NCT06231901

Brief Summary

This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

January 17, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 17, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

cerebral palsyoccupational performancefunctional statusCO-OPgoal directed training

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure (COPM)

    COPM is used to help individuals describe occupational performance problems and precedence in the areas of self-care, productivity, and leisure, in which they have difficulty performing.

    "up to 12 weeks"

  • Pediatric Evaluation of Disability Inventory (PEDI):

    PEDI is a measurement tool used to evaluate the functional status of children.

    "up to 12 weeks"

Study Arms (3)

coop plus traditional occupational therapy

EXPERIMENTAL

This group received the traditional occupational therapy plus CO-OP approach.

Other: CO-OPOther: traditional occupational therapy

GDT plus traditional occupational therapy

EXPERIMENTAL

This group received the traditional occupational therapy plus Goal directed training.

Other: GDTOther: traditional occupational therapy

traditional occupational therapy

OTHER

This group only received the traditional occupational therapy .

Other: traditional occupational therapy

Interventions

CO-OPOTHER

With a task-specific and goal-focused CO-OP approach; it is aimed to increase one's skills, to teach to use self-generated cognitive strategies, and to encourage generalization and transfer to new situations and activities.

Also known as: Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
coop plus traditional occupational therapy
GDTOTHER

Goal-directed training included the active implementation of task-specific activities related to the child's functional goals. Focusing on motor learning, GDT is an activity-based approach to therapy that uses meaningful, self-selected goals to provide opportunities for problem solving and indirectly guide the movements necessary to successfully meet task demands

Also known as: goal directed training
GDT plus traditional occupational therapy

The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.

GDT plus traditional occupational therapycoop plus traditional occupational therapytraditional occupational therapy

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • being between 5-10 years of age
  • being diagnosed with CP
  • having adequate language abilities to make contact with a therapist and be informed during intervention.

You may not qualify if:

  • they were receiving any other treatment
  • they had been diagnosed with mental retardation
  • they had serious vision or hearing problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyOrientation, Spatial

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpatial BehaviorBehavior

Study Officials

  • zeynep kolit, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Rüya gül temel, MSc

    HATAY MUSTAFA KEMAL ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR
  • Gamze ekici, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 30, 2024

Study Start

January 17, 2024

Primary Completion

March 31, 2024

Study Completion

April 1, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations