NCT04168164

Brief Summary

The aim of this study is to compare the relative effectiveness of three different treatment groups for improvements of postural control and for improvements of balance in these patients using aquatic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

Study Start

First participant enrolled

January 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 13, 2019

Last Update Submit

November 15, 2019

Conditions

Keywords

aquatic therapy; balance; acquired brain injury.

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale

    The test consists of sitting, getting up, maintaining the standing position and changing positions, with a total of 14 items. The total possible score is 56 points, The scores on the Berg balance scale were classified as follows: high risk of falls (0-20), moderate risk (21-40) and low risk (\> 41) with higher scores indicating that the person has better balance.

    6 months

  • Five Times Sit-to-Stand test

    The participants were seated with their arms crossed and they were asked to stand up and sit down five times as fast as possible

    6 months

Study Arms (1)

Ai Chi

EXPERIMENTAL

Ai Chi aquatic therapy Dry land therapy

Other: aquatic therapyOther: Dry land therapyOther: Combined therapy

Interventions

The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.

Ai Chi

sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs

Ai Chi

alternate sessions of therapy on dry land and aquatic therapy with Ai Chi

Ai Chi

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of acquired brain injury traumatic or non-traumatic, with over one year's evolution
  • the ability to walk independently over a distance of more than 10 meters, with or without an orthopedic aid
  • scores on the Mini- Mental State Examination \> 24

You may not qualify if:

  • cardiovascular and/or respiratory problems, a previous history of neurological pathologiesand the presence of coadjuvants to the acquired brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sagrario

Almería, 04120, Spain

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Aquatic TherapyPsychotherapy, Multiple

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sagrario Pérez- de la Cruz, Ph D

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This study was a randomized, single-blinded controlled trial. The participants were recruited from three brain injury associations and those who fulfilled the inclusion criteria were randomly assigned to three treatment groups.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 19, 2019

Study Start

January 7, 2018

Primary Completion

June 1, 2018

Study Completion

September 30, 2018

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations