Sensory-Enhanced Asynchronous Tele-Rehabilitation Model for Improving Function in Children With Cerebral Palsy (Tele-Rehab)
Sensory-Enhanced Asynchronous Tele-Rehabilitation Model for Improving Function in Children With Cerebral Palsy: A Randomized Controlled Trial
PURPOSE: This study evaluated the effectiveness of a Sensory-Enhanced Home-based Intensive Program (SE-HIP), delivered via asynchronous video guidance, compared to a Standard Home Program (SHP) on improving upper limb function in children with cerebral palsy (CP).
BACKGROUND: Children with cerebral palsy (CP) often have upper limb (UL) impairments that limit daily life and participation. Intensive, repetitive therapy is crucial, but traditional delivery has limitations. Home-based programs supported by tele-rehabilitation offer increased dosage and accessibility. Asynchronous models delivered via video guidance are flexible but are less studied for intensive upper limb therapy. Sensory processing deficits are common in cerebral palsy; integrating sensory enhancement may augment motor learning. Evidence combining sensory-enhanced intensive upper limb programs delivered asynchronously is lacking.
HYPOTHESES: The investigators hypothesized that children receiving the Sensory-Enhanced Home-based Intensive Program (SE-HIP) would demonstrate significantly greater improvements in primary upper limb functional outcomes, measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT), compared to those receiving the Standard Home Program (SHP).
RESEARCH QUESTION: Does a sensory-enhanced, asynchronous video-guided home program lead to significantly greater improvements in upper limb function (manual dexterity measured by the Box and Block Test (BBT) and the Nine-Hole Peg Test (NHPT)) compared to a standard video-guided home program in children with cerebral palsy (CP)?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Giza, Cairo Governorate, Egypt, 12613
- Faculty of Physical Therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mild spasticity (MAS 1 or 1+), independent ambulation (AFOs permitted), and the ability to follow simple instructions
Exclusion Criteria:
- Significant fixed deformities, cognitive or sensory impairments hindering participation, uncontrolled epilepsy, or recent interventions like botulinum toxin or orthopedic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensory-Enhanced Home-based Intensive Program (SE-HIP)
Children receive videos that include sensory preparation and intensive motor practice as part of the Sensory-Enhanced Home-based Intensive Program (SE-HIP).
|
Videos include sensory preparation and intensive motor practice delivered asynchronously at home.
|
|
Active Comparator: Standard Home Program (SHP)
Children receive videos that cover standard activities as part of the Standard Home Program (SHP).
|
Videos cover standard home exercise activities delivered asynchronously at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nine-Hole Peg Test
Time Frame: Baseline and after 6 weeks of training
|
Assesses fine manual dexterity (finger dexterity).
The patient places and removes nine pegs into a board as quickly as possible.
|
Baseline and after 6 weeks of training
|
|
Box and Block Test
Time Frame: Baseline and after 6 weeks of training
|
Assesses gross manual dexterity.
The patient moves small wooden blocks across a partition in 60 seconds
|
Baseline and after 6 weeks of training
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kashif M, Albalwi A, Mehdi Kazmi SA, Alharbi AA, Bashir K, Aqeel Aslam M, Ghaffar T. Role of telerehabilitation in the rehabilitation of children with cerebral palsy during COVID-19: A review. Medicine (Baltimore). 2024 Mar 1;103(9):e37214. doi: 10.1097/MD.0000000000037214.
- Molinaro A, Micheletti S, Pagani F, Garofalo G, Galli J, Rossi A, Fazzi E, Buccino G. Action Observation Treatment in a tele-rehabilitation setting: a pilot study in children with cerebral palsy. Disabil Rehabil. 2022 Apr;44(7):1107-1112. doi: 10.1080/09638288.2020.1793009. Epub 2020 Aug 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- P.T.REC/012/006150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.