Clinical trial NCT05711238: Robotic Hand Therapy for Children With Cerebral Palsy
Official title: The Effect of Robotic Hand Therapy on Hand Functions and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hand Functions
Rehabilitation
Robotic Rehabilitation
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is the most common physical disability in childhood. The term CP is defined as a group of persistent but non-progressive movement and posture disorders resulting from a defect or lesion of the immature brain. The overall prevalence of CP worldwide is 2.11 per 1000 live births.

There is evidence that 80% of children with CP have upper extremity involvement. In general, the acquisition of effective arm and hand skills for use in daily life is a complex process that not only requires neuromusculoskeletal integrity, but also includes various aspects of the child's abilities. Thus, in addition to the positive symptoms that typically present patterns of spasticity, children and adolescents with CP often have a poor ability to reach, grasp, release, and manipulate objects. They also have difficulty using their upper extremities to perform self-care and other activities.

Robot-assisted and computer-assisted methods may be valuable new strategies for improving the sensory-motor learning process in children with central motor impairment. These new technologies represent an attractive complement to existing physiotherapeutic and occupational therapy concepts.

In patients with difficulty in individual finger and hand movements, the AMADEO device (Tyromotion, Austria) can be used for unilateral distal training of the upper extremity. With this device, patients with little or no voluntary control of the hand and fingers can receive more or less passive training, while those with better distal function of the upper extremity can strength train by following the device or even against the device to a certain extent.

Implementation of robot-assisted therapy provides intense repetitive training, sensorimotor integration and cognitive engagement through targeted tasks; focuses primarily on functional motor performance. From previous studies, the use of robotic devices has been found to improve the kinematics, range of motion, muscle tone, postural control, and functionality of the upper and lower extremities in individuals with CP. Robotic hand therapy has started to take place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy in the pediatric group, larger-scale studies are needed. In this study, our aim is to investigate the effect of robotic hand therapy on hand functions and quality of life in children with CP.

Detailed description: Cerebral palsy (CP) is the most common physical disability in childhood. The term CP is defined as a group of persistent but non-progressive movement and posture disorders resulting from a defect or lesion of the immature brain. The overall prevalence of CP worldwide is 2.11 per 1000 live births.

There is evidence that 80% of children with CP have upper extremity involvement. In general, the acquisition of effective arm and hand skills for use in daily life is a complex process that not only requires neuromusculoskeletal integrity, but also includes various aspects of the child's abilities. Thus, in addition to the positive symptoms that typically present patterns of spasticity, children and adolescents with CP often have a poor ability to reach, grasp, release, and manipulate objects. They also have difficulty using their upper extremities to perform self-care and other activities.

Robot-assisted and computer-assisted methods may be valuable new strategies for improving the sensory-motor learning process in children with central motor impairment. These new technologies represent an attractive complement to existing physiotherapeutic and occupational therapy concepts.

In patients with difficulty in individual finger and hand movements, the AMADEO device (Tyromotion, Austria) can be used for unilateral distal training of the upper extremity. With this device, patients with little or no voluntary control of the hand and fingers can receive more or less passive training, while those with better distal function of the upper extremity can strength train by following the device or even against the device to a certain extent.

Implementation of robot-assisted therapy provides intense repetitive training, sensorimotor integration and cognitive engagement through targeted tasks; focuses primarily on functional motor performance. From previous studies, the use of robotic devices has been found to improve the kinematics, range of motion, muscle tone, postural control, and functionality of the upper and lower extremities in individuals with CP.

In a case series of 7 children with CP presenting the results of robotic therapy, it showed beneficial effects on body structure and function, including motor function, coordination, and brachioradial muscle recruitment, but no improvement in activity and participation skills. It has been stated that there is a need for new studies to be carried out with longer training periods and with the measurement of grip strength, daily living activity evaluation scales covering a wide variety of tasks.

In the first randomized controlled study with 16 children with CP, the results of upper extremity robot-assisted therapy were evaluated with body functions, structure and activity participation scales, and it was found that robotic therapy improved upper extremity kinematics and manual dexterity, but not functional activities and social participation.

Most robotic studies in children and adolescents with CP have relatively small sample sizes and few randomized controlled trials.

Robotic hand therapy has started to take place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy in the pediatric group, larger-scale studies are needed. In this study, our aim is to investigate the effect of robotic hand therapy on hand functions and quality of life in children with CP.

Eligibility criteria: Inclusion Criteria:

* grade 1-3 according to the manual ability classification system
* capable of taking multi-step commands
* able to sit in a chair

Exclusion Criteria:

* Having persistent pain in the upper extremity or hand (VAS\>40)
* with severe spasticity of the hand (MAS≥3) or contracture
* Fracture or operation in the upper extremity in the past 6 months
* Botulinum toxin injection to the upper extremity in the last 6 months
* skin ulcer
* severe vision and hearing impairment
* intense ataxia
* uncontrolled epilepsy

Primary outcomes:
measure: MACS (Manual Ability Classification System for Children with Cerebral Palsy)
timeFrame: 15 minutes
measure: Spasticity Evaluation
timeFrame: 5 minutes
Secondary outcomes:
measure: Jamar Dynamometer
timeFrame: 5 minutes
measure: Jebsen Taylor Hand Function Test
timeFrame: 45 minutes
measure: Box Block Test
timeFrame: 75 minutes
measure: Nine Hole Peg Test
timeFrame: 30 minutes
measure: ABILHAND- Kids Manual Ability Scale
timeFrame: 30 minutes
measure: Pediatric Functional Independence Measurement
timeFrame: 30 minutes
measure: Quality of Life Scale for Children - SP Module (PedsQL-CP)
timeFrame: 30 minutes
measure: Fugl Meyer Upper Extremity Assessment Questionnaire
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Sevda Adar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: SEVDA ADAR
role: PRINCIPAL_INVESTIGATOR
References: