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Spinal Cord InjuriesNCT03531164

Kayak Ergometer Training in Individuals With Spinal Cord Injury

A study testing kAYAK ERGOMETER GROUP in people with Spinal Cord Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

One of the main objectives in spinal cord injury rehabilitation programs is the improvement of trunk control in order to achieve independence, to prevent complications and, in specific cases to walk. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
kAYAK ERGOMETER GROUP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteMexico
Study dates
Apr 2016to Sep 2024
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of spinal cord injury with any American Spinal Injury Association Impairment Scale (AIS) classification
  • Neurologic level below C8
  • Time since injury form 3 to 12 months
  • Any aetiology

Who cannot join

  • Another neurologic diagnosis
  • Sense organ alteration
  • Orthopaedic problem that interferes with training
  • Alteration in superior mental function
  • Cardiovascular or metabolic disease that interferes with trainig

Trial locations and contacts

1 site in 1 country.

Jimena Quinzaños, MD, MSc contact

+525559991000 ext. 13410

jquinzanos@inr.gob.mx

Ivett Quiñones, PhD contact

Mexico1 site, 1 recruiting
  • Instituto Nacional de Rehabilitacion

    Mexico City

    Jimena Quinzaños, MD MSc, 01525559991000 ext. 13410, jimenaqf@hotmail.com

    Ivett Quiñones, PhD, 01525559991000 ext. 19606, iquinonesu@yahoo.com.mx

    Recruiting

Other trials in Mexico

About this study

Official title: Effect of Kayak Ergometer Training in Trunk Control, Independence and Cardiovascular Health in Individuals With Spinal Cord Injury

One of the main objectives in spinal cord injury rehabilitation programs is the improvement of trunk control in order to achieve independence, to prevent complications and, in specific cases to walk.

Research question: What is the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury? Purpose: To determine the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury.

Read more

Methods: Randomized clinical trial, blinded to evaluator and to the person that will analyze data.

Population: Spinal cord injured individuals treated at the National Institute of Rehabilitation, with a spinal cord injury of any ethiology, with a neurologic level of C8 and below, with time since injury from three months to one year.

Proceeding: The subjects will be randomly assigned to : a control group with neuro propioceptive facilitation exercises focused in trunk control or an experimental group with kayak ergometer training. Both groups will recieve 5 sessions a week during 6 weeks.

Read the detailed description

Spinal Cord Injury (SCI) is an alteration of the spinal cord that modifies not only muscular strength and sensitivity, but that also generates a change in all of the systems of the organism. At the worldwide level, an incidence is calculated of between 13.1 and 52.2 per one million inhabitants.

Damage to the ascending and descending tracts of the spinal cord consequently gives rise to an alteration in the postural control system. It is known that effective postural control is of utmost importance forstanding and walking, as well as for providing support for voluntary movements. Alterations in posture depend on the grade and level of the injury; thus, persons with complete, thoracic, or cervical lesions have poor trunk control. Due to the latter, they are limited in many of the movements necessary for carrying out daily life activities (DALYS) Therefore, part of the objectives of rehabilitation in individuals with an SCI comprises improvement in trunk control.

On the other hand, patients with SCI tend to engage in a sedentary lifestyle that, added to the alterations in the autonomic nervous system proper to the lesion, exposes individuals with a SCI to a greater risk of developing chronic-degenerative conditions, such as metabolic syndrome and cardiovascular diseases, which are, at present, the main cause of death in these persons.

Thus, after the immediate rehabilitation, it is necessary to maintain and improve the functional capacity obtained during this process. Therefore, it is important to find training activities to challenge stabilization of the upper part of the body and sitting equilibrium without giving rise to symptoms caused by overuse.

Kayak training appears to comply with these criteria, in that it implicates the greater part of the upper musculature, presents high metabolic demands, and imposes strict requirements for the balance control system, due to continuous compensation of the disturbances of the upper part of the body caused by movement on the apparatus. It was previously demonstrated that open-sea training in kayaks could be implemented in a group of individuals in paraplegic condition and that this is accompanied by improvements in strength and equilibrium in sedestatIon.

Due to the difficulty in controlling and adjusting the time and challenge level of the equilibrium experienced by participants at sub-acute stages, it is necessary to utilize a kayak ergometer, in such a way that the demand for equilibrium can be adjusted individually and for this to increase progressively as the treatment advances. In this respect, Bjerkefors and Thorstensson demonstrated that kayak ergometer training in a group of persons with SCI is accompanied by improvement in shoulder muscular strength and in various functional wheelchair tests that demand trunk stabilization and balance control.

These studies achieved demonstrating the positive effect of kayak training in patients with SCI; however, in these studies, small populations were included (10 and 12 individuals), with chronic-stage lesions, and the effects on trunk control were not evaluated by means of a validated scale in this population, nor were the training's effects on cardiovascular function and functional independence.

To date, the effect of kayak ergometer training has not, to our knowledge, been studied in individuals with SCI in terms of trunk control with tools validated for persons with SCI, regarding the cardiovascular condition, functional independence, and quality of life, thus engendering the need to conduct this present study.

HYPOTHESIS

Kayak ergometer training will improve functional independence, trunk control, and cardiovascular condition in individuals with SCI.

The effect of training with the kayak ergometer on functional independence, trunk control, and the cardiovascular condition in individuals with SCI will be greater than that of conventional trunk-control training.

GENERAL OBJECTIVE

To determine the effect of kayak ergometer training in patients with SCI in functionality, trunk control, cardiovascular condition, and quality of life.

