NCT03962218

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. 1.functional gait
  2. 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. 3.To study the effect of aquatic therapy on serum markers of systemic inflammation.
  4. 4.Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

3.8 years

First QC Date

May 14, 2019

Last Update Submit

April 25, 2024

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuryHydrotherapyBalanceGait

Outcome Measures

Primary Outcomes (4)

  • balance

    Berg test

    12 weeks

  • Speed of the gait

    test of 10 m

    12 weeks

  • Gait resistance

    6 Minutes Walk Test

    12 weeks

  • Functional capacity of the gait

    Walking Index for spinal cord injury (WISCI II)

    12 weeks

Secondary Outcomes (3)

  • General quality of life related to Health

    12 weeks

  • Specific quality of life related to health in spinal cord injury

    12 weeks

  • Inflammatory cytokines analysis

    12 weeks

Study Arms (2)

Early Aquatic Therapy (EAT)

EXPERIMENTAL

Aquatic physiotherapy treatment at time 1 (week 1)

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).

Procedure: aquatic physiotherapy

Interventions

aquatic physiotherapyPROCEDURE

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.

Also known as: hydrotherapy
Early Aquatic Therapy (EAT)Late Aquatic Therapy (LAT)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with progressive injuries.
  • heart or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional de Parapléjicos

Toledo, 45071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 40163138DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Inés Martínez-Galán, MD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 23, 2019

Study Start

January 1, 2020

Primary Completion

October 30, 2023

Study Completion

November 30, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

ES(1)