Spinal Cord InjuriesFALMINCT03962218
Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries
A study testing aquatic physiotherapy in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- aquatic physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with progressive injuries.
- heart or lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.
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 .
Read more
Secondary objectives:
- functional gait
- To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.
- To study the effect of aquatic therapy on serum markers of systemic inflammation.
- 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
- Being tested
- aquatic physiotherapy
- Keywords
- spinal cord injury, Hydrotherapy, Balance, Gait
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic physiotherapyProcedure or surgery
Also called hydrotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Aquatic Therapy (EAT) | Experimental | Aquatic physiotherapy treatment at time 1 (week 1) Receives: Procedure: aquatic physiotherapy |
| Late Aquatic Therapy (LAT) | Other | Control for Group 1 for the 5 first weeks of Group 1 treatment. Aquatic physiotherapy treatment at time 2 (week 6). Receives: Procedure: aquatic physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
Berg test
Measured: 12 weeks
Speed of the gait
test of 10 m
Measured: 12 weeks
Gait resistance
6 Minutes Walk Test
Measured: 12 weeks
Functional capacity of the gait
Walking Index for spinal cord injury (WISCI II)
Measured: 12 weeks
Secondary outcomes (3)
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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-1α, IL-1β, IL-10, MCP-1 (CCL2),GM-CSF, IL12p70, MIP-1α (CCL3), MIP-1β (CCL4), ICAM-1, IL-4, IL-13, IFN-α, IFN-γ, IL-6, IL-17A,(CTLA8), IL-8 (CXCL8), IP-10 (CXCL10) and TNF-α.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Jan 2020
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inés Martínez-Galán, MD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962218
- Sponsor's protocol ID
- ECA-FALMI-19
- Acronym
- FALMI
- Status last verified
- Apr 2024
- First submitted
- 14 May 2019
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Nov;48(6):997-1005. doi: 10.1080/10790268.2025.2472098. Epub 2025 Mar 31.
PubMed 40163138
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.
- ClinicalTrials.gov ID
- NCT03962218
- Acronym / sponsor ID
- FALMI / ECA-FALMI-19
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, Hydrotherapy, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- functional gait
- To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.
- To study the effect of aquatic therapy on serum markers of systemic inflammation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Aquatic Therapy (EAT) | Experimental | Procedure: aquatic physiotherapyAquatic physiotherapy treatment at time 1 (week 1) |
| Late Aquatic Therapy (LAT) | Other | Procedure: aquatic physiotherapyControl for Group 1 for the 5 first weeks of Group 1 treatment. Aquatic physiotherapy treatment at time 2 (week 6). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with progressive injuries.
- heart or lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aquatic physiotherapyAlso: hydrotherapyspecific 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. | Procedure or surgery | Early Aquatic Therapy (EAT), Late Aquatic Therapy (LAT) |
Primary outcome
balance
Time frame: 12 weeks
Berg test
Speed of the gait
Time frame: 12 weeks
test of 10 m
Gait resistance
Time frame: 12 weeks
6 Minutes Walk Test
Functional capacity of the gait
Time frame: 12 weeks
Walking Index for spinal cord injury (WISCI II)
3 secondary outcomes
General quality of life related to Health
Time frame: 12 weeks
Specific quality of life related to health in spinal cord injury
Time frame: 12 weeks
Inflammatory cytokines analysis
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 40163138Menchero 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 Nov;48(6):997-1005. doi: 10.1080/10790268.2025.2472098. Epub 2025 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inés Martínez-Galán, MD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic physiotherapy in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.