NCT07525752

Brief Summary

PURPOSE: The purpose of this randomized controlled trial was to investigate the potential carry-over effects of a 6-week lower limb strengthening-based cross-training (CT) priming protocol, added to standard physical rehabilitation, on affected upper limb function in children aged 6-8 years with unilateral cerebral palsy (UCP), compared to standard physical rehabilitation alone. BACKGROUND: Children with unilateral cerebral palsy (UCP) experience motor impairments affecting both lower and upper limbs, significantly impacting functional independence. While rehabilitation often targets specific limbs, interventions may induce broader neuroplastic changes. Movement-based priming, particularly strengthening-based cross-training (CT) targeting the less-affected limb, has shown promise for improving contralateral lower limb function in UCP, likely via cross-education mechanisms involving central nervous system adaptations. However, it remains largely unexplored whether such lower limb-focused priming interventions can induce secondary "carry-over" effects, positively influencing the function of the ipsilaterally affected upper limb through potential mechanisms like widespread neural adaptations or improved postural stability. Addressing this gap is crucial for understanding the holistic impact of priming interventions and optimizing rehabilitation strategies. HYPOTHESES: There will be no statistically significant difference in the improvement of affected handgrip strength, grasping skills and functional UL Outcome Measure between children receiving lower limb CT priming plus standard rehabilitation and those receiving standard rehabilitation alone over the 6-week intervention period. RESEARCH QUESTION: Does the addition of a 6-week lower limb strengthening-based cross-training priming protocol to standard physical rehabilitation result in significantly greater improvements in affected upper limb function (specifically handgrip strength and grasping skills) compared to standard physical rehabilitation alone in children aged 6-8 years with unilateral cerebral palsy?

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
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 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 (1)

  • Handgrip Strength (HGS)

    Handgrip strength measured by Jamar hand dynamometer

    Baseline and after 6 weeks of training

Secondary Outcomes (1)

  • Peabody Developmental Motor Scales-2, Fine Motor subtest (PDMS-2 FM) - Grasping Age Equivalent

    Baseline and after 6 weeks of training

Study Arms (2)

Standard Rehabilitation Only

ACTIVE COMPARATOR

Children receive 60 minutes of standard physical rehabilitation targeting motor function, 3 sessions per week for 6 weeks, with no lower limb cross-training priming.

Other: Standard rehabilitation program

Lower Limb Cross-Training Priming + Standard Rehabilitation

EXPERIMENTAL

Children receive 10-15 minutes of lower limb strengthening-based cross-training priming of the less-affected limb, immediately followed by the same 60-minute standard rehabilitation program, 3 sessions per week for 6 weeks.

Other: Standard rehabilitation programOther: Lower Limb Cross-Training Priming

Interventions

60-minute physical therapy program including strengthening, balance, and functional activities for children with unilateral cerebral palsy.

Lower Limb Cross-Training Priming + Standard RehabilitationStandard Rehabilitation Only

10-15 minutes of lower limb strengthening-based cross-training of the less-affected limb used as movement-based priming prior to standard rehabilitation.

Lower Limb Cross-Training Priming + Standard Rehabilitation

Eligibility Criteria

Age6 Years - 8 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:

  • Children with 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)

  • Kumari R, Dybus A, Purcell M, Vuckovic A. Motor priming to enhance the effect of physical therapy in people with spinal cord injury. J Spinal Cord Med. 2025 Mar;48(2):312-326. doi: 10.1080/10790268.2024.2317011. Epub 2024 Feb 23.

    PMID: 38391261BACKGROUND
  • Stoykov ME, Madhavan S. Motor priming in neurorehabilitation. J Neurol Phys Ther. 2015 Jan;39(1):33-42. doi: 10.1097/NPT.0000000000000065.

    PMID: 25415551BACKGROUND

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 13, 2026

Study Start

January 1, 2026

Primary Completion

March 30, 2026

Study Completion

March 31, 2026

Last Updated

April 13, 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