|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
28 June 2021 |
|
Main ID: |
ACTRN12614001227684 |
|
Date of registration:
|
24/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
18/11/2014 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://anzctr.org.au/ACTRN12614001227684.aspx |
|
Study type:
|
Interventional |
|
Study design:
|
Purpose: Treatment; Allocation: Randomised controlled trial;
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Inmaculada Riquelme
|
|
Address:
|
University of the Balearic Islands. Cra. Valldemossa, km. 7.5 07122 Palma de Mallorca
Spain |
|
Telephone:
|
+34 971171310 |
|
Email:
|
inmaculada.riquelme@uib.es |
|
Affiliation:
|
|
|
|
Name:
|
Dr Inmaculada Riquelme
|
|
Address:
|
University of the Balearic Islands. Cra. Valldemossa, km. 7.5 07122 Palma de Mallorca
Spain |
|
Telephone:
|
+34 971171310 |
|
Email:
|
inma.riquelme@uib.es |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Having an autism spectrum disorder.
Cognitive level allowing to understand and to follow simple instructions.
Exclusion criteria: Not having an autism spectrum disorder.
Age minimum:
4 Years
Age maximum:
15 Years
Gender:
Both males and females
|
|
Health Condition(s) or Problem(s) studied
|
|
Physical Medicine / Rehabilitation - Physiotherapy
|
Autism spectrum disorders;
Autism spectrum disorders
|
|
Mental Health - Autistic spectrum disorders
|
|
Intervention(s)
|
|
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.
|
|
Primary Outcome(s)
|
|
Touch thresholds, assessed with Von Frey monofilaments.[Pre-intervention and post-intervention (8 weeks).]
|
|
Pressure pain thresholds, assessed with an digital algometer.[Pre-intervention/post-intervention.]
|
|
Stereognosis and proprioception, assessed according to the Nottingham Sensory Assessment test.[Pre-intervention/Post-intervention.]
|
|
Secondary Outcome(s)
|
|
Motor function (Perdue Pegboard test)[Pre-intervention and post-intervention (8 weeks).]
|
|
Motor function (Block and Box test)[Pre-intervention and post-intervention.]
|
|
Source(s) of Monetary Support
|
|
Spanish Ministery of Economy and Competitiveness
|
|
Ethics review
|
Status: Approved
Approval date: 05/05/2014
Contact:
Ethics Committee on Research of the Balearic Islands
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
22/06/2021 |
|
Date Completed:
|
31/07/2015 |
|
URL:
|
|
|
|