SPECIFIC OBJECTIVES

  • Establish the validity, reliability, error, and sensitivity of the measurement instrumented of trunk control in subjects with SCI.
  • Evaluate the existence of floor/ceiling effects in the instrumented assessment of trunk control.
  • Develop computerized tools for evaluation of trunk control that are easily applicable in daily clinical practice, with low-cost, practical, and simple technology for improving the exactness and reliability of the observational analysis, for rehabilitation centers that are not equipped with a movement-analysis laboratory, with sufficient information for evaluating the trunk control of the individual with SCI.
  • Proposal of a pilot program of trunk control rehabilitation in persons with SCI.
  • Broadcast preliminary results at a national scientific meeting.
  • Form human resources with knowledge of neurological rehabilitation, movement analysis, and biomedical engineering.
  • Foster multidisciplinary cooperation.

MATERIALS AND METHODS

Study type. Randomized controlled clinical trial blinded to the evaluator and to the person performing the data analysis.

Description of the work universe. Patients of out-patient consultations and hospitalization of the SCI Service of the National Institute of Rehabilitation), with a diagnosis of SCI of any etiology, with a neurological level of under C8, with a SCI of 3 months of evolution.

Definition of the control group Group A. Control group, management with conventional therapy for improvement of trunk control (proprioceptive neurofacilitation exercises focused on trunk control21) of 20 minutes five times weekly during 6 weeks.

Sample size We utilized the Epidat ver. 4 statistical software program to calculate sample size. For 80% study power and an alpha error probability of less than 0.05, and considering the work of Grigorenko and collaborators18 we found a frontal displacement speed difference of the Center of Pressure (CoP) of 0.1m/s with a Standard Deviation (SD) of 0.05 m/s between the experimental and the control group. Therefore, seven patients per group were required. Considering a possible loss of 20%, we will recruit nine patients per group.

Description of the study variables, units of measure, and measuring scales

Clinical and demographic variables

  • SCI severity: According to American Spinal Injury Association, with International standards for neurological classification of spinal cord injury modifications: complete, B: incomplete, preservation of only the sensitive function, C: incomplete, voluntary anal contraction or more than half of key muscles in <3, D: incomplete, more than half of the key muscles in >3, E: total recuperation A, B, C, D, E
  • Neurological level: More caudal segment of the SC with normal function
  • Time of evolution of the SCI:Time in days elapsed from when the SCI was produced until time of application of the questionnaire
  • Age:Years elapsed from date of birth to time of questionnaire application

Proposed statistical analysis

The investigators will utilize the Statistical Package for the Social Sciences ver. 17 statistical software program. The investigators will perform descriptive statistics with central-tendency measurements for quantitative variables and with proportions for qualitative variables. To determine differences between groups, analysis of covariance will be carried out. Results that are statistically significant with a p of <0.05 will be considered.

Being tested
kAYAK ERGOMETER GROUP, CONTROL GROUP
Keywords
spinal cord injuries, kayak, trunk control
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kAYAK ERGOMETER GROUPOther

    Kayak ergometer training for 30 min 5 times a week for 6 weeks. The training includes a warming (pre charge) during 3 minutes, a training (charge) characterised by 3-5 intervals with medium to high intensity during 2-4 minutes and pauses of 1-2 minutes between active phases and 2 minutes of cooling down (post charge) to complete 30 minutes of training.

  • CONTROL GROUPOther

    Proprioceptive neurofacilitation exercises focused in trunk control during 30 minutes 5 times a week for 6 weeks.

Study groups in NCT03531164
Study groupRoleWhat they receive
Kayak ergometer groupExperimentalIntervention: Training in kayak ergometer: 3 minutes of warming (pre-charge) , 3-5 intervals of training with moderate to high intensity and pauses of 2-4 minutes (charge) and 2 minutes of cooling down (post-charge) to complete 30 minutes.
Receives: Other: kAYAK ERGOMETER GROUP
Control groupActive comparatorIntervention: 30 minutes of proprioceptive neurofacilitation focused on trunk control
Receives: Other: CONTROL GROUP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trunk control

    Score between 0-24, cut-off point 13. Higher values represent better results. The clinical trunk control test for individuals with spinal cord injury will be used

    Measured: 6 weeks

Secondary outcomes (12)
  1. Spinal Cord Injury Independence Measure III

    Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.

    Measured: Before training

  2. Spinal Cord Injury Independence Measure III

    Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.

    Measured: 6 weeks

  3. Cardiac frequency

    Registered with a polar

    Measured: Before training

  4. Cardiac frequency

    Registered with a polar

    Measured: 6 weeks

  5. Arterial tension

    Registered with a sphygmomanometer

    Measured: Before training

  6. Arterial tension

    Registered with a sphygmomanometer

    Measured: 6 weeks

  7. Satisfaction with life

    Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.

    Measured: Before training

  8. Satisfaction with life

    Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.

    Measured: 6 weeks

  9. Metabolic Equivalent of Task

    Exercise tolerance test

    Measured: Before training

  10. Metabolic Equivalent of Task

    Exercise tolerance test

    Measured: 6 weeks

  11. Oxygen consumption

    Exercise tolerance test

    Measured: Before training

  12. Oxygen consumption

    Exercise tolerance test

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study startApr 2016
  3. Primary completionJun 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531164
Sponsor's protocol ID
74/15
Status last verified
May 2024
First submitted
5 Mar 2018
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data base whithout identificatiopns

Questions about this trial

What is this clinical trial studying?

A study testing kAYAK ERGOMETER GROUP in people with Spinal Cord Injuries, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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 Mexico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jimena Quinzaños, MD, MSc (+525559991000 ext. 13410, jquinzanos@inr.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trunk control (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 May 2024.

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