NCT07753083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Cerebral Palsyupper limbTask oriented and visuomotor trainingStructured Graphic Motor TherapyFine Motor SkillsGraphic Motor Performance

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline to Week 16 (end of intervention)

Study Arms (2)

Structured Graphic Motor Therapy + Conventional Rehabilitation

EXPERIMENTAL

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.

Behavioral: Structured Graphic Motor Therapy (SGMT)

Conventional Upper-Limb Rehabilitation

ACTIVE COMPARATOR

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.

Other: Conventional Upper-Limb Rehabilitation

Interventions

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.

Structured Graphic Motor Therapy + Conventional 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.

Conventional Upper-Limb Rehabilitation

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armenian State Institute of Physical Culture and Sport

Yerevan, Yerevan, 0070, Armenia

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Principal Investigator

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 7, 2026

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 30, 2025

Last Updated

August 7, 2026

Record last verified: 2026-08

Locations