Kayak Ergometer Training in Individuals With Spinal Cord Injury

NCT03531164 | Recruiting DMC

• 1 other identifier: 74/15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuries; kayak; trunk control

Outcome Measures

Primary Outcomes (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

  6 weeks

Secondary Outcomes (12)

• Spinal Cord Injury Independence Measure III

  Before training

• Spinal Cord Injury Independence Measure III

  6 weeks

• Cardiac frequency

  Before training

• Cardiac frequency

  6 weeks

• Arterial tension

  Before training

Study Arms (2)

Kayak ergometer group

EXPERIMENTAL

Intervention: 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.

Other: kAYAK ERGOMETER GROUP

Control group

ACTIVE COMPARATOR

Intervention: 30 minutes of proprioceptive neurofacilitation focused on trunk control

Other: CONTROL GROUP

Interventions

kAYAK ERGOMETER GROUP OTHER

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.

Kayak ergometer group

CONTROL GROUP OTHER

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

Control group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Instituto Nacional de Rehabilitacion

Mexico City, Mexico

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• JImena Quinzaños, MD, MSc

  Instituto Nacional de Rehabilitacion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimena Quinzaños, MD, MSc

CONTACT

+525559991000; jquinzanos@inr.gob.mx

Ivett Quiñones, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: May 21, 2018
• Study Start: April 1, 2016
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After january 2022 for 5 years
• Access Criteria: Ask the authors directly by mail

Locations

ME (1)