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Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Face to face rehabilitation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • İstanbul University Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation group

Face to face group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

ABILHAND-KIDS
t evaluates hand skills in children with CP according to the activity frames of ICF-CY. It consists of 21 items. The highest score is 20, the lowest score is 0.
Shriners Hospital Upper Extremity Evaluation (SHUEE)
SHUEE is an assessment developed to measure upper extremity function in children with hemiplegic cerebral palsy. SHUEE is a video-based assessment administered by an occupational therapist using standardized objects and tasks. The evaluation takes about 15 minutes.
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)
This instrument is useful for evaluating interventions designed to improve the lives of children.
Pediatric Evaluation of Disability Inventory (PEDI)
Pediatric Evaluation of Disability Inventory assesses key functional capabilities and performance in children ages 6 months to 7 years. PEDI is also useful for older children whose functional abilities are lower than those of seven-year-olds without disabilities.

Full Information

First Posted
August 29, 2022
Last Updated
June 13, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05522452
Brief Title
Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP
Official Title
Comparison of Synchronous Telerehabilitation and Face to Face Method for Improving Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
46 children with hemiparetic cerebral palsy who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into two groups. The groups are: a) the synchronous telerehabilitation group; b) face to face rehabilitation group. Both groups will receive physiotherapy 2 days a week (1 session of 45 minutes) for 12 weels, for a total of 24 sessions. Evaluations will be made at baseline and the end of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm Description
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
Arm Title
Face to face group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Face to face rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Upper Extremity Skills Test (QUEST)
Description
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
Time Frame
12 weeks
Title
The Selective Control of the Upper Extremity Scale (SCUES)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ABILHAND-KIDS
Description
t evaluates hand skills in children with CP according to the activity frames of ICF-CY. It consists of 21 items. The highest score is 20, the lowest score is 0.
Time Frame
12 weeks
Title
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Description
SHUEE is an assessment developed to measure upper extremity function in children with hemiplegic cerebral palsy. SHUEE is a video-based assessment administered by an occupational therapist using standardized objects and tasks. The evaluation takes about 15 minutes.
Time Frame
12 weeks
Title
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)
Description
This instrument is useful for evaluating interventions designed to improve the lives of children.
Time Frame
12 weeks
Title
Pediatric Evaluation of Disability Inventory (PEDI)
Description
Pediatric Evaluation of Disability Inventory assesses key functional capabilities and performance in children ages 6 months to 7 years. PEDI is also useful for older children whose functional abilities are lower than those of seven-year-olds without disabilities.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Joint Range of Motion (ROM) Measurement
Description
Individuals' ROM degrees will be evaluated before and after the treatment using a electronic goniometer in the supine position. Individuals' shoulder flexion, abduction, internal and external rotation, elbow and wrist flexion and extension painless active ROM measurements will be evaluated and recorded.
Time Frame
12 weeks
Title
Modified Tardieu Scale
Description
Tardieu is a scale for measuring spasticity that takes into account resistance to passive movement at both slow and fast speed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYSE ZENGIN ALPOZGEN, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul University Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30978110
Citation
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.
Results Reference
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Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP

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