- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484347
Combined Effects of Sensorimotor Integration and Post-facilitation Stretch in Autism Spectrum Disorder
Combined Effects of Sensorimotor Integration and Post-facilitation Stretch on Toe Walking and Foot Posture in Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism spectrum disorder (ASD) is a complex neurodevelopmental disease that involves communication, social interaction and language in different ways. The autism toe walker is affected by outside world contact refusal: touching the ground as little as possible, trying to avoid any contact. The pathological walking caused by myotendinous retraction of the sural muscles bilaterally, succeeding in transforming an equine "attitude" into structured clubfoot walking. Many therapy options have been described: no treatment, physical therapy or casting to stretch the gastrocnemius, soleus, and Achilles' tendon, surgical lengthening of the gastrocnemius, soleus and Achilles tendon, blocking plantar flexion.
Sensorimotor integration is the process by which motor behaviors and sensory system processing take place together, with motor actions being continuously guided by sensory information.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: maria khalid, MSOMPT
- Phone Number: 03315369768
- Email: maria.khalid@riphah.edu.pk
Study Locations
-
-
Punjab Province
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Islamabad, Punjab Province, Pakistan
- Recruiting
- Fauji Foundation Hospital
-
Contact:
- maria khalid, MSOMPT
- Phone Number: 03315369768
- Email: maria.khalid@riphah.edu.pk
-
Contact:
- Momina Tahir, MSOMPT*
-
Principal Investigator:
- Momina Tahir, MSOMPT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with diagnosed Mild Autism Spectrum Disorder
- Presenting with toe walk as a prominent feature of Autism Spectrum Disorder (e.g., more than 50% of steps observed during a gait assessment). Toe walking should be entirely because of Achilles tightness.
- Able to follow simple verbal commands.
- Sufficient gross motor skills present.
Exclusion Criteria:
- Toe walking due to neurological (e.g., cerebral palsy, spina bifida, peripheral neuropathy) or orthopedic disorders (e.g., clubfoot, leg length discrepancy > 1 cm, hip dysplasia, contractures not related to idiopathic toe walking) and other behavioral factors that could be the primary cause of toe walking will be excluded.
- History of Achilles tendon surgery or lower limb surgery.
- Current participation in another physical therapy intervention targeting gait or posture
- Severe behavioral/sensory issues that would interfere with treatment sessions i.e. severe Autism Spectrum Disorder with Attention Deficit Hyperactivity Disorder as well as mental retardation.
- Non-ambulatory children.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Post-Facilitation Stretch
Gastrocnemius and soleus stretch (standing and supine) • Ankle dorsiflexion with resistance (manual or band-assisted) |
Gastrocnemius and soleus stretch (standing and supine) Ankle dorsiflexion with resistance (manual or band-assisted)
|
|
Experimental: Sensorimotor integration and Post facilitation stretch
Sensorimotor integration is facilitated by positioning the child in a seated posture and instructing them to use both feet to retrieve toys from a water-filled bucket and transfer them to another container.
Other sensory motor integration activities involve play dough, hand imprinting etc.
|
Sensorimotor integration is facilitated by positioning the child in a seated posture and instructing them to use both feet to retrieve toys from a water-filled bucket and transfer them to another container.
Other sensory motor integration activities involve play dough, hand imprinting etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Posture Index (FPI-6)
Time Frame: 4 weeks
|
The Foot Posture Index (FPI) is a clinical tool used to assess and quantify the posture of the foot. Each of the six criteria is scored on a scale, typically from -2 to +2, with negative scores indicating supination, positive scores indicating pronation, and zero representing a neutral position. The individual scores are then summed to provide a total FPI score, which can range from -12 (highly supinated) to +12 (highly pronated). |
4 weeks
|
|
Universal Half Goniometer
Time Frame: 4 weeks
|
Goniometers are a type of instrument used for precisely measuring angles.
Goniometers consist of a graduated semicircle or full-circle where the measurements of angles are read, and two arms that meet at the vertex at the center of the semicircle or circle.
|
4 weeks
|
|
Sensory Profile (Short Form)
Time Frame: 4 weeks
|
The Short Sensory Profile (SSP) is a caregiver questionnaire used to assess sensory processing patterns in children, particularly those with autism spectrum disorder (ASD).
It helps identify how children respond to various sensory stimuli and how these responses might impact their daily lives.
The SSP is a shortened version of the Sensory Profile, designed for children aged 3 to 10 years.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria khalid, MSOMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Momina Tahir/02288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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