Cerebral Palsy (CP)
Conditions
Keywords
Cerebral Palsy, upper limb, Task oriented and visuomotor training, Structured Graphic Motor Therapy, Fine Motor Skills, Graphic Motor Performance
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Graphic Motor Therapy (SGMT)
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.
OTHERConventional Upper-Limb Rehabilitation
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.
Sponsors
Armenian State Institute of Physical Culture and Sport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Because of the nature of the rehabilitation intervention, participants, treating therapists, and study investigators could not be blinded to treatment allocation. However, all clinical outcome assessments were performed by an independent physiotherapist who was blinded to group assignment. In addition, graphical trajectory sheets were anonymized and assigned unique identification codes before image acquisition and quantitative analysis to maintain assessor blinding throughout outcome evaluation.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to either Structured Graphic Motor Therapy (SGMT) plus conventional upper-limb rehabilitation or conventional upper-limb rehabilitation alone. Both groups receive interventions concurrently for 16 weeks, with outcomes compared between parallel study arms.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Melbourne Assessment of Unilateral Upper Limb Function (MA2) Score | 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. |
Countries
Armenia
Outcome results
None listed