- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525752
Carry-Over Effects of Lower Limb Cross-Training Priming on Upper Limb Function in Children With Unilateral Cerebral Palsy (CROSS-UP)
Carry-Over Effects of Lower Limb Cross-Training Priming on Upper Limb Function in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial
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?
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:
- Children with 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 |
|---|---|
|
Active Comparator: Standard Rehabilitation Only
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.
|
60-minute physical therapy program including strengthening, balance, and functional activities for children with unilateral cerebral palsy.
|
|
Experimental: Lower Limb Cross-Training Priming + Standard Rehabilitation
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.
|
60-minute physical therapy program including strengthening, balance, and functional activities for children with unilateral cerebral palsy.
10-15 minutes of lower limb strengthening-based cross-training of the less-affected limb used as movement-based priming prior to standard rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength (HGS)
Time Frame: Baseline and after 6 weeks of training
|
Handgrip strength measured by Jamar hand dynamometer
|
Baseline and after 6 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peabody Developmental Motor Scales-2, Fine Motor subtest (PDMS-2 FM) - Grasping Age Equivalent
Time Frame: Baseline and after 6 weeks of training
|
Grasping age equivalent measured by Peabody Developmental Motor Scales-2, Fine Motor subtest (PDMS-2 FM)
|
Baseline and after 6 weeks of training
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Stoykov ME, Madhavan S. Motor priming in neurorehabilitation. J Neurol Phys Ther. 2015 Jan;39(1):33-42. doi: 10.1097/NPT.0000000000000065.
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/012/006149
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.
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