Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001227684
Ethics application status
Approved
Date submitted
10/11/2014
Date registered
24/11/2014
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results information initially provided
22/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a somatosensory training program in sensitive perception and motor function in children with autism spectrum disorders.
Scientific title
Efficacy of somatosensory training on sensitive perception and motor function in children with autism spectrum disorders
Secondary ID [1] 285621 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorders 293469 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293750 293750 0 0
Physiotherapy
Mental Health 293843 293843 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Somatosensory stimulation (touching different textures, massage, object recognition, tactile pressure stimulation and traction games) in hands and face. This intervention will be administered in group sessions (5 children) with two physiotherapists. Participants will attend 2 sessions x 45 minutes per week for 8 weeks. Children attending at least than 80% of the sessions will be discarded in the data analysis.
Intervention code [1] 290574 0
Rehabilitation
Comparator / control treatment
No intervention.
Control group
Active

Outcomes
Primary outcome [1] 293547 0
Touch thresholds, assessed with Von Frey monofilaments.
Timepoint [1] 293547 0
Pre-intervention and post-intervention (8 weeks).
Primary outcome [2] 293621 0
Pressure pain thresholds, assessed with an digital algometer.
Timepoint [2] 293621 0
Pre-intervention/post-intervention.
Primary outcome [3] 293622 0
Stereognosis and proprioception, assessed according to the Nottingham Sensory Assessment test.
Timepoint [3] 293622 0
Pre-intervention/Post-intervention.
Secondary outcome [1] 311341 0
Motor function (Perdue Pegboard test)
Timepoint [1] 311341 0
Pre-intervention and post-intervention (8 weeks).
Secondary outcome [2] 311482 0
Motor function (Block and Box test)
Timepoint [2] 311482 0
Pre-intervention and post-intervention.

Eligibility
Key inclusion criteria
Having an autism spectrum disorder.
Cognitive level allowing to understand and to follow simple instructions.
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not having an autism spectrum disorder.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2014
Actual
18/11/2014
Date of last participant enrolment
Anticipated
Actual
30/06/2015
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6463 0
Spain
State/province [1] 6463 0

Funding & Sponsors
Funding source category [1] 290216 0
Government body
Name [1] 290216 0
Spanish Ministery of Economy and Competitiveness
Country [1] 290216 0
Spain
Primary sponsor type
University
Name
University of the Balearic Islands
Address
Cra. de Valldemossa, km. 7.5 07122 Palma
Country
Spain
Secondary sponsor category [1] 288927 0
None
Name [1] 288927 0
Address [1] 288927 0
Country [1] 288927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308833 0
Ethics Committee on Research of the Balearic Islands
Ethics committee address [1] 308833 0
Palma de Mallorca
Ethics committee country [1] 308833 0
Spain
Date submitted for ethics approval [1] 308833 0
16/01/2014
Approval date [1] 308833 0
05/05/2014
Ethics approval number [1] 308833 0
IB2244/14PI

Summary
Brief summary
To evaluate the efficacy of a somatosensory training program in somatosensory perception and motor function in children with autism spectrum disorders.
Trial website
Trial related presentations / publications
Reduction of Pain Sensitivity after Somatosensory Therapy in Children with Autism Spectrum Disorders.

Riquelme I, Hatem SM, Montoya P.

J Abnorm Child Psychol. 2018 Nov;46(8):1731-1740. doi: 10.1007/s10802-017-0390-6.
Public notes

Contacts
Principal investigator
Name 52622 0
Dr Inmaculada Riquelme
Address 52622 0
University of the Balearic Islands. Cra. Valldemossa, km. 7.5 07122 Palma de Mallorca
Country 52622 0
Spain
Phone 52622 0
+34 971171310
Fax 52622 0
Email 52622 0
[email protected]
Contact person for public queries
Name 52623 0
Dr Inmaculada Riquelme
Address 52623 0
University of the Balearic Islands. Cra. Valldemossa, km. 7.5 07122 Palma de Mallorca
Country 52623 0
Spain
Phone 52623 0
+34 971171310
Fax 52623 0
Email 52623 0
[email protected]
Contact person for scientific queries
Name 52624 0
Dr Inmaculada Riquelme
Address 52624 0
University of the Balearic Islands. Cra. Valldemossa, km. 7.5 07122 Palma de Mallorca
Country 52624 0
Spain
Phone 52624 0
+34 971171310
Fax 52624 0
Email 52624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Global data published


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12189Clinical study reportReduction of Pain Sensitivity after Somatosensory Therapy in Children with Autism Spectrum Disorders. Riquelme I, Hatem SM, Montoya P. J Abnorm Child Psychol. 2018 Nov;46(8):1731-1740. doi: 10.1007/s10802-017-0390-6.  



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Reduction of Pain Sensitivity after Somatosensory ... [More Details]

Documents added automatically
No additional documents have been identified.