Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000044426
Ethics application status
Approved
Date submitted
26/11/2015
Date registered
19/01/2016
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Specialized Physiotherapy Intervention in Patients with Amyotrophic Lateral Sclerosis from the beginning of the disease. Influence of this intervention on functional status, respiratory function, quality of life and hospitalization rate.
Scientific title
‘An early specialized physiotherapy intervention: influence on functional status, respiratory function, respiratory complication and hospitalization rate in Patients with Amyotrophic Lateral Sclerosis’
Secondary ID [1] 288016 0
'Nil know'
Universal Trial Number (UTN)
U1111-1176-7865
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 296889 0
Condition category
Condition code
Neurological 297116 297116 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 297534 297534 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An individual sixty minutes intervention of Physiotherapy one per week from the beginning of the disease until the death of the patient.The intervention covers the whole group of deteriorated functions that each patient has:
- Chest physiotherapy to increase or preserve the pulmonary function: re-education of respiratory patterns, use of a volume-oriented device, use of manually assisted and unassisted coughing techniques and finally, use of a cough-assist device.
- Conventional Physiotherapy to preserve the ability to walk, the physical balance and the aerobic capacity: Static Cycle Bike for hands and legs, treadmill with suspension system to preserve the walk function and vibratory platform (Zeptor).
- Conventional Physiotherapy to preserve the whole range of movements: active and passive mobilization, manual therapy as well as stretching.
- Manual Therapy and Kinesiotaping to prevent the pain.
-Electro-stimulation in the swallowing muscles to preserve the swallowing and speech ability.
Intervention code [1] 293345 0
Rehabilitation
Intervention code [2] 293654 0
Treatment: Other
Comparator / control treatment
"No treatment"
Control group
Active

Outcomes
Primary outcome [1] 296735 0
Forced Vital Capacity assessed by Spirometry WelchAllyn
Timepoint [1] 296735 0
Before the intervention and every month during the intervention
Primary outcome [2] 296736 0
Forced Espiratory Volume assessed by Spirometry WelchAllyn
Timepoint [2] 296736 0
Before the intervention and every month during the intervention
Primary outcome [3] 296737 0
Walking assessed by GAITRiter Systems
Timepoint [3] 296737 0
Before the intervention and every month during the intervention
Secondary outcome [1] 319210 0
Quality of life assessed with the Revised Amyotrophic Lateral Sclerosis Functional Rating scale and with the Modified Barthel Index by Granger
Timepoint [1] 319210 0
Before the intervention and every month during the intervention
Secondary outcome [2] 319211 0
Number of Pulmonary Complication assessed with verbal self-report by participant at monthly assessment
Timepoint [2] 319211 0
Before the intervention and every month during the intervention
Secondary outcome [3] 319212 0
Rate of Hospitalization assessed by review of hospital records.
Timepoint [3] 319212 0
Before the intervention and every month during the intervention
Secondary outcome [4] 319213 0
Peak Flow assessed by peak flow meter (Inaladuo).
Timepoint [4] 319213 0
Before the intervention and every month during the intervention
Secondary outcome [5] 319214 0
Oxygen saturation assessed by pulse oximeter (Quirumed)
Timepoint [5] 319214 0
Before the intervention and every month during the intervention
Secondary outcome [6] 319215 0
Muscle activity assesses by Superficial Electromyography assessed by Neurotrac ETS
Timepoint [6] 319215 0
Before the intervention and every month during the intervention
Secondary outcome [7] 319216 0
Pain assessed by McGill Pain Questionnaire
Timepoint [7] 319216 0
Before the intervention and every month during the intervention

Eligibility
Key inclusion criteria
Key Inclusion Criteria were: diagnosis of ELA established by El Escorial criteria, including in the category of definite or probable; ability and willing to comply with the study procedures and the follow-up requirements; given written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The Exclusion Criteria were: severe unstable medical condiction (with possibility of life threatening complications), fronto-temporal’s dementia; no ability and not willing to comply with the study procedures and follow-up requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The experimental group is composed by all the subjects diagnosed Amyotrophic Lateral Sclerosis of Hospital Virgen Macarena who can attend the Neurorehabilitation’s Unit.

The control group is composed by subjects with Amyotrophic Lateral Sclerosis’s diagnostic who can not attend on the aforementioned Unit due to demographic, geographic, social’s reasons.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is 30, calculated by nQuery Advisor Program. Test significant level 0,050, effect size 0,885, power 90%

Statistical Analysis is going to be performed by PASW STATISTIC 18 for window.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
2/01/2012
Date of last participant enrolment
Anticipated
1/02/2012
Actual
1/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 7379 0
Spain
State/province [1] 7379 0
Andalucia/Sevilla

Funding & Sponsors
Funding source category [1] 292466 0
Hospital
Name [1] 292466 0
Hospital Virgen Macarena
Country [1] 292466 0
Spain
Primary sponsor type
Hospital
Name
Hospital Virgen Macarena
Address
Avenida Doctor Frediani 3, 41071, Seville
Country
Spain
Secondary sponsor category [1] 291167 0
None
Name [1] 291167 0
Address [1] 291167 0
Country [1] 291167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293932 0
Comite di Etica de Investigacion (CEI) de centro Hospital Universitario Virgen Macarena.
Ethics committee address [1] 293932 0
Ethics committee country [1] 293932 0
Spain
Date submitted for ethics approval [1] 293932 0
15/07/2011
Approval date [1] 293932 0
27/07/2011
Ethics approval number [1] 293932 0
1660

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

Contacts
Principal investigator
Name 61846 0
Mrs Anja Hochsprung
Address 61846 0
Hospital Virgen Macarena
Calle Doctor Frediani 3, planta septima C 41003
Seville
Country 61846 0
Spain
Phone 61846 0
+34 671562074
Fax 61846 0
Email 61846 0
[email protected]
Contact person for public queries
Name 61847 0
Anja Hochsprung
Address 61847 0
Hospital Virgen Macarena
Avenida Doctor Frediani 3,planta septima C, 41003
Seville
Country 61847 0
Spain
Phone 61847 0
+34 671562074
Fax 61847 0
Email 61847 0
[email protected]
Contact person for scientific queries
Name 61848 0
Anja Hochsprung
Address 61848 0
Hospital Virgen Macarena
Avenida Doctor Frediani 3, planta septima C, 41003
Seville
Country 61848 0
Spain
Phone 61848 0
+34 671562074
Fax 61848 0
Email 61848 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.