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Completed

NCT Number: NCT03962218

Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nacional de Parapléjicos

Toledo, 45071, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aquatic physiotherapy

Procedure

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 names: hydrotherapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.

Acronym: FALMI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 23, 2019
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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