NCT07518511

Brief Summary

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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Nine-Hole Peg Test

    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

    Assesses gross manual dexterity. The patient moves small wooden blocks across a partition in 60 seconds

    Baseline and after 6 weeks of training

Study Arms (2)

Sensory-Enhanced Home-based Intensive Program (SE-HIP)

EXPERIMENTAL

Children receive videos that include sensory preparation and intensive motor practice as part of the Sensory-Enhanced Home-based Intensive Program (SE-HIP).

Other: Sensory-Enhanced Home-based Intensive Program (SE-HIP)

Standard Home Program (SHP)

ACTIVE COMPARATOR

Children receive videos that cover standard activities as part of the Standard Home Program (SHP).

Other: Standard Home Program (SHP)

Interventions

Videos cover standard home exercise activities delivered asynchronously at home.

Standard Home Program (SHP)

Videos include sensory preparation and intensive motor practice delivered asynchronously at home.

Sensory-Enhanced Home-based Intensive Program (SE-HIP)

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mild spasticity (MAS 1 or 1+), independent ambulation (AFOs permitted), and the ability to follow simple instructions

You may not qualify if:

  • Significant fixed deformities, cognitive or sensory impairments hindering participation, uncontrolled epilepsy, or recent interventions like botulinum toxin or orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 38428904BACKGROUND
  • 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.

    PMID: 32805150BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 8, 2026

Study Start

January 1, 2026

Primary Completion

March 30, 2026

Study Completion

March 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share de-identified individual participant data (IPD) from this trial outside the primary research group.

Locations