Aquatic Therapy in Patients With Adquired Brain Injury. | NCT04168164

Studies
Aquatic Therapy in Patients With Adquired Brain Injury.

NCT04168164

Sponsor

Universidad de Almeria

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Acquired Brain Injury

Interventions

aquatic therapy
Dry land therapy
Combined therapy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2018Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Nov 13, 2019

First Submission Date that Met QC Criteria

Nov 15, 2019

First Posted Date

Nov 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Forty-five patients diagnosed with acquired brain injury, with over one year's evolution and independent gait over a distance of 10 meters, with our without the use of an orthopedic aid, were selected and randomized in 3 groups. Dry land therapy group (DT group), which received sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs; Experimental group (EG group) , which received Ai Chi aquatic therapy; Combined group (DT+EG group), which received alternate sessions of therapy on dry land and aquatic therapy with Ai Chi.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ai Chi	Experimental	Ai Chi aquatic therapy Dry land therapy	Other: aquatic therapy Other: Dry land therapy Other: Combined therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aquatic therapy	Other	The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.	Ai Chi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sagrario Pérez- de la Cruz, Ph D	Universidad de Almeria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sagrario		Almería		04120	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000088543	Aquatic Therapy
D011616	Psychotherapy, Multiple

Ancestor Terms

ID	Term
D006875	Hydrotherapy
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided