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

Comparison of Synchronous Telerehabilitation and Face to Face Method for Improving Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Telerehabilitation; Other: Face to face rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation group; 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; 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.
Active Comparator: Face to face group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	12 weeks
Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL)	This instrument is useful for evaluating interventions designed to improve the lives of children.	12 weeks
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.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint Range of Motion (ROM) Measurement	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.	12 weeks
Modified Tardieu Scale	Tardieu is a scale for measuring spasticity that takes into account resistance to passive movement at both slow and fast speed.	12 weeks

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Principal Investigator: Ayse Zengin Alpozgen, PhD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: PhD Thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No