The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy

NCT ID: NCT06352762

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2017-12-15

Brief Summary

Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).

Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level.

Detailed Description

Cerebral Palsy (CP) is a permanent but non-progressive neurodevelopmental disorder that occurs in the immature brain and causes activity limitations in children. Epilepsy, cognitive disorders, behavioral disorders, visual-hearing losses and sensory disorders may be observed in children with CP along with motor damage. Motor dysfunction disorders constitute one of the most basic problems in patients with CP. Hand-arm coordination disorders, grip disorders and sensory disorders in the upper extremities negatively affect the daily life activities and functional independence levels of patients. It has been shown that neglect occurs with advancing age in cases with CP when upper limb treatment is delayed, and compensation mechanisms develop involving the use of unaffected side upper limbs to ensure daily living activities. Upper limb functional skills are very important to be able to perform daily life activities. It is not possible to perform activities such as holding and releasing objects, reaching for objects with non-functional upper limbs. Abnormal posture and deformities caused by spasticity restrict the functions of the upper extremities, make daily living activities difficult and increase the burden of people caring for the child. With the technological developments in recent years, virtual reality applications and robotic rehabilitation programs play an important role in CP rehabilitation. Significant improvements have been shown, especially in the development of walking, balance and postural control. Intensive practical, frequent repetitive movements and functional activities can be provided simultaneously in the same session with robotic rehabilitation applications. In the literature, the effects of robotic rehabilitation applications have been investigated in adult neurological patients. In pediatric patients, studies generally focus on lower limb function and walking. The number of studies examining the effect of robotic rehabilitation on upper limb functions in children with CP are limited. Based on these deficiencies in the literature, the purpose of the planned study was to examine the effect of upper limb robotic rehabilitation on upper limb functions and functional independence level in children diagnosed with spastic hemiparetic CP.

Conditions

Spastic Hemiplegic Cerebral Palsy; Upper Extremity Paresis; Robotic Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional physiotherapy

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions.

Robotic Rehabilitation

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. In addition, upper extremity robotic rehabilitation was applied.

Group Type: EXPERIMENTAL

Robotic Rehabilitation

Intervention Type: OTHER

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. An additional 30 minutes of robotic rehabilitation was applied to the conventional physiotherapy program. Robotic rehabilitation was applied after each session of conventional physiotherapy applications.

Interventions

Conventional physiotherapy

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions.

Intervention Type: OTHER

Robotic Rehabilitation

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. An additional 30 minutes of robotic rehabilitation was applied to the conventional physiotherapy program. Robotic rehabilitation was applied after each session of conventional physiotherapy applications.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with spastic hemiparetic CP
• Upper extremity muscle tone between 1-3 according to the Modified Ashworth Scale
• According to Gross Motor Functional Clasification System level 1-2-3
• Able to understand simple instructions

Exclusion Criteria

• Having a history of epilepsy
• Having botox in the last 6 months
• Having surgery in the last 6 months

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

Nuriye BUYUKTAS

The Effects of Upper Extremity Robotic Rehabilitation in Children with Spastic Hemiparetic Cerebral Palsy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuriye Büyüktaş, MsC

Role: PRINCIPAL_INVESTIGATOR

Izmir Bakircay University

Locations

Nuriye Büyüktaş

Bursa, Nilüfer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Izmir Dokuz Eylul University

Identifier Type: -

Identifier Source: org_study_id