tSCS in Children and Young People With HCP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorUniversity of Leeds

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age and Gender: Boys and girls aged 12 to 21 years.

Diagnosis: Are diagnosed with Hemiplegic Cerebral Palsy (HCP).

Hand Function: Are experiencing difficulties with hand functions in daily activities.

Medical Stability: Have stable medical conditions without cardiopulmonary disease or seizures.

Disqualifiers

Other Neurological Conditions: Have neurological diseases other than cerebral palsy.

Blood Pressure: Have uncontrolled or high blood pressure.

Recent Surgeries: Have recently undergone significant surgeries (neurological, cardiac, respiratory, or metabolic) without sufficient recovery time.

Severe Diseases: Have cardiovascular or pulmonary diseases.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Digimer DS8R

    Device

    Transtcuatne 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).

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: transcutaneous spinal cord stimulation (tSCS) combined with Upper Limb Training Task (ULTT)Experimental treatment 1 intervention
Group B: ULTT ONLYNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Participants with stimulation-site skin reaction (Yes/No; photographic assessment)

Standardised photographs of the back will be obtained at each time point and reviewed by an independent clinician (not part of the study team). A skin reaction is defined as any visible erythema at/near the electrode site and will be recorded on a Yes/No erythema scale (0 = No erythema; 1 = Yes erythema). Results will be reported as the number and proportion of participants with ≥1 skin reaction during the session and by time point.

Time frame
At the first session: Baseline (pre-tSCS) and immediately post-tSCS
2

Heart Rate Category (beats per minute)

Heart rate will be measured immediately before and after tSCS using an OMRON M3 device. For each participant, a blinded independent clinician will classify the post-stimulation change relative to Baseline as one of three categories: Increased, Decreased, or No Apparent Change. Study results will be summarised as the number and proportion of participants in each category and described narratively.

Time frame
[Time Frame: Baseline (pre-tSCS); During tSCS (10 minutes after start); Immediately post-tSCS (within 10 minutes after end) during a single session.
3

Hand Strength Index (dynamometry)

Handgrip and pinch strength will be measured with handheld dynamometers (adjustable handle/pads; peak-hold). At each time point, participants perform 3 maximal attempts per measure; the average (mean) is calculated for handgrip and for pinch. Results will be summarised as mean (SD) by timepoint and change from pre to post within each session (Post - Pre). Component means (handgrip and pinch) will be presented descriptively as supportive information.

Time frame
Session 1[first visit]: Pre (Baseline, before tSCS); Session 1 [first visit]: Post (immediately after tSCS, within 10 minutes); Session 2 [second visit]: Pre (Baseline, before tSCS); Session 2 [sv]: Post (immediately after tSCS, within 10 minutes)
4

Jebsen-Taylor Hand Function Test total time (seconds)

Hand function will be assessed with the Jebsen-Taylor Hand Function Test (JTHFT). The protocol includes three subtests: (1) picking up small common objects; (2) stacking checkers; (3) lifting large light and large heavy cans (\~1 lb). Each subtest is timed to completion. Testing is administered with the less affected hand first, then the more affected hand; the primary outcome is the Total Score for the more affected hand. Results will be summarised as mean (SD) seconds by timepoint and change from pre to post within each session (Post - Pre). (Scores for the less affected hand may be presented descriptively as supportive data.)

Time frame
Session 1[first visit]: Pre (Baseline, before tSCS); Session 1 [first visit]: Post (immediately after tSCS, within 10 minutes); Session 2 [second visit]: Pre (Baseline, before tSCS); Session 2 [sv]: Post (immediately after tSCS, within 10 minutes)

Secondary outcomes

1

Participant-reported experience with stimulation - response frequencies (project-specific questionnaire)

A project-specific Participant Feedback Questionnaire (PFQ-tSCS), completed by the participant or caregiver, will capture experience with stimulation across predefined domains: comfort, ease of participation, sensations during the session, skin reactions, discomfort/adverse effects, and overall satisfaction. Items use ordered categorical response options (e.g., None/Mild/Moderate/Severe or Strongly disagree → Strongly agree), plus optional free-text. Outcome data will be reported as the number and proportion of participants in each response category for each item; free-text responses will be summarised narratively.

Time frame
Immediately post-final tSCS session [first session] (within 10 minutes), single administration.
2

ABILHAND-Kids total raw score (0-42; higher = better manual ability)

Manual ability will be assessed with the ABILHAND-Kids Questionnaire (21 items; response options: Impossible = 0, Difficult = 1, Easy = 2). The total raw score is the sum across items (higher scores indicate better manual ability). The questionnaire may be completed by the participant or a caregiver proxy per instrument guidance. Results will be summarised as mean (SD) total score by timepoint and change from Pre to Post within each session (Post - Pre)

Time frame
Session 1[first visit]: Pre (Baseline, before tSCS); Session 1 [first visit]: Post (immediately after tSCS, within 10 minutes); Session 2 [second visit]: Pre (Baseline, before tSCS); Session 2 [sv]: Post (immediately after tSCS, within 10 minutes).

Other outcomes

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