Robotic Hand Therapy for Children With Cerebral Palsy

NCT05711238 | Completed

• 1 other identifier: SASPHAND
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Hand Functions; Rehabilitation; Robotic Rehabilitation

Outcome Measures

Primary Outcomes (2)

• MACS (Manual Ability Classification System for Children with Cerebral Palsy)

  It is designed to classify how children with CP aged 4-18 use their hands while manipulating objects in daily life. The starting point of MACS is in upper extremity function, but it is also influenced by environmental, personal and contextual factors. It is designed to reflect the child's typical manual performance. MACS is a five-level system where level I represents the best dexterity and level V indicates that the child is not using their hands for functional purposes. It is intended to indicate the level that best represents the child's usual performance at home, school, and community settings. The Turkish version of the MACS has been found to be valid and reliable and is recommended to be suitable for the assessment of manual dexterity in the Turkish population.

  15 minutes

• Spasticity Evaluation

  It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in flexion and extension.

  5 minutes

Secondary Outcomes (8)

• Jamar Dynamometer

  5 minutes

• Jebsen Taylor Hand Function Test

  45 minutes

• Box Block Test

  75 minutes

• Nine Hole Peg Test

  30 minutes

• ABILHAND- Kids Manual Ability Scale

  30 minutes

Study Arms (2)

Robot Assisted Therapy Group

EXPERIMENTAL

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.

Other: Robotic rehabilitation; Other: Conventional rehabilitation

Conventional Therapy Group

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

Interventions

Robotic rehabilitation 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.

Robot Assisted Therapy Group

Conventional rehabilitation 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; Robot Assisted Therapy Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Sevda Adar

Afyonkarahisar, 03100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38320248 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• SEVDA ADAR

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 2, 2023
• Study Start: November 15, 2021
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

TU (1)