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Not Yet RecruitingNCT07247812

tSCS in Children and Young People With HCP

The Effects of Transcutaneous Spinal Cord Stimulation on Upper Extremity Function in Children and Young People With Hemiplegic Cerebral Palsy

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
University of Leeds · Academic / Other
Sex
All
Age
12 Years – 21 Years
Healthy volunteers
Not accepted

Summary

This work will examine if a technique called Transcutaneous Spinal cord stimulation (tSCS), when used with concurrent specific arm and hand exercises, helps improve arm and hand movements in CYP with HCP. Does Transcutaneous Spinal Cord Stimulation (tSCS), when combined with specific arm and hand exercises, improve upper limb function in children and young people (CYP) with Hemiplegic Cerebral Palsy (HCP)? -To determine the feasibility and effectiveness of Transcutaneous Spinal Cord Stimulation (tSCS) combined with targeted arm and hand exercises in improving the upper limb function in children and young people with Hemiplegic Cerebral Palsy (HCP).

Detailed description

Cerebral palsy (CP) is a condition that affects movement and posture due to brain development issues in babies or young children. Hemiplegic CP (HCP) is a condition where one side of the body is paralysed. Symptoms like stiffness in the arms and legs usually appear early and can make everyday tasks, such as reaching or holding objects difficult. Improving arm and hand function is crucial for increasing independence and quality of life for children with HCP. This study investigates a technique called Transcutaneous Spinal Cord Stimulation (tSCS). tSCS uses sticky pads placed on the skin to deliver a mild electrical current. This current stimulates nerves to help them send signals to the muscles, potentially improving arm and hand movements. Research has demonstrated that tSCS can provide benefits in the lower limb for children and young people (CYP) with CP, those with spinal cord injuries and healthy individuals. In this project, we will test the feasibility and effectiveness of tSCS in 18 CYP (aged 12-21 years) with HCP. The participant will attend two sessions. Each session will last approximately 60-90 minutes and will include: * A Baseline Assessment (before training) * A 30-minute Upper Limb Task Training (ULTT) * One session will involve transcutaneous spinal cord stimulation (tSCS) combined with ULTT * One session will involve ULTT only (no stimulation) * The order is randomised, meaning participants do the stimulation session first or second * A Post-Training Assessment

Conditions

Interventions

TypeNameDescription
DEVICEDigimer DS8RTranstcuatne Electrical stimulation will be delivered using the Digimer DS8R. The tSCS will be administered in one session only, during which participants will receive continuous tSCS simultaneously with Upper Limb Motor Training (ULTT).

Timeline

Start date
2025-12-01
Primary completion
2026-09-30
Completion
2026-09-30
First posted
2025-11-25
Last updated
2025-11-25

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07247812. Inclusion in this directory is not an endorsement.