Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries (FALMI)

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Procedure: aquatic physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Hospital Nacional de Parapléjicos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: hydrotherapy
Other: 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 Names: hydrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
balance	Berg test	12 weeks
Speed of the gait	test of 10 m	12 weeks
Gait resistance	6 Minutes Walk Test	12 weeks
Functional capacity of the gait	Walking Index for spinal cord injury (WISCI II)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General quality of life related to Health	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).	12 weeks
Specific quality of life related to health in spinal cord injury	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).	12 weeks
Inflammatory cytokines analysis	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Investigators: Principal Investigator: Inés Martínez-Galán, MD, University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Gait; spinal cord injury; Hydrotherapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: ECA-FALMI-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No