Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000492055
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
16/06/2010
Date last updated
16/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aquatic physiotherapy for vestibular rehabilitation in patients with unilateral vestibular hypofunction: comparative study
Scientific title
Aquatic physiotherapy for vestibular rehabilitation in patients with unilateral vestibular hypofunction: comparative study
Secondary ID [1] 251929 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unilateral vestibular hypofunction 257445 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257462 257462 0 0
Physiotherapy
Ear 257591 257591 0 0
Other ear disorders
Other 257662 257662 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the pacients receive nutricion orientation just once before the exercise protocol begin.

NUTRITION ORIENTATION

Eating well in the morning, less at lunch and much less at night, avoid keep themselves without food more than 3 hours
Avoid carbohydrates and refined sugars.
Use sweeteners like sucralose or stevia. Do not use aspartame.
Avoid pasta and fatty foods and products that increase the salt (Ajinomoto, soy sauce, seasonal, soup knor) ..
Eat slowly and chew food thoroughly.
Avoid alcohol and smoking.
Do not take more than three cups of coffee or black tea daily.
Drink water.
Do not take medicines without medical advice.
Sleep weel. Avoid excess.

After the nutrition orientation, the participants are randomised to undergo only one of these three types of rehabilitation (i.e. Aquatic Physiotherapy OR Cawthorne and Cooksey exercises OR Aquatic Relaxation exercises).

1) AQUATIC PHYSIOTHERAPY

Phase 1 Adaptation in the water The patient maintains the orthostatic posture with the aid of the physiotherapist at 1.30m depth.
Phase 2 Separation The patient maintains the upright position, at the same depth but without the therapist’s aid, maintaining the posture for 2 minutes.
Phase 3 Postural Transference From the sitting position on the stair step, the patient stands up and sits down, maintaining their support base, with the feet in parallel, comfortably separated, and touching the floor, but not the pool edge. Postural correction and respiratory orientation is performed when necessary.
Phase 4 Rotational Control of the Trunk In a sitting position, the patient performs maximum trunk rotation, without altering the sustaining base associated with arm flexion and abduction, crossing the median line at the water surface level and returning to the initial position.
Phase 5 Rotational control of the trunk associated with mobile target tracking The therapist throws a ball to the patient’s right and left sides. The patient must focus on the ball and follow its displacement in order to rebound it back along the same trajectory, using a combined movement of eyes and head, without altering the sustaining base.
Phase 6 Gait with thrust The patient experiences the buoyancy force in the water with the therapist’s aid, changing the level of body immersion, while respecting the patient’s height. The patient is released progressively until they achieve an independent gait (from 1.30 m to 1.50 m deep), back and forth, with eyes opened, eyes closed, head rotations and turbulence created by the therapist.
Phase 7 Up and Down the stairs The patient is instructed to go up and down the stairs to different heights with eyes opened, eyes closed, head rotation and with turbulence created by the therapist.
Phase 8 Sitting position on a float Sitting on a float, lower limbs free, the patient starts making sequential movement of pedaling, crossing arms at the median line at surface water level, eyes opened, eyes closed, head rotation and with the turbulence created by the therapist.
Phase 9 Sitting position on a float associated with mobile target tracking In the same position as the previous phase, the therapist throws the ball towards the patient’s right and left sides. The patient must focus on the ball and follow its movement to rebound it along the same trajectory, performing an associated movement with the eyes and head.
Phase 10 Upright buoyancy In the orthostatic position, wearing feet floats, the patient performs small jumping movements associated with crossing arms at the median line at surface water level, eyes opened, eyes closed, head rotation and with turbulence created by the therapist.
Phase 11 Upright buoyancy associated with mobile target tracking In the same position as the previous phase, the therapist throws the ball towards the patient’s right and left sides. The patient must focus on the ball and follows its displacement to rebound it along the same trajectory.
Phase 12 Control of movement with maximum turbulence In the orthostatic posture with a water jet aimed towards the patient, while performing up and down knee flexions for 5 minutes.

2) CAWTHORNE AND COOKSEY EXERCISES

A) Eye and head movement, sitting down – first slowly, than faster:
1) Look up and down;
2) Look tot the right and to the left;
3) Bring your fingers closer and farther, looking at it;
4) Move your head (slowly and then faster) to the right and to the left, with open eyes;
5) Move your head (slowly and then faster) up and down, with open eyes;
6) Repeat 4 and 5 with closed eyes.

B) Head and body movement, sitting down:
1) Place an object on the floor. Take it and bring it above your head and place it on the floor again (look at the object the whole time).
2) Shrink your shoulders and make circular movements;
3) Bend forward and take an object through the back and front of your knees.

C) Standing up exercises:
1) Repeat A and B2;
2) Sit down and stand up, sit down and stand up again;
1) Sit down and stand up; Sit down and stand up again with closed eyes;
2) Stand up, but turn to the right while standing;
3) Stand up, but turn to the left while standing;
4) Thow a small ball from one hand to the other (above the horizon level);
5) Thow a small ball from one hand to the other under your knees and alternatively.

