Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05522452
Other study ID # PhD thesis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2022
Est. completion date April 10, 2023

Study information

Verified date June 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 10, 2023
Est. primary completion date April 7, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2