Robotic Hand Therapy for Children With Cerebral Palsy

NCT ID: NCT05711238

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-07-15

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.

Conditions

Cerebral Palsy; Hand Functions; Rehabilitation; Robotic Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robot Assisted Therapy Group

Investigators planned to apply robotic rehabilitation therapy with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 40 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience for the hands on the affected side of the children in the Robot Assisted Therapy Group group.

Amadeo (Tyromotion, Graz, Austria) is an end-effector device designed for the hand. It is a groove-shaped device attached to the forearm using magnets using bandages on the fingers.

Group Type: EXPERIMENTAL

Robotic rehabilitation

Intervention Type: OTHER

In robot-assisted therapy, the therapist selects different programs with personalized environments to train patients to strengthen limb muscles that have previously had difficulty with movements or are relatively weak. Active (individual finger movement, memory, motility, apple tree, target board, recycling bins, balloons, firefighter), auxiliary, and passive (cpm, cpm plus) treatment options are available in the system.

Conventional rehabilitation

Intervention Type: OTHER

Conventional therapy group In the pediatric rehabilitation of the children's hands on the affected side, an exercise program consisting of 40 minutes of hand finger joint range of motion exercises (passive, active assistive), strengthening exercises, and coarse and fine dexterity exercises was planned, accompanied by a physiotherapist experienced for at least 5 years.

Conventional Therapy Group

Conventional therapy group In the pediatric rehabilitation of the children's hands on the affected side, an exercise program consisting of 40 minutes of hand finger joint range of motion exercises (passive, active assistive), strengthening exercises, and coarse and fine dexterity exercises was planned, accompanied by a physiotherapist experienced for at least 5 years.

A total of 30 sessions of treatment were planned for both groups, 5 days a week. It will be recommended that they continue with the same dose of the medical treatment they have been using during the treatment program. Children will be evaluated by a physiatrist blinded to groups before and after treatment.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

Conventional therapy group In the pediatric rehabilitation of the children's hands on the affected side, an exercise program consisting of 40 minutes of hand finger joint range of motion exercises (passive, active assistive), strengthening exercises, and coarse and fine dexterity exercises was planned, accompanied by a physiotherapist experienced for at least 5 years.

Interventions

Robotic rehabilitation

In robot-assisted therapy, the therapist selects different programs with personalized environments to train patients to strengthen limb muscles that have previously had difficulty with movements or are relatively weak. Active (individual finger movement, memory, motility, apple tree, target board, recycling bins, balloons, firefighter), auxiliary, and passive (cpm, cpm plus) treatment options are available in the system.

Intervention Type: OTHER

Conventional rehabilitation

Conventional therapy group In the pediatric rehabilitation of the children's hands on the affected side, an exercise program consisting of 40 minutes of hand finger joint range of motion exercises (passive, active assistive), strengthening exercises, and coarse and fine dexterity exercises was planned, accompanied by a physiotherapist experienced for at least 5 years.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Sevda Adar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVDA ADAR

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Sevda Adar

Afyonkarahisar, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Adar S, Keskin D, Dundar U, Toktas H, Yesil H, Eroglu S, Eyvaz N, Bestas E, Demircan A. Effect of Robotic Rehabilitation on Hand Functions and Quality of Life in Children With Cerebral Palsy: A Prospective Randomized Controlled Study. Am J Phys Med Rehabil. 2024 Aug 1;103(8):716-723. doi: 10.1097/PHM.0000000000002430. Epub 2024 Jan 31.

Reference Type: DERIVED

PMID: 38320248 (View on PubMed)

Other Identifiers

SASPHAND

Identifier Type: -

Identifier Source: org_study_id