Other activities to improve balance:
1) Clim up and downstairs (use handrail, if necessary);
2) Stand up and take sudden 90 degreesturns (first with open eyes, then with closed eyes);
3) While wlaking, look to the right and to the left (as if you were reading labels in the market;
4) Practice standing on one foot with the right foot then the left foot), first with open eyes, then with closed eyes;
5) Stand up, on a soft surface:
a) Walk on the surface to get used to it;
b) Walk on the tip of your feet first with open eyes, then with closed eyes;
c) Practice exercise 4 on a soft surface;
6) Circle around a person that is on the center that thows a large ball (wich should be thrown back);
7) Walk around the room cith closed eyes


3) AQUATIC RELAXATION EXERCISES

In the water the patient with the physiotherapist at 1.30m depth maintains the sitting position on the stair step, maintaining their support base, with the feet in parallel, comfortably separated. Postural correction and respiratory orientation is performed when necessary. Perform: with arm flexion and abduction, crossing the median line at the water surface level and returning to the initial position.
Arm flexion / extension.
Arm aduction / adduction.
Performs maximum trunk rotation, without any alteration of the sustaining base associated with arm abduction, cross the median line at the water surface level and return to the initial position.
Cross arms forward
With arm flexion and abduction, cross the median line at the water surface level and return to the initial position.
With arm flexion and abduction into the side right and left, to meet the other arm. r
Move to the side and arm forward.
The same anterior motion, associated with trunk rotation:
Extension an knee right at a time, with abduction of the arm right..
Extension an knee left at a time, with abduction of the arm left

Each one of the protocol exercise have this frequency and duration: 3 sessions per week in 40 minutes sessions;
overall duration: 10 sessions. For the first 3 weeks, 3 sessions a week, and then only 1 session in the final week to end the protocol.
mode of administration: one-on-one with a physiotherapist.
Intervention code [1] 256440 0
Rehabilitation
Intervention code [2] 256600 0
Treatment: Other
Comparator / control treatment
aquatic relaxation exercises: legs and arms moviments (abduction, adduction, flexion and extension), trunk rotation
Control group
Active

Outcomes
Primary outcome [1] 258509 0
The balance Rehabilitation Unit (BRU), a virtual reality system and force platform. The center of presure (COP) distribution area, determined using a confidence ellipse (CE), and the sway velocity (SV) under different visual conditions.
Timepoint [1] 258509 0
at the beginning and at the end of the rehabilitation, baseline and at 10 sessions on completion of rehabilitation program.
Secondary outcome [1] 264314 0
Brazilian version of the Dizziness Handicap Inventory, Analogical scale.
Timepoint [1] 264314 0
at the beginning and at the end of the rehabilitation, baseline and at 10 sessions on completion of rehabilitation program.

Eligibility
Key inclusion criteria
Adult patients aged from 20 to 60, who presented continuous complaints of chronic dizziness for periods longer than three months and with medical diagnosis of Unilateral Vestibular Hypofunction
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a clinical history of neurological, musculoskeletal, cardiovascular or pulmonary alterations. Also, exclusion criterion included poorly controlled hypertension and diabetes Mellitus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 2620 0
Brazil
State/province [1] 2620 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256932 0
University
Name [1] 256932 0
UNIFESP - Universidade Federal de Sao Paulo (Federal University of Sao Paulo)
Country [1] 256932 0
Brazil
Funding source category [2] 256933 0
University
Name [2] 256933 0
UNIFESP - Escola Paulista de Medicina
Country [2] 256933 0
Brazil
Primary sponsor type
Individual
Name
Yeda Pereira Lima Gabilan
Address
Alianca Liberal Street, 622 - Alto da Lapa - Sao Paulo, SP
CEP: 05088-000
Country
Brazil
Secondary sponsor category [1] 256293 0
None
Name [1] 256293 0
Address [1] 256293 0
Country [1] 256293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258936 0
UNIFESP Ethic and Research Departament
Ethics committee address [1] 258936 0
Ethics committee country [1] 258936 0
Brazil
Date submitted for ethics approval [1] 258936 0
Approval date [1] 258936 0
Ethics approval number [1] 258936 0
CEP 1581/06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31138 0
Address 31138 0
Country 31138 0
Phone 31138 0
Fax 31138 0
Email 31138 0
Contact person for public queries
Name 14385 0
Yeda Pereira Lima Gabilan
Address 14385 0
Alianca Liberal Street, 622, Alto da Lapa - Sao Paulo, SP
CEP: 05088-000
Country 14385 0
Brazil
Phone 14385 0
55 11 3831-9892
Fax 14385 0
Email 14385 0
[email protected]
Contact person for scientific queries
Name 5313 0
Yeda Pereira Lima Gabilan
Address 5313 0
Alianca Liberal Street, 622, Alto da Lapa - Sao Paulo, SP
CEP: 05088-000
Country 5313 0
Brazil
Phone 5313 0
55 11 3831-9892
Fax 5313 0
Email 5313 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.