NCT05522452

Brief Summary

The aim of this study is to investigate the effectiveness of synchronous telerehabilitation on improving upper extremity function in children with hemiparetic cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

August 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

August 29, 2022

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    12 weeks

  • The Selective Control of the Upper Extremity Scale (SCUES)

    This test was developed to evaluate the selective motor control of the upper extremity. It is a very practical and useful video-based assessment tool that can be applied in less than 15 minutes. No special equipment is required other than a video camera. It offers the opportunity to evaluate the selective movements of the shoulder, elbow, forearm, wrist and fingers for both right and left extremities. The person administering the test passively shows the participant the movements they are asked to do. Then the participant is asked to actively perform the movement shown. While performing the participant movements; Head, trunk and other extremity movements are taken with a video camera to provide the opportunity to observe. The degree of selective motor control is determined as 0-3 points for each joint, depending on the person's ability to perform movements and their shape.

    12 weeks

Secondary Outcomes (4)

  • ABILHAND-KIDS

    12 weeks

  • Shriners Hospital Upper Extremity Evaluation (SHUEE)

    12 weeks

  • Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)

    12 weeks

  • Pediatric Evaluation of Disability Inventory (PEDI)

    12 weeks

Other Outcomes (2)

  • Joint Range of Motion (ROM) Measurement

    12 weeks

  • Modified Tardieu Scale

    12 weeks

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

The telerehabilitation group will participate in the treatment in their homes. While the participants are performing the activities in their own homes, applications will be made via webcam-based software (Zoom) and synchronous access via video and audio from the physiotherapist's computer screen. The activities determined by the physiotherapist will be directed to the family, and the activities will be adapted and implemented according to the child's needs and functional level. Physiotherapy program will include the following applications: * Tone regulation * Active stretching and strengthening exercises * Gross and fine motor activities to improve bilateral hand use * Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning. * Arts and crafts activities

Other: Telerehabilitation

Face to face group

ACTIVE COMPARATOR

The face-to-face group will be treated in the clinic. To this group; The activities determined by the physiotherapist will be applied face to face. Physiotherapy program will include the following applications: * Tone regulation * Active stretching and strengthening exercises * Gross and fine motor activities to improve bilateral hand use * Daily living activities to improve upper extremity functional skills such as dressing, eating, and buttoning. * Arts and crafts activities

Other: Face to face rehabilitation

Interventions

Telerehabilitation program: Intervention will be applied by video interview for 12 weeks, 2 days a week, 45 minutes a day through the Zoom application. The application is free and can be installed on desktop or laptop computers, tablets and smartphones. The content of the activities to be done for that session by phone call to the parent before the interventions; Information will be given about the preparations such as keeping the materials on the table, suitable environment for that week's session and camera angle. Instructions and tips for parent support during the intervention will be given before and during the session. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.

Telerehabilitation group

Face to face program: Intervention will be applied by physiotherapist for 12 weeks, 2 days a week, 45 minutes a day in clinic. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.

Face to face group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presence of confirmed hemiparetic cerebral palsy
  • Manual Ability Classification System ≤ 3
  • Age between 6 and 18
  • Absence of major visual and/or auditory deficits
  • Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
  • Family members being active mobile phone or computer and internet users

You may not qualify if:

  • Seizures uncontrolled by therapy
  • Surgery and/or botulinum toxin-A injections in the upper limb within 6 months prior to the baseline assessment
  • Having a disabling behavioral disorder to treatment
  • Family's discontinuation of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Camden C, Pratte G, Fallon F, Couture M, Berbari J, Tousignant M. Diversity of practices in telerehabilitation for children with disabilities and effective intervention characteristics: results from a systematic review. Disabil Rehabil. 2020 Dec;42(24):3424-3436. doi: 10.1080/09638288.2019.1595750. Epub 2019 Apr 12.

    PMID: 30978110BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • AYSE ZENGIN ALPOZGEN, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 31, 2022

Study Start

October 19, 2022

Primary Completion

April 7, 2023

Study Completion

April 10, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations