Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Spinal Cord Injuries

Clinical Trial Details

NCT number	NCT03962218
Study type	Interventional
Source	University of Castilla-La Mancha
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2020
Completion date	November 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries — FALMI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms