Injury
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.
Read the 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
- Conditions
- Spinal Cord Injuries
- Being tested
- Rehabilitation
- Keywords
- Spinal cord, Wounds and Injuries, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | Eight weeks of rehabilitation (CHORDATA® Method) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque change ( assessed by dynamometry.)
Torque is an expression of the muscular strength and was assessed by dynamometry.
Measured: 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)
Electrical activation was assessed by electromyography (EMG).
Measured: Muscular electrical activation was measured 2 times during the study: Pre-intervention/control and post-intervention/control (8 weeks after the first assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Aurélio Vaz, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor-investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Carlos A Netto, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316067
- Sponsor's protocol ID
- UFRGS - 70254
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30952032
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Corporal Suspension and Pendulum Exercises on Torque, Muscle Activation, Muscle Thickness and Functionality in Patients With Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02316067
- Acronym / sponsor ID
- UFRGS - 70254
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord, Wounds and Injuries, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Marco Aurélio Vaz, PhDUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Other: RehabilitationEight weeks of rehabilitation (CHORDATA® Method) |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe 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. | Other | Rehabilitation |
Primary outcome
Torque change ( 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).
Torque is an expression of the muscular strength and was assessed by dynamometry.
1 secondary outcome
Muscular electrical activation change (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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Derived from this study: PubMed 30952032Frison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Netto, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Spinal Cord Injuries, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Torque change ( 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.