Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries (FALMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03962218
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Castilla-La Mancha

Brief Summary:

Purpose of the study: To analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (LMi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life.

Main objective: To analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level T1-L5 and ASIA (American Spinal Injury Association) C and D .

Secondary objectives:

  1. functional gait
  2. To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.
  3. To study the effect of aquatic therapy on serum markers of systemic inflammation.
  4. Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables.

Scope of the study: National Hospital of Paraplegics. Toledo (Spain). Population: Subjects with incomplete spinal cord injury ASIA C and D. n = 50 (25 in each arm randomly).

Intervention:

6 weeks of specific Aquatic Physiotherapy (3 times a week). Group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later.

Outcomes: Static and dynamic balance (Berg test and Time Up and Go). Speed of the gait (test of 10 m.). Gait resistance (6 min. Test). Functional capacity of the gait (WISCI II). Biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. Questionnaires EuroQol-5Dimensions-5Level (EQ-5D-5L) and the Spanish Version of the Quality of Life Index (SV-QLI) in spinal cord injury (SCI).

Biomarkers of inflammation: 20 cytokines. Analysis of results: The main outcome measure will be the percentage of patients who have improved. Considering improvement when the difference between the groups is, at least, a 10% of their score in the Berg test between V0 and V1 (with their corresponding 95% confidence intervals). It will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. All analyses will be performed according to the intention to treat principle.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Procedure: aquatic physiotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Aquatic Therapy (EAT)
Aquatic physiotherapy treatment at time 1 (week 1)
Procedure: aquatic physiotherapy
specific aquatic physiotherapy 3 times a week, for 6 weeks, including feet balance exercises (Rating of Perceived Effort (RPE)), slow walking in all directions, walking with obstacles, Ai Chi, exercises of muscular strength. Each session duration is of 40 minutes.
Other Name: hydrotherapy

Late Aquatic Therapy (LAT)
Control for Group 1 for the 5 first weeks of Group 1 treatment. Aquatic physiotherapy treatment at time 2 (week 6).
Procedure: aquatic physiotherapy
specific aquatic physiotherapy 3 times a week, for 6 weeks, including feet balance exercises (Rating of Perceived Effort (RPE)), slow walking in all directions, walking with obstacles, Ai Chi, exercises of muscular strength. Each session duration is of 40 minutes.
Other Name: hydrotherapy




Primary Outcome Measures :
  1. balance [ Time Frame: 12 weeks ]
    Berg test

  2. Speed of the gait [ Time Frame: 12 weeks ]
    test of 10 m

  3. Gait resistance [ Time Frame: 12 weeks ]
    6 Minutes Walk Test

  4. Functional capacity of the gait [ Time Frame: 12 weeks ]
    Walking Index for spinal cord injury (WISCI II)


Secondary Outcome Measures :
  1. General quality of life related to Health [ Time Frame: 12 weeks ]
    Measures through the Questionnaire EuroQol-5D-5L. The questionnaire comprises 5 dimensions: mobility, self care, usual activities, pain discomfort, anxiety/depression. Each dimension is scored in 5 levels, 1-5 (level 1-no problem, level 5,-extreme problems). Based on the answers, a index value from 0 to 1 is calculated (0-the worst quality of life, 1-the best quality of life).

  2. Specific quality of life related to health in spinal cord injury [ Time Frame: 12 weeks ]
    Measured through the questionnaire "Spanish version of the Quality of Life Index in spinal cord injury (SV-QLI / SCI)". The questionnaire evaluates 37 items, in a scale from 1 (less satisfied) to 6 (most satisfied). There are 5 scores of 0-30 (0=less satisfied, 30=most satisfied) which are calculated using the subscales: 1-Total Quality of Life score. 2-Health and Functioning Subscale. 3-Social and Economic Subscale. 4-Psychological /Spiritual Subscale. 5-Family Subscale. The final score is an average of the subscale's scores, being between 0 (0=less satisfied) and 30 (30=most satisfied).

  3. Inflammatory cytokines analysis [ Time Frame: 12 weeks ]
    Quantification of the cytokine concentration, in pg/mL, will be carried out by Luminex xMAP Bead-based multiplex Assay (Labclinics). Cytokine's panel includes the cytokines E-selectin, P-selectin, IL-1α, IL-1β, IL-10, MCP-1 (CCL2),GM-CSF, IL12p70, MIP-1α (CCL3), MIP-1β (CCL4), ICAM-1, IL-4, IL-13, IFN-α, IFN-γ, IL-6, IL-17A,(CTLA8), IL-8 (CXCL8), IP-10 (CXCL10) and TNF-α.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with incomplete spinal cord injury T1-L5 (ASIA C y D).
  • Traumatic and not traumatic injuries, with injury date of less than 8 months.
  • Able to maintain assisted standing up
  • Subjects signing the informed consent form

Exclusion Criteria:

  • Subjects with progressive injuries.
  • heart or lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962218


Contacts
Layout table for location contacts
Contact: Inés Martínez-Galán, MD +34 925268800 ext 5837 ines.martinez@uclm.es

Locations
Layout table for location information
Spain
Hospital Nacional de Parapléjicos Recruiting
Toledo, Spain, 45071
Contact: María Angeles Alcaráz Rousselet, Physician    +34 925 247700    maalcaraz@sescam.jccm.es   
Sponsors and Collaborators
University of Castilla-La Mancha
Investigators
Layout table for investigator information
Principal Investigator: Inés Martínez-Galán, MD University of Castilla-La Mancha

Layout table for additonal information
Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT03962218     History of Changes
Other Study ID Numbers: ECA-FALMI-19
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Castilla-La Mancha:
spinal cord injury
Hydrotherapy
Balance
Gait

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System