Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries (FALMI)

University of Castilla-La Mancha

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Procedure: aquatic physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03962218

ECA-FALMI-19

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Early Aquatic Therapy (EAT)

Experimental group

Description:

Aquatic physiotherapy treatment at time 1 (week 1)

Treatment:

Procedure: aquatic physiotherapy

Late Aquatic Therapy (LAT)

Other group

Description:

Control for Group 1 for the 5 first weeks of Group 1 treatment. Aquatic physiotherapy treatment at time 2 (week 6).

Treatment:

Procedure: aquatic physiotherapy