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Completed

NCT Number: NCT07753083

Structured Graphic Motor Therapy in Pediatric CP

Structured Graphic Motor Therapy (SGMT) is a novel task-oriented rehabilitation approach that uses standardized, progressively challenging drawing trajectories to improve upper-limb motor function in children with cerebral palsy. This pilot randomized controlled trial will compare SGMT combined with conventional rehabilitation with conventional upper-limb rehabilitation alone over a 16-week intervention period. Standardized clinical assessments and quantitative image-derived measures of graphical motor performance will be used to evaluate changes in motor function, visuomotor coordination, and movement quality.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armenian State Institute of Physical Culture and Sport

Yerevan, 0070, Armenia

About this study

Upper-limb dysfunction is a major cause of activity limitation and reduced independence in children with cerebral palsy. Although conventional physiotherapy and occupational therapy improve motor performance, persistent deficits in fine motor control, visuomotor integration, and movement precision remain common. Structured Graphic Motor Therapy (SGMT) was developed as a standardized rehabilitation intervention based on principles of task-specific practice, motor learning, progressive overload, intrinsic visual feedback, and experience-dependent neuroplasticity. Rather than emphasizing artistic expression, SGMT employs individualized graphical trajectories of increasing complexity to promote coordinated upper-limb movement, continuous error correction, and sensorimotor integration.

This assessor-blinded pilot randomized controlled trial will enroll children aged 8-12 years with unilateral or predominantly unilateral cerebral palsy. Participants will be randomly assigned to receive either SGMT in addition to conventional rehabilitation or a time-matched program of conventional upper-limb rehabilitation alone. Both groups will complete four supervised 70-minute sessions per week for 16 weeks. Clinical outcomes will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function (MA2) and selected Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) subtests. Exploratory quantitative image-derived measures, including the Graphic Motor Performance Index (GMPI), will also be evaluated. Assessments will be performed at baseline, Week 8, Week 16, and 12-week follow-up to determine the feasibility, safety, and preliminary effectiveness of SGMT and to generate data for a future definitive multicenter randomized clinical trial.

These sections conform well to the style typically expected by ClinicalTrials.gov: the Brief Summary is concise, while the Detailed Description explains the scientific rationale, study design, intervention, outcomes, and objectives without presenting study results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 8 to 12 years. Confirmed diagnosis of cerebral palsy with unilateral or predominantly unilateral upper-limb motor impairment.

Sufficient voluntary movement of the affected upper limb to grasp and manipulate a drawing instrument on a supported horizontal surface.

Adequate visual, auditory, cognitive, and communication abilities to understand study instructions and complete standardized rehabilitation tasks.

Ability to follow standardized two-step verbal commands. Written informed consent provided by a parent or legal guardian and age-appropriate assent provided by the child.

Exclusion criteria

  • Uncontrolled epilepsy. Fixed upper-limb contracture preventing completion of the intervention tasks. Orthopedic surgery involving the upper limb within the previous 6 months. Botulinum toxin injection affecting the upper limb within the previous 6 months.

Severe uncorrected visual impairment. Clinically significant upper-limb pain that interferes with task performance. Unstable medical condition that could interfere with participation. Participation in another intensive upper-limb rehabilitation program during the study period.

Treatment and study plan

Structured Graphic Motor Therapy (SGMT)

Behavioral

Structured Graphic Motor Therapy (SGMT) is a therapist-guided, task-oriented rehabilitation intervention using standardized, progressively individualized graphical trajectories to improve upper-limb motor function, visuomotor integration, movement precision, and motor learning. Training incorporates repetitive practice, intrinsic visual feedback, and progressive task complexity over 16 weeks.

Conventional Upper-Limb Rehabilitation

Other

Conventional upper-limb rehabilitation consists of active and active-assisted range-of-motion exercises, reaching, grasp-and-release practice, object transfer, forearm pronation and supination, wrist and finger exercises, bilateral upper-limb activities, and functional task practice delivered over 16 weeks.

Primary outcomes

  1. Change in Melbourne Assessment of Unilateral Upper Limb Function (MA2) Score

    Time frame: Baseline to Week 16 (end of intervention)

    The primary outcome is the change in upper-limb motor function measured using the Melbourne Assessment of Unilateral Upper Limb Function, Second Edition (MA2). The MA2 evaluates movement quality, range of motion, dexterity, fluency, and accuracy during standardized unilateral upper-limb tasks in children with cerebral palsy. Higher scores indicate better upper-limb motor performance.

Sponsors and collaborators

Lead sponsor

Armenian State Institute of Physical Culture and Sport

Other

Registry information

Official study title

Structured Graphic Motor Therapy Facilitates Durable Motor Recovery Beyond Conventional Exercise: Evidence From a Comparative Pediatric Case Series

Acronym: SGMT-CP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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