Transcranial Direct Current Stimulation and Treadmill in Cerebral Palsy

NCT07342660 | Completed

• 2 other identifiers: 42020194322019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cerebral Palsy (CP) is characterized by altered excitability in bilateral sensorimotor cortical areas. Previous research using unilateral anodal transcranial direct current stimulation (tDCS) has yielded inconsistent results, highlighting a need for alternative stimulation approaches. Objective: This study evaluated the feasibility, safety, and preliminary efficacy of combining bilateral anodal transcranial direct current stimulation (tDCS) over the sensorimotor cortices with treadmill training in children with CP. Methods: A within-subjects case series was conducted with five children with CP. Participants received ten sessions of treadmill training (at 50% of their maximum over-ground speed) concurrently with bilateral anodal tDCS. Outcomes, assessed pre- and post-intervention, included postural alignment (medio-lateral and anterior-posterior), ankle dorsiflexion range of motion, gait variability, walking tolerance (6-minute walk test), motor function (GMFM-66), and hip/knee range of motion. Statistical analysis was performed using paired t-tests and effect sizes (Hedges' g). Anticipated Impact: This study will pioneer a novel bilateral tDCS montage for CP rehabilitation. The findings are expected to provide critical insights into the synergistic relationship between neuromodulation and physical training, ultimately informing more effective, evidence-based interventions to enhance motor function and participation in this population.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral palsy; transcranial direct current stimulation; treadmill; gait function; balance

Outcome Measures

Primary Outcomes (5)

• Gait speed

  Gait speed (meters/second)

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

• Gait variability

  Gait variability (dimensionless autocorrelation coefficient)

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

• Walking endurance

  Walking endurance assessed using the 6-Minute Walk Test (distance in meters walked within 6 minutes intervals)

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

• Developmental Motor function

  Gross motor function measure - Item set scale (Total Score, Higher score good motor function development, lower score poor motor function development)

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

• Postural Alignment

  Postural alignment (medio-lateral displacement in cm) Postural alignment (anterior-posterior displacement in cm)

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Secondary Outcomes (2)

• Spasticity

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

• Joint Range of Motion

  Baseline (within 7 days prior to the first intervention session) Immediately post-intervention (within 7 days following completion of the 10-session intervention period; up to 4 weeks from baseline)

Study Arms (1)

tDCS & Treadmill

EXPERIMENTAL

The therapeutic protocol commenced with two treadmill familiarization sessions. This was followed by ten combined treatment sessions.

Other: transcranial direct current stimulation

Interventions

transcranial direct current stimulation OTHER

The therapeutic protocol commenced with two treadmill familiarization sessions. This was followed by ten combined treatment sessions, each consisting of a 12-minute interval: a 1-minute warm-up, a 10-minute simultaneous treadmill training and tDCS therapy period, and a 1-minute cool-down. Treadmill speed was initiated at 50% of the child's maximum ground speed from the 6-Minute Walk Test (6MWT) and was progressively increased based on individual tolerance.

Also known as: treadmill

tDCS & Treadmill

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gross Motor Function Classification System (GMFCS) level of I-III
• ability to walk independently for at least 10 meters
• IQ greater than 70

You may not qualify if:

• history of orthopedic surgery
• history of neurolytic blocks,
• history of Botox injections in the past six months
• Presence of concurrent orthopedic impairments
• Presence of epilepsy
• Presence of intracranial metal implants

Sponsors & Collaborators

• University of Sharjah: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

University of Sharjah

Sharjah city, Emirate of Sharjah, 27272, United Arab Emirates

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation; Exercise Test

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Hikmat Hadoush

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. / Associate professor

Model Details: Pilot study

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: January 15, 2026
• Study Start: July 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
• Access Criteria: De-identified IPD will be available upon reasonable request from qualified researchers for the purpose of academic, educational, or non-commercial research.

Locations

AE (1)