NCT04807790

Brief Summary

The aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 30, 2024

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 16, 2021

Last Update Submit

July 29, 2024

Conditions

Keywords

telerehabilitationcerebral palsyhome programparticipationactivity

Outcome Measures

Primary Outcomes (2)

  • Gross Motor Function Measure-88 (GMFM-88)

    GMFM-66 is a widely used scale to show the improvement in motor function. The KMFM-88 evaluates the motor functional structure in five main positions: supine and prone lying and rolling (A), sitting (B), crawling and kneeling (C), standing (D), walking, running and jumping (E). The highest score is 100, the lowest score is 0.

    At baseline

  • Quality of Upper Extremity Skills Test (QUEST)

    It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50.

    At baseline

Other Outcomes (8)

  • Segmental Assessment of Trunk Control (SATCO)

    At baseline

  • ABILHAND-KIDS

    At baseline

  • ABILOCO KIDS

    At baseline

  • +5 more other outcomes

Study Arms (2)

Telerehabilitation based structured home program group

EXPERIMENTAL

The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.

Other: Telerehabilitation based structured home program applications

Routine physiotherapy and rehabilitation group

NO INTERVENTION

Routine physiotherapy and rehabilitation practices, consist of activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches.

Interventions

The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.

Also known as: Routine physiotherapy and rehabilitation group
Telerehabilitation based structured home program group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being in preschool period (3-5 years old)
  • Receiving routine physiotherapy and rehabilitation services 2 sessions in a week
  • Family members being active mobile phone or computer and internet users

You may not qualify if:

  • Uncontrolled epileptic seizures
  • Incomplete assesments
  • Family's discontinuation of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06080, Turkey (Türkiye)

Location

Related Publications (1)

  • Sel SA, Gunel MK, Erdem S, Tuncdemir M. Effects of Telerehabilitation-Based Structured Home Program on Activity, Participation and Goal Achievement in Preschool Children with Cerebral Palsy: A Triple-Blinded Randomized Controlled Trial. Children (Basel). 2023 Feb 22;10(3):424. doi: 10.3390/children10030424.

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Doc.Dr.

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

February 10, 2021

Primary Completion

March 10, 2022

Study Completion

March 31, 2023

Last Updated

July 30, 2024

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations