Structured Graphic Motor Therapy Facilitates Durable Motor Recovery Beyond Conventional Exercise: Evidence From a Comparative Pediatric Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Melbourne Assessment of Unilateral Upper Limb Function (MA2) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Structured Graphic Motor Therapy + Conventional Rehabilitation
Participants receive Structured Graphic Motor Therapy (SGMT) in addition to conventional upper-limb rehabilitation. The intervention consists of therapist-guided, progressively individualized trajectory-based drawing tasks combined with standard rehabilitation. Participants complete four supervised 70-minute sessions per week for 16 weeks.
干预措施: Structured Graphic Motor Therapy (SGMT) (Behavioral)
Conventional Upper-Limb Rehabilitation
Participants receive a time-matched program of conventional upper-limb rehabilitation consisting of active and active-assisted range-of-motion exercises, reaching activities, grasp-and-release practice, object manipulation, bilateral upper-limb activities, and functional task training. Participants complete four supervised 70-minute sessions per week for 16 weeks.
干预措施: Conventional Upper-Limb Rehabilitation (Other)
结局指标
主要结局
Change in Melbourne Assessment of Unilateral Upper Limb Function (MA2) Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Tigran Petrosyan
Associate Professor and Principal Investigator
Armenian State Institute of Physical Culture and Sport