Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

NCT ID: NCT03962218

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-11-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Aquatic Therapy (EAT)

Aquatic physiotherapy treatment at time 1 (week 1)

Group Type: EXPERIMENTAL

aquatic physiotherapy

Intervention Type: 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.

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).

Group Type: OTHER

aquatic physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

hydrotherapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inés Martínez-Galán, MD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Locations

Hospital Nacional de Parapléjicos

Toledo, , Spain

Countries

Spain

References

Menchero R, Martinez-Galan I, Alcobendas-Maestro M, Romay-Barrero H, Fernandez-Maestra A, Gueita-Rodriguez J. Feasibility and impact of a Water Specific Therapy program in individuals with subacute incomplete spinal cord injury: A non-randomized controlled trial. J Spinal Cord Med. 2025 Mar 31:1-9. doi: 10.1080/10790268.2025.2472098. Online ahead of print.

Reference Type: DERIVED

PMID: 40163138 (View on PubMed)

Other Identifiers

ECA-FALMI-19

Identifier Type: -

Identifier Source: org_study_id