Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

Spinal Cord Injuries Clinical Trial

— FALMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962218
• Other study ID #: ECA-FALMI-19
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Nacional de Parapléjicos	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	balance	Berg test	12 weeks
Primary	Speed of the gait	test of 10 m	12 weeks
Primary	Gait resistance	6 Minutes Walk Test	12 weeks
Primary	Functional capacity of the gait	Walking Index for spinal cord injury (WISCI II)	12 weeks
Secondary	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
Secondary	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
Secondary	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-1a, IL-1ß, IL-10, MCP-1 (CCL2),GM-CSF, IL12p70, MIP-1a (CCL3), MIP-1ß (CCL4), ICAM-1, IL-4, IL-13, IFN-a, IFN-?, IL-6, IL-17A,(CTLA8), IL-8 (CXCL8), IP-10 (CXCL10) and TNF-a.	12 weeks