Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001567112
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
13/11/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot single-factor controlled pilot study to determine the effect of a program of group circuit classes versus individualized attention for patients with motor sequelae produced by cerebral palsy
Scientific title
Pilot study of a single factor controlled to determine the effect of the motor component on the progress of a program of group circuit classes versus individualized attention for adult patients with motor sequelae produced by cerebral palsy
Secondary ID [1] 298099 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adults with cerebral palsy 312618 0
Condition category
Condition code
Neurological 311119 311119 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 311479 311479 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Descriptios of interventions:
a.- Physiotherapist Master in neurological therapy
b.- Groups of 5 people
c.- Moderate intensity. Scale borg
d.- 90-minute sessions twice a week
e.- Total duration of 12 weeks
f.- Initial and final evaluation. Record of daily training during the 12 weeks

First we will work on warm-up exercises (5 minutes): emotional stability and relationship building. A range of movement of the joint exercise and the stretching exercise of arms, legs and trunk.
Second, main exercise that sports activity on the march (60 minutes): improvement of body coordination and mobility, strengthening of strength, muscular endurance, weight support; standing postural control; The march includes, steps, ramps, stairs and outdoor surfaces.
The 8 stations include rings, getting up from the chair to the stands and going back, walking and catching balls, kicking balls, steps, circuits, going to bed and getting up and walking with speed. Each station will last 3 minutes with 3 minutes of rest and 1 minute to change stations. The participants will work in pairs as much as possible.
Third, minutes focused on the game in which activities that relate directly to the march are contemplated.
Intervention code [1] 314327 0
Rehabilitation
Intervention code [2] 314394 0
Treatment: Other
Comparator / control treatment
No control group' or similar.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319892 0
This is a composite primary outcome The primary result is the mobility in the march


The test that can be used to evaluate the march is Tinetti
The Functional Ambulation Score (FAC) (10).
The Gross Motor Function Measure (GMFM)
Timepoint [1] 319892 0
Three months of training with sessions of twice a week 90 minutes each session of physiotherapy. In addition, one month of initial evaluation and one month of final evaluation
Secondary outcome [1] 369814 0


Secondary outcome are symmetry of passage, fluidity of passage, trajectory, start of the march
The evaluation method are:

Tinetti scale
Timepoint [1] 369814 0
Five months including the initial and final evaluation
Secondary outcome [2] 372933 0
I will evaluate the strength in the all lower limb for each joint.

'Daniels Manual Muscle Testing'
Timepoint [2] 372933 0
Five months including the initial and final evaluation

Eligibility
Key inclusion criteria
• Women and men between 18 and 40 years old with cerebral palsy
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Subjects under 18 years of age or over 41 years old.
• Subjects with any other neurological disorder or constant assistance required for activities of daily living.
• Not having performed the tests mentioned in the inclusion criteria.
• Refusal to participate in the study.

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
29/04/2019
Date of last participant enrolment
Anticipated
3/06/2019
Actual
3/06/2019
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 21442 0
Ecuador
State/province [1] 21442 0
Pichincha

Funding & Sponsors
Funding source category [1] 302630 0
Self funded/Unfunded
Name [1] 302630 0
Carolina Paredes
Country [1] 302630 0
Ecuador
Primary sponsor type
Individual
Name
Carolina Paredes
Address
Sangolqui
urbanization "La colina"
Guayas 27 and esmeraldas
Country
Ecuador
Secondary sponsor category [1] 302544 0
None
Name [1] 302544 0
Address [1] 302544 0
Country [1] 302544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303258 0
Ethics Committee Spain. University committee Camilo Josè Cela
Ethics committee address [1] 303258 0
Urb. Villafranca del Castillo, Calle Castillo de Alarcón, 49, 28692 Villanueva de la Cañada, Madrid, Spain
Ethics committee country [1] 303258 0
Spain
Date submitted for ethics approval [1] 303258 0
26/04/2019
Approval date [1] 303258 0
29/04/2019
Ethics approval number [1] 303258 0

Summary
Brief summary
Group exercises in adults with cerebral palsy improve motor sequelae and benefit during walking.
The exercises improve the speed, balance and functionality in the march, as well as the cognition and the emotional part of the participant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93042 0
Miss Carolina Paredes
Address 93042 0
Pichincha
Sangolqui
Urbanizacion "La colina"
Guayas 27 and Esmeraldas
Country 93042 0
Ecuador
Phone 93042 0
+593987042956
Fax 93042 0
Email 93042 0
[email protected]
Contact person for public queries
Name 93043 0
Carolina Paredes
Address 93043 0
Pichincha
Sangolqui
Urbanizacion "La colina"
Guayas 27 and Esmeraldas
Country 93043 0
Ecuador
Phone 93043 0
+593987042956
Fax 93043 0
Email 93043 0
[email protected]
Contact person for scientific queries
Name 93044 0
Carolina Paredes
Address 93044 0
Pichincha
Sangolqui
Urbanizacion "La colina"
Guayas 27 and Esmeraldas
Country 93044 0
Ecuador
Phone 93044 0
+593987042956
Fax 93044 0
Email 93044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of teh individual participant data collected during the trial
When will data be available (start and end dates)?
inmediately following publication
no end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
all
How or where can data be obtained?
via email address [email protected]


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.