Clinical trial NCT03962218: Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries
Official title: Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
Hydrotherapy
Balance
Gait
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: balance
timeFrame: 12 weeks
measure: Speed of the gait
timeFrame: 12 weeks
measure: Gait resistance
timeFrame: 12 weeks
measure: Functional capacity of the gait
timeFrame: 12 weeks
Secondary outcomes:
measure: General quality of life related to Health
timeFrame: 12 weeks
measure: Specific quality of life related to health in spinal cord injury
timeFrame: 12 weeks
measure: Inflammatory cytokines analysis
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos
Study officials:
affiliation: University of Castilla-La Mancha
name: Inés Martínez-Galán, MD
role: PRINCIPAL_INVESTIGATOR
